# Non-small cell lung cancer

The EU has approved 84 indications of 37 drugs in non-small cell lung cancer. 56 of them need a biomarker result: EGFR (19), ALK (12), PD-L1 (12), BRAF (4), ROS1 (3), KRAS (2), MET (2), HER2 (1) and 1 other. 6 tumour-agnostic approvals also apply when the tumour carries the alteration.

## Approved indications

### ALK fusion

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Alectinib](https://oncolabels.com/drugs/alectinib) (Alecensa) | ALK fusion | Monotherapy | Adjuvant | After complete tumour resection; High risk of recurrence |
| [Alectinib](https://oncolabels.com/drugs/alectinib) (Alecensa) | ALK fusion | Monotherapy | 1st line, advanced | - |
| [Ceritinib](https://oncolabels.com/drugs/ceritinib) (Zykadia) | ALK fusion | Monotherapy | 1st line, advanced | - |
| [Crizotinib](https://oncolabels.com/drugs/crizotinib) (Xalkori) | ALK fusion | Monotherapy | 1st line, advanced | - |
| [Alectinib](https://oncolabels.com/drugs/alectinib) (Alecensa) | ALK fusion | Monotherapy | 2nd line, advanced | Previously treated with crizotinib |
| [Atezolizumab](https://oncolabels.com/drugs/atezolizumab) (Tecentriq) | ALK fusion | + bevacizumab, paclitaxel and carboplatin | 2nd line, metastatic | Non-squamous only; After failure of appropriate targeted therapies |
| [Brigatinib](https://oncolabels.com/drugs/brigatinib) (Alunbrig) | ALK fusion | Monotherapy | 2nd line, advanced | Previously treated with crizotinib |
| [Ceritinib](https://oncolabels.com/drugs/ceritinib) (Zykadia) | ALK fusion | Monotherapy | 2nd line, advanced | Previously treated with crizotinib |
| [Crizotinib](https://oncolabels.com/drugs/crizotinib) (Xalkori) | ALK fusion | Monotherapy | 2nd line, advanced | Previously treated |
| [Lorlatinib](https://oncolabels.com/drugs/lorlatinib) (Lorviqua) | ALK fusion | Monotherapy | 2nd line, advanced | Disease has progressed after alectinib or ceritinib as the first ALK tyrosine kinase inhibitor (TKI) therapy, or crizotinib and at least one other ALK TKI |
| [Brigatinib](https://oncolabels.com/drugs/brigatinib) (Alunbrig) | ALK fusion | Monotherapy | Advanced | No prior ALK inhibitor |
| [Lorlatinib](https://oncolabels.com/drugs/lorlatinib) (Lorviqua) | ALK fusion | Monotherapy | Advanced | Previously not treated with an ALK inhibitor |

### BRAF mutation

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Binimetinib](https://oncolabels.com/drugs/binimetinib) (Mektovi) | BRAF V600E | + encorafenib | Advanced | - |
| [Dabrafenib](https://oncolabels.com/drugs/dabrafenib) (Tafinlar) | BRAF V600 | + trametinib | Advanced | - |
| [Encorafenib](https://oncolabels.com/drugs/encorafenib) (Braftovi) | BRAF V600E | + binimetinib | Advanced | - |
| [Trametinib](https://oncolabels.com/drugs/trametinib) (Mekinist) | BRAF V600 | + dabrafenib | Advanced | - |

### EGFR mutation

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Osimertinib](https://oncolabels.com/drugs/osimertinib) (Tagrisso) | EGFR exon 19 deletions or exon 21 (L858R) | Monotherapy | Adjuvant | After complete tumour resection; Stage IB-IIIA |
| [Amivantamab](https://oncolabels.com/drugs/amivantamab) (Rybrevant) | EGFR exon 20 insertion | + carboplatin and pemetrexed | 1st line, advanced | - |
| [Amivantamab](https://oncolabels.com/drugs/amivantamab) (Rybrevant) | EGFR exon 19 deletions or exon 21 L858R | + lazertinib | 1st line, advanced | - |
| [Bevacizumab](https://oncolabels.com/drugs/bevacizumab) (Avastin) | EGFR mutation | + erlotinib | 1st line, advanced | Non-squamous only |
| [Dacomitinib](https://oncolabels.com/drugs/dacomitinib) (Vizimpro) | EGFR-activating mutation | Monotherapy | 1st line, advanced | - |
| [Erlotinib](https://oncolabels.com/drugs/erlotinib) (Tarceva) | EGFR mutation | Monotherapy | 1st line, advanced | - |
| [Lazertinib](https://oncolabels.com/drugs/lazertinib) (Lazcluze) | EGFR exon 19 deletions or exon 21 L858R | + amivantamab | 1st line, advanced | - |
| [Osimertinib](https://oncolabels.com/drugs/osimertinib) (Tagrisso) | EGFR exon 19 deletions or exon 21 (L858R) | + pemetrexed and platinum-based chemotherapy | 1st line, advanced | - |
| [Osimertinib](https://oncolabels.com/drugs/osimertinib) (Tagrisso) | EGFR mutation | Monotherapy | 1st line, advanced | - |
| [Ramucirumab](https://oncolabels.com/drugs/ramucirumab) (Cyramza) | EGFR mutation | + erlotinib | 1st line, metastatic | - |
| [Erlotinib](https://oncolabels.com/drugs/erlotinib) (Tarceva) | EGFR mutation | Monotherapy | Maintenance, advanced | Stable disease after first-line chemotherapy |
| [Osimertinib](https://oncolabels.com/drugs/osimertinib) (Tagrisso) | EGFR exon 19 deletions or exon 21 (L858R) | Monotherapy | Consolidation, locally advanced | After platinum-based chemoradiation therapy without disease progression; Unresectable; disease has not progressed during or following platinum-based chemoradiation therapy |
| [Amivantamab](https://oncolabels.com/drugs/amivantamab) (Rybrevant) | EGFR exon 19 deletions or exon 21 L858R | + carboplatin and pemetrexed | 2nd line, advanced | After failure of prior therapy including an EGFR tyrosine kinase inhibitor (TKI) |
| [Amivantamab](https://oncolabels.com/drugs/amivantamab) (Rybrevant) | EGFR exon 20 insertion | Monotherapy | 2nd line, advanced | After failure of platinum-based therapy |
| [Atezolizumab](https://oncolabels.com/drugs/atezolizumab) (Tecentriq) | EGFR mutation | + bevacizumab, paclitaxel and carboplatin | 2nd line, metastatic | Non-squamous only; After failure of appropriate targeted therapies |
| [Erlotinib](https://oncolabels.com/drugs/erlotinib) (Tarceva) | EGFR mutation | Monotherapy | 2nd line, advanced | After failure of at least one prior chemotherapy regimen |
| [Afatinib](https://oncolabels.com/drugs/afatinib) (Giotrif) | Activating EGFR mutation(s) | Monotherapy | Advanced | EGFR TKI-naïve |
| [Gefitinib](https://oncolabels.com/drugs/gefitinib) (Iressa) | Activating mutations of EGFR-TK | Monotherapy | Advanced | - |
| [Osimertinib](https://oncolabels.com/drugs/osimertinib) (Tagrisso) | EGFR T790M | Monotherapy | Advanced | - |

### HER2 mutation

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Trastuzumab deruxtecan](https://oncolabels.com/drugs/trastuzumab-deruxtecan) (Enhertu) | HER2 mutation | Monotherapy | 2nd line, advanced | After platinum-based chemotherapy with or without immunotherapy |

### KRAS mutation

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Adagrasib](https://oncolabels.com/drugs/adagrasib) (Krazati) | KRAS G12C | Monotherapy | 2nd line, advanced | Disease progression after at least one prior systemic therapy |
| [Sotorasib](https://oncolabels.com/drugs/sotorasib) (Lumykras) | KRAS G12C | Monotherapy | 2nd line, advanced | After at least one prior line of systemic therapy |

### MET mutation

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Capmatinib](https://oncolabels.com/drugs/capmatinib) (Tabrecta) | Alterations leading to METex14 skipping | Monotherapy | 2nd line, advanced | After prior treatment with immunotherapy and/or platinum-based chemotherapy |
| [Tepotinib](https://oncolabels.com/drugs/tepotinib) (Tepmetko) | Leading to mesenchymal-epithelial transition factor gene exon 14 (METex14) skipping | Monotherapy | 2nd line, advanced | After prior treatment with immunotherapy and/or platinum-based chemotherapy |

### PD-L1

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Nivolumab](https://oncolabels.com/drugs/nivolumab) (Opdivo) | PD-L1 expression ≥ 1% | + platinum-based chemotherapy | Neoadjuvant, early | High risk of recurrence |
| [Nivolumab](https://oncolabels.com/drugs/nivolumab) (Opdivo) | PD-L1 expression ≥ 1% | + platinum-based chemotherapy | Neoadjuvant, early | Then adjuvant monotherapy after surgery; High risk of recurrence |
| [Atezolizumab](https://oncolabels.com/drugs/atezolizumab) (Tecentriq) | PD-L1 expression on ≥ 50% TC, EGFR/ALK-negative | Monotherapy | Adjuvant, early | Following complete resection and platinum-based chemotherapy; High risk of recurrence Ambiguous in the label (stage): check the SmPC. |
| [Nivolumab](https://oncolabels.com/drugs/nivolumab) (Opdivo) | PD-L1 expression ≥ 1% | Monotherapy | Adjuvant, early | After neoadjuvant nivolumab + platinum-based chemotherapy and surgical resection; High risk of recurrence |
| [Atezolizumab](https://oncolabels.com/drugs/atezolizumab) (Tecentriq) | PD-L1 expression ≥ 50% TC or ≥ 10% IC, EGFR/ALK-negative | Monotherapy | 1st line, metastatic | - |
| [Cemiplimab](https://oncolabels.com/drugs/cemiplimab) (Libtayo) | PD-L1 TPS ≥ 1%, EGFR/ALK/ROS1-negative | + platinum-based chemotherapy | 1st line, advanced | Locally advanced patients must not be candidates for definitive chemoradiation |
| [Cemiplimab](https://oncolabels.com/drugs/cemiplimab) (Libtayo) | PD-L1 TPS ≥ 50%, EGFR/ALK/ROS1-negative | Monotherapy | 1st line, advanced | Locally advanced patients must not be candidates for definitive chemoradiation |
| [Pembrolizumab](https://oncolabels.com/drugs/pembrolizumab) (Keytruda) | PD-L1 TPS ≥ 50%, EGFR/ALK-negative | Monotherapy | 1st line, metastatic | - |
| [Tislelizumab](https://oncolabels.com/drugs/tislelizumab) (Tevimbra) | PD-L1 expression on ≥ 50% of tumour cells, EGFR/ALK-negative | + pemetrexed and platinum-containing chemotherapy | 1st line, advanced | Non-squamous only; For locally advanced disease: not candidates for surgical resection or platinum-based chemoradiation |
| [Durvalumab](https://oncolabels.com/drugs/durvalumab) (Imfinzi) | TPS ≥ 1%, tumours express PD-L1 on ≥ 1% of tumour cells | Monotherapy | Consolidation, locally advanced | After platinum-based chemoradiation therapy without progression |
| [Sugemalimab](https://oncolabels.com/drugs/sugemalimab) (Cejemly) | PD-L1 expression ≥ 1%, EGFR/ALK/ROS1-negative | Monotherapy | Consolidation, locally advanced | After platinum-based chemoradiotherapy without progression |
| [Pembrolizumab](https://oncolabels.com/drugs/pembrolizumab) (Keytruda) | PD-L1 TPS ≥ 1% | Monotherapy | 2nd line, advanced | After at least one prior chemotherapy regimen; prior targeted therapy if EGFR or ALK positive |

### RET fusion

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Selpercatinib](https://oncolabels.com/drugs/selpercatinib) (Retsevmo) | RET fusion | Monotherapy | Advanced | Not previously treated with a RET inhibitor |

### ROS1 fusion

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Crizotinib](https://oncolabels.com/drugs/crizotinib) (Xalkori) | ROS1 fusion | Monotherapy | Advanced | - |
| [Entrectinib](https://oncolabels.com/drugs/entrectinib) (Rozlytrek) | ROS1 fusion | Monotherapy | Advanced | No prior ROS1 inhibitor |
| [Repotrectinib](https://oncolabels.com/drugs/repotrectinib) (Augtyro) | ROS1 fusion | Monotherapy | Advanced | - |

### EGFR negative

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Erlotinib](https://oncolabels.com/drugs/erlotinib) (Tarceva) | EGFR negative | Monotherapy | 2nd line, advanced | After failure of at least one prior chemotherapy regimen; When other treatment options are not considered suitable |

### EGFR/ALK negative

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Durvalumab](https://oncolabels.com/drugs/durvalumab) (Imfinzi) | EGFR/ALK negative | + platinum-based chemotherapy | Neoadjuvant, early | Then adjuvant monotherapy after surgery; High risk of recurrence |
| [Durvalumab](https://oncolabels.com/drugs/durvalumab) (Imfinzi) | EGFR/ALK negative | Monotherapy | Adjuvant, early | After neoadjuvant durvalumab + platinum-based chemotherapy and surgical resection; High risk of recurrence |
| [Atezolizumab](https://oncolabels.com/drugs/atezolizumab) (Tecentriq) | EGFR/ALK-negative | + bevacizumab, paclitaxel and carboplatin | 1st line, metastatic | Non-squamous only |
| [Atezolizumab](https://oncolabels.com/drugs/atezolizumab) (Tecentriq) | EGFR/ALK-negative | + nab-paclitaxel and carboplatin | 1st line, metastatic | Non-squamous only |
| [Durvalumab](https://oncolabels.com/drugs/durvalumab) (Imfinzi) | No sensitising EGFR mutations or ALK positive mutations | + tremelimumab and platinum-based chemotherapy | 1st line, metastatic | - |
| [Ipilimumab](https://oncolabels.com/drugs/ipilimumab) (Yervoy) | No sensitising EGFR mutation or ALK translocation | + nivolumab and 2 cycles of platinum-based chemotherapy | 1st line, metastatic | - |
| [Nivolumab](https://oncolabels.com/drugs/nivolumab) (Opdivo) | No sensitising EGFR mutation or ALK translocation | + ipilimumab and 2 cycles of platinum-based chemotherapy | 1st line, metastatic | - |
| [Pembrolizumab](https://oncolabels.com/drugs/pembrolizumab) (Keytruda) | EGFR/ALK-negative | + pemetrexed and platinum chemotherapy | 1st line, metastatic | Non-squamous only |
| [Tremelimumab](https://oncolabels.com/drugs/tremelimumab) (Imjudo) | No sensitising EGFR mutations or ALK positive mutations | + durvalumab and platinum-based chemotherapy | 1st line, metastatic | - |

### EGFR/ALK/ROS1 negative

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Serplulimab](https://oncolabels.com/drugs/serplulimab) (Hetronifly) | EGFR/ALK/ROS1 negative | + carboplatin and pemetrexed | 1st line, advanced | Non-squamous only; Not candidates for surgery or radiotherapy (if locally advanced) |

### EGFR/ALK/ROS1/RET negative

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Sugemalimab](https://oncolabels.com/drugs/sugemalimab) (Cejemly) | No sensitising EGFR mutations, or ALK, ROS1 or RET genomic tumour aberrations | + platinum-based chemotherapy | 1st line, metastatic | - |

### No biomarker required

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Pembrolizumab](https://oncolabels.com/drugs/pembrolizumab) (Keytruda) | None | + platinum-containing chemotherapy | Neoadjuvant, early | Then adjuvant monotherapy after surgery; High risk of recurrence |
| [Tislelizumab](https://oncolabels.com/drugs/tislelizumab) (Tevimbra) | None | + platinum-containing chemotherapy | Neoadjuvant, early | Then adjuvant monotherapy after surgery; High risk of recurrence |
| [Pembrolizumab](https://oncolabels.com/drugs/pembrolizumab) (Keytruda) | None | Monotherapy | Adjuvant, early | After neoadjuvant pembrolizumab + platinum-containing chemotherapy and surgical resection; High risk of recurrence |
| [Pembrolizumab](https://oncolabels.com/drugs/pembrolizumab) (Keytruda) | None | Monotherapy | Adjuvant | After complete resection and platinum-based chemotherapy; High risk of recurrence |
| [Tislelizumab](https://oncolabels.com/drugs/tislelizumab) (Tevimbra) | None | Monotherapy | Adjuvant, early | After neoadjuvant tislelizumab + platinum-containing chemotherapy and surgical resection; High risk of recurrence |
| [Atezolizumab](https://oncolabels.com/drugs/atezolizumab) (Tecentriq) | None | Monotherapy | 1st line, advanced | Ineligible for platinum-based therapy |
| [Bevacizumab](https://oncolabels.com/drugs/bevacizumab) (Avastin) | None | + platinum-based chemotherapy | 1st line, advanced | Non-squamous only |
| [Pembrolizumab](https://oncolabels.com/drugs/pembrolizumab) (Keytruda) | None | + carboplatin and either paclitaxel or nab-paclitaxel | 1st line, metastatic | Squamous only |
| [Serplulimab](https://oncolabels.com/drugs/serplulimab) (Hetronifly) | None | + carboplatin and nab-paclitaxel | 1st line, advanced | Squamous only |
| [Tislelizumab](https://oncolabels.com/drugs/tislelizumab) (Tevimbra) | None | + carboplatin and paclitaxel or nab-paclitaxel | 1st line, advanced | Squamous only; For locally advanced disease: not candidates for surgical resection or platinum-based chemoradiation |
| [Afatinib](https://oncolabels.com/drugs/afatinib) (Giotrif) | None | Monotherapy | 2nd line, advanced | Squamous only; Progressed on or after platinum-based chemotherapy |
| [Atezolizumab](https://oncolabels.com/drugs/atezolizumab) (Tecentriq) | None | Monotherapy | 2nd line, advanced | After prior chemotherapy; patients with EGFR-mutant or ALK-positive NSCLC should also have received targeted therapies |
| [Nintedanib](https://oncolabels.com/drugs/nintedanib) (Vargatef) | None | + docetaxel | 2nd line, advanced | Adenocarcinoma only; After first-line chemotherapy |
| [Nivolumab](https://oncolabels.com/drugs/nivolumab) (Opdivo) | None | Monotherapy | 2nd line, advanced | After prior chemotherapy |
| [Ramucirumab](https://oncolabels.com/drugs/ramucirumab) (Cyramza) | None | + docetaxel | 2nd line, advanced | After platinum-based chemotherapy |
| [Tislelizumab](https://oncolabels.com/drugs/tislelizumab) (Tevimbra) | None | Monotherapy | 2nd line, advanced | After prior platinum-based therapy; patients with EGFR mutant or ALK positive NSCLC should also have received targeted therapies |

## Tumour-agnostic approvals

Approved for any solid tumour that carries the alteration, wherever the tumour started.

### EpCAM

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Catumaxomab](https://oncolabels.com/drugs/catumaxomab) (Korjuny) | EpCAM-positive | Monotherapy | 2nd line | Malignant ascites; not eligible for further systemic anticancer therapy Ambiguous in the label (tumour site, line of therapy): check the SmPC. |

### HER2

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Trastuzumab deruxtecan](https://oncolabels.com/drugs/trastuzumab-deruxtecan) (Enhertu) | HER2-positive (IHC 3+) | Monotherapy | 2nd line, advanced | After prior treatment; No satisfactory treatment options |

### NTRK fusion

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Entrectinib](https://oncolabels.com/drugs/entrectinib) (Rozlytrek) | NTRK fusion | Monotherapy | Any line | No prior NTRK inhibitor; Older than 1 month; disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity; no satisfactory treatment options |
| [Larotrectinib](https://oncolabels.com/drugs/larotrectinib) (Vitrakvi) | NTRK fusion | Monotherapy | Any line | Locally advanced, metastatic or where surgical resection is likely to result in severe morbidity; no satisfactory treatment options |
| [Repotrectinib](https://oncolabels.com/drugs/repotrectinib) (Augtyro) | NTRK fusion | Monotherapy | Advanced | Prior NTRK inhibitor, or no prior NTRK inhibitor and treatment options not targeting NTRK provide limited clinical benefit or have been exhausted; Aged 12 years and older |

### RET fusion

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Selpercatinib](https://oncolabels.com/drugs/selpercatinib) (Retsevmo) | RET fusion | Monotherapy | Advanced | Treatment options not targeting RET provide limited clinical benefit, or have been exhausted; Aged 2 years and older |

## Label wording

- **Entrectinib** (Rozlytrek), Non-small cell lung cancer, advanced: “Rozlytrek as monotherapy is indicated for the treatment of adult patients with ROS1-positive, advanced non-small cell lung cancer (NSCLC) not previously treated with ROS1 inhibitors.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/rozlytrek-epar-product-information_en.pdf)
- **Pembrolizumab** (Keytruda), Non-small cell lung cancer, neoadjuvant, early: “KEYTRUDA, in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment, is indicated for the treatment of resectable non-small cell lung carcinoma at high risk of recurrence in adults (for selection criteria, see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf)
- **Pembrolizumab** (Keytruda), Non-small cell lung cancer, adjuvant, early: “KEYTRUDA, in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment, is indicated for the treatment of resectable non-small cell lung carcinoma at high risk of recurrence in adults (for selection criteria, see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf)
- **Pembrolizumab** (Keytruda), Non-small cell lung cancer, adjuvant: “KEYTRUDA as monotherapy is indicated for the adjuvant treatment of adults with non-small cell lung carcinoma who are at high risk of recurrence following complete resection and platinum-based chemotherapy (for selection criteria, see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf)
- **Pembrolizumab** (Keytruda), Non-small cell lung cancer, 1st line, metastatic: “KEYTRUDA as monotherapy is indicated for the first-line treatment of metastatic non-small cell lung carcinoma in adults whose tumours express PD-L1 with a ≥ 50% tumour proportion score (TPS) with no EGFR or ALK positive tumour mutations.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf)
- **Pembrolizumab** (Keytruda), Non-small cell lung cancer, 1st line, metastatic: “KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of metastatic non-squamous non-small cell lung carcinoma in adults whose tumours have no EGFR or ALK positive mutations.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf)
- **Pembrolizumab** (Keytruda), Non-small cell lung cancer, 1st line, metastatic: “KEYTRUDA, in combination with carboplatin and either paclitaxel or nab-paclitaxel, is indicated for the first-line treatment of metastatic squamous non-small cell lung carcinoma in adults.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf)
- **Pembrolizumab** (Keytruda), Non-small cell lung cancer, 2nd line, advanced: “KEYTRUDA as monotherapy is indicated for the treatment of locally advanced or metastatic non-small cell lung carcinoma in adults whose tumours express PD-L1 with a ≥ 1% TPS and who have received at least one prior chemotherapy regimen. Patients with EGFR or ALK positive tumour mutations should also have received targeted therapy before receiving KEYTRUDA.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf)
- **Nivolumab** (Opdivo), Non-small cell lung cancer, neoadjuvant, early: “OPDIVO in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have PD-L1 expression ≥ 1% (see section 5.1 for selection criteria).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/opdivo-epar-product-information_en.pdf)
- **Nivolumab** (Opdivo), Non-small cell lung cancer, neoadjuvant, early: “OPDIVO in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by OPDIVO as monotherapy as adjuvant treatment, is indicated for the treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have PD-L1 expression ≥ 1% (see section 5.1 for selection criteria).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/opdivo-epar-product-information_en.pdf)
- **Nivolumab** (Opdivo), Non-small cell lung cancer, adjuvant, early: “OPDIVO in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by OPDIVO as monotherapy as adjuvant treatment, is indicated for the treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have PD-L1 expression ≥ 1% (see section 5.1 for selection criteria).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/opdivo-epar-product-information_en.pdf)
- **Nivolumab** (Opdivo), Non-small cell lung cancer, 1st line, metastatic: “OPDIVO in combination with ipilimumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising EGFR mutation or ALK translocation.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/opdivo-epar-product-information_en.pdf)
- **Nivolumab** (Opdivo), Non-small cell lung cancer, 2nd line, advanced: “OPDIVO as monotherapy is indicated for the treatment of locally advanced or metastatic non-small cell lung cancer after prior chemotherapy in adults.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/opdivo-epar-product-information_en.pdf)
- **Sugemalimab** (Cejemly), Non-small cell lung cancer, 1st line, metastatic: “Cejemly in combination with platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic non-small-cell lung cancer (NSCLC) with no sensitising EGFR mutations, or ALK, ROS1 or RET genomic tumour aberrations.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/cejemly-epar-product-information_en.pdf)
- **Sugemalimab** (Cejemly), Non-small cell lung cancer, consolidation, locally advanced: “Cejemly as monotherapy is indicated for the treatment of unresectable stage III NSCLC with no sensitising EGFR mutations, or ALK, ROS1 genomic tumour aberrations in adults whose tumours express PD-L1 on ≥ 1% of tumour cells and whose disease has not progressed following platinum-based chemoradiotherapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/cejemly-epar-product-information_en.pdf)
- **Trastuzumab deruxtecan** (Enhertu), Non-small cell lung cancer, 2nd line, advanced: “Enhertu as monotherapy is indicated for the treatment of adult patients with advanced NSCLC whose tumours have an activating HER2 (ERBB2) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/enhertu-epar-product-information_en.pdf)
- **Dacomitinib** (Vizimpro), Non-small cell lung cancer, 1st line, advanced: “Vizimpro, as monotherapy, is indicated for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR)-activating mutations.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/vizimpro-epar-product-information_en.pdf)
- **Gefitinib** (Iressa), Non-small cell lung cancer, advanced: “IRESSA is indicated as monotherapy for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating mutations of EGFR-TK (see section 4.4).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/iressa-epar-product-information_en.pdf)
- **Durvalumab** (Imfinzi), Non-small cell lung cancer, neoadjuvant, early: “IMFINZI in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by IMFINZI as monotherapy as adjuvant treatment, is indicated for the treatment of adults with resectable NSCLC at high risk of recurrence and no EGFR mutations or ALK rearrangements (for selection criteria, see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/imfinzi-epar-product-information_en.pdf)
- **Durvalumab** (Imfinzi), Non-small cell lung cancer, adjuvant, early: “IMFINZI in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by IMFINZI as monotherapy as adjuvant treatment, is indicated for the treatment of adults with resectable NSCLC at high risk of recurrence and no EGFR mutations or ALK rearrangements (for selection criteria, see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/imfinzi-epar-product-information_en.pdf)
- **Durvalumab** (Imfinzi), Non-small cell lung cancer, consolidation, locally advanced: “IMFINZI as monotherapy is indicated for the treatment of locally advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 on ≥ 1% of tumour cells and whose disease has not progressed following platinum-based chemoradiation therapy (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/imfinzi-epar-product-information_en.pdf)
- **Durvalumab** (Imfinzi), Non-small cell lung cancer, 1st line, metastatic: “IMFINZI in combination with tremelimumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic NSCLC with no sensitising EGFR mutations or ALK positive mutations.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/imfinzi-epar-product-information_en.pdf)
- **Lazertinib** (Lazcluze), Non-small cell lung cancer, 1st line, advanced: “Lazcluze in combination with amivantamab is indicated for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 L858R substitution mutations.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/lazcluze-epar-product-information_en.pdf)
- **Nintedanib** (Vargatef), Non-small cell lung cancer, 2nd line, advanced: “Vargatef is indicated in combination with docetaxel for the treatment of adult patients with locally advanced, metastatic or locally recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumour histology after first-line chemotherapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/vargatef-epar-product-information_en.pdf)
- **Serplulimab** (Hetronifly), Non-small cell lung cancer, 1st line, advanced: “HETRONIFLY in combination with carboplatin and pemetrexed is indicated for the first-line treatment of adult non-squamous NSCLC patients with no EGFR, ALK or ROS1 positive mutations and who have:
 locally advanced NSCLC who are not candidates for surgery or radiotherapy, or  metastatic NSCLC.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/hetronifly-epar-product-information_en.pdf)
- **Serplulimab** (Hetronifly), Non-small cell lung cancer, 1st line, advanced: “HETRONIFLY in combination with carboplatin and nab-paclitaxel is indicated for the first-line treatment of adult patients with unresectable, locally advanced or metastatic squamous non-small cell lung carcinoma.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/hetronifly-epar-product-information_en.pdf)
- **Bevacizumab** (Avastin), Non-small cell lung cancer, 1st line, advanced: “Bevacizumab, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/avastin-epar-product-information_en.pdf)
- **Bevacizumab** (Avastin), Non-small cell lung cancer, 1st line, advanced: “Bevacizumab, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with Epidermal Growth Factor Receptor (EGFR) activating mutations (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/avastin-epar-product-information_en.pdf)
- **Tepotinib** (Tepmetko), Non-small cell lung cancer, 2nd line, advanced: “TEPMETKO as monotherapy is indicated for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harbouring alterations leading to mesenchymal-epithelial transition factor gene exon 14 (METex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tepmetko-epar-product-information_en.pdf)
- **Crizotinib** (Xalkori), Non-small cell lung cancer, 1st line, advanced: “The first-line treatment of adults with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC)” [SmPC](https://www.ema.europa.eu/en/documents/product-information/xalkori-epar-product-information_en.pdf)
- **Crizotinib** (Xalkori), Non-small cell lung cancer, 2nd line, advanced: “The treatment of adults with previously treated anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC)” [SmPC](https://www.ema.europa.eu/en/documents/product-information/xalkori-epar-product-information_en.pdf)
- **Crizotinib** (Xalkori), Non-small cell lung cancer, advanced: “The treatment of adults with ROS1-positive advanced non-small cell lung cancer (NSCLC)” [SmPC](https://www.ema.europa.eu/en/documents/product-information/xalkori-epar-product-information_en.pdf)
- **Tislelizumab** (Tevimbra), Non-small cell lung cancer, neoadjuvant, early: “Tevimbra, in combination with platinum-containing chemotherapy as neoadjuvant treatment and then continued as monotherapy as adjuvant treatment, is indicated for the treatment of adult patients with resectable NSCLC at high risk of recurrence (for selection criteria, see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tevimbra-epar-product-information_en.pdf)
- **Tislelizumab** (Tevimbra), Non-small cell lung cancer, adjuvant, early: “Tevimbra, in combination with platinum-containing chemotherapy as neoadjuvant treatment and then continued as monotherapy as adjuvant treatment, is indicated for the treatment of adult patients with resectable NSCLC at high risk of recurrence (for selection criteria, see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tevimbra-epar-product-information_en.pdf)
- **Tislelizumab** (Tevimbra), Non-small cell lung cancer, 1st line, advanced: “Tevimbra, in combination with pemetrexed and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with non-squamous NSCLC whose tumours have PD-L1 expression on ≥50% of tumour cells with no EGFR or ALK positive mutations and who have: • locally advanced NSCLC and are not candidates for surgical resection or platinum-based chemoradiation, or • metastatic NSCLC.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tevimbra-epar-product-information_en.pdf)
- **Tislelizumab** (Tevimbra), Non-small cell lung cancer, 1st line, advanced: “Tevimbra, in combination with carboplatin and either paclitaxel or nab-paclitaxel, is indicated for the first-line treatment of adult patients with squamous NSCLC who have: • locally advanced NSCLC and are not candidates for surgical resection or platinum-based chemoradiation, or • metastatic NSCLC.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tevimbra-epar-product-information_en.pdf)
- **Tislelizumab** (Tevimbra), Non-small cell lung cancer, 2nd line, advanced: “Tevimbra as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic NSCLC after prior platinum-based therapy. Patients with EGFR mutant or ALK positive NSCLC should also have received targeted therapies before receiving tislelizumab.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tevimbra-epar-product-information_en.pdf)
- **Osimertinib** (Tagrisso), Non-small cell lung cancer, adjuvant: “the adjuvant treatment after complete tumour resection in adult patients with stage IB-IIIA non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tagrisso-epar-product-information_en.pdf)
- **Osimertinib** (Tagrisso), Non-small cell lung cancer, consolidation, locally advanced: “the treatment of adult patients with locally advanced, unresectable NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations and whose disease has not progressed during or following platinum-based chemoradiation therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tagrisso-epar-product-information_en.pdf)
- **Osimertinib** (Tagrisso), Non-small cell lung cancer, 1st line, advanced: “the first-line treatment of adult patients with locally advanced or metastatic NSCLC with activating EGFR mutations.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tagrisso-epar-product-information_en.pdf)
- **Osimertinib** (Tagrisso), Non-small cell lung cancer, advanced: “the treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tagrisso-epar-product-information_en.pdf)
- **Osimertinib** (Tagrisso), Non-small cell lung cancer, 1st line, advanced: “pemetrexed and platinum-based chemotherapy for the first-line treatment of adult patients with advanced NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tagrisso-epar-product-information_en.pdf)
- **Adagrasib** (Krazati), Non-small cell lung cancer, 2nd line, advanced: “KRAZATI as monotherapy is indicated for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutation and disease progression after at least one prior systemic therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/krazati-epar-product-information_en.pdf)
- **Sotorasib** (Lumykras), Non-small cell lung cancer, 2nd line, advanced: “LUMYKRAS as monotherapy is indicated for the treatment of adults with advanced non-small cell lung cancer (NSCLC) with KRAS G12C-mutation and who have progressed after at least one prior line of systemic therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/lumykras-epar-product-information_en.pdf)
- **Encorafenib** (Braftovi), Non-small cell lung cancer, advanced: “Encorafenib in combination with binimetinib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600E mutation.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/braftovi-epar-product-information_en.pdf)
- **Atezolizumab** (Tecentriq), Non-small cell lung cancer, adjuvant, early: “Tecentriq as monotherapy is indicated as adjuvant treatment following complete resection and platinum-based chemotherapy for adult patients with NSCLC with a high risk of recurrence whose tumours have PD-L1 expression on ≥ 50% of tumour cells (TC) and who do not have EGFR-mutant or ALK-positive NSCLC (see section 5.1 for selection criteria).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tecentriq-epar-product-information_en.pdf)
- **Atezolizumab** (Tecentriq), Non-small cell lung cancer, 1st line, metastatic: “Tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous NSCLC. In patients with EGFR-mutant or ALK-positive NSCLC, Tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated only after failure of appropriate targeted therapies (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tecentriq-epar-product-information_en.pdf)
- **Atezolizumab** (Tecentriq), Non-small cell lung cancer, 2nd line, metastatic: “In patients with EGFR-mutant or ALK-positive NSCLC, Tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated only after failure of appropriate targeted therapies (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tecentriq-epar-product-information_en.pdf)
- **Atezolizumab** (Tecentriq), Non-small cell lung cancer, 2nd line, metastatic: “In patients with EGFR-mutant or ALK-positive NSCLC, Tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated only after failure of appropriate targeted therapies (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tecentriq-epar-product-information_en.pdf)
- **Atezolizumab** (Tecentriq), Non-small cell lung cancer, 1st line, metastatic: “Tecentriq, in combination with nab-paclitaxel and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous NSCLC who do not have EGFR-mutant or ALK-positive NSCLC (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tecentriq-epar-product-information_en.pdf)
- **Atezolizumab** (Tecentriq), Non-small cell lung cancer, 1st line, metastatic: “Tecentriq as monotherapy is indicated for the first-line treatment of adult patients with metastatic NSCLC whose tumours have a PD-L1 expression ≥ 50% TC or ≥ 10% tumour-infiltrating immune cells (IC) and who do not have EGFR-mutant or ALK-positive NSCLC (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tecentriq-epar-product-information_en.pdf)
- **Atezolizumab** (Tecentriq), Non-small cell lung cancer, 1st line, advanced: “Tecentriq as monotherapy is indicated for the first-line treatment of adult patients with advanced NSCLC who are ineligible for platinum-based therapy (see section 5.1 for selection criteria).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tecentriq-epar-product-information_en.pdf)
- **Atezolizumab** (Tecentriq), Non-small cell lung cancer, 2nd line, advanced: “Tecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic NSCLC after prior chemotherapy. Patients with EGFR-mutant or ALK-positive NSCLC should also have received targeted therapies before receiving Tecentriq (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tecentriq-epar-product-information_en.pdf)
- **Amivantamab** (Rybrevant), Non-small cell lung cancer, 1st line, advanced: “in combination with lazertinib for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with EGFR Exon 19 deletions or Exon 21 L858R substitution mutations.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/rybrevant-epar-product-information_en.pdf)
- **Amivantamab** (Rybrevant), Non-small cell lung cancer, 2nd line, advanced: “in combination with carboplatin and pemetrexed for the treatment of adult patients with advanced NSCLC with EGFR Exon 19 deletions or Exon 21 L858R substitution mutations after failure of prior therapy including an EGFR tyrosine kinase inhibitor (TKI).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/rybrevant-epar-product-information_en.pdf)
- **Amivantamab** (Rybrevant), Non-small cell lung cancer, 1st line, advanced: “in combination with carboplatin and pemetrexed for the first-line treatment of adult patients with advanced NSCLC with activating EGFR Exon 20 insertion mutations.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/rybrevant-epar-product-information_en.pdf)
- **Amivantamab** (Rybrevant), Non-small cell lung cancer, 2nd line, advanced: “as monotherapy for treatment of adult patients with advanced NSCLC with activating EGFR Exon 20 insertion mutations, after failure of platinum-based therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/rybrevant-epar-product-information_en.pdf)
- **Selpercatinib** (Retsevmo), Non-small cell lung cancer, advanced: “advanced RET fusion-positive non-small cell lung cancer (NSCLC) not previously treated with a RET inhibitor.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/retsevmo-epar-product-information_en.pdf)
- **Lorlatinib** (Lorviqua), Non-small cell lung cancer, advanced: “Lorviqua as monotherapy is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously not treated with an ALK inhibitor.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/lorviqua-epar-product-information_en.pdf)
- **Lorlatinib** (Lorviqua), Non-small cell lung cancer, 2nd line, advanced: “Lorviqua as monotherapy is indicated for the treatment of adult patients with ALK-positive advanced NSCLC whose disease has progressed after:
• alectinib or ceritinib as the first ALK tyrosine kinase inhibitor (TKI) therapy; or
• crizotinib and at least one other ALK TKI.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/lorviqua-epar-product-information_en.pdf)
- **Ipilimumab** (Yervoy), Non-small cell lung cancer, 1st line, metastatic: “YERVOY in combination with nivolumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising EGFR mutation or ALK translocation.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/yervoy-epar-product-information_en.pdf)
- **Alectinib** (Alecensa), Non-small cell lung cancer, adjuvant: “Alecensa as monotherapy is indicated as adjuvant treatment following complete tumour resection for adult patients with ALK-positive NSCLC at high risk of recurrence (see section 5.1 for selection criteria).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/alecensa-epar-product-information_en.pdf)
- **Alectinib** (Alecensa), Non-small cell lung cancer, 1st line, advanced: “Alecensa as monotherapy is indicated for the first-line treatment of adult patients with ALK-positive advanced NSCLC.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/alecensa-epar-product-information_en.pdf)
- **Alectinib** (Alecensa), Non-small cell lung cancer, 2nd line, advanced: “Alecensa as monotherapy is indicated for the treatment of adult patients with ALK-positive advanced NSCLC previously treated with crizotinib.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/alecensa-epar-product-information_en.pdf)
- **Trametinib** (Mekinist), Non-small cell lung cancer, advanced: “Trametinib in combination with dabrafenib is indicated for the treatment of adults with advanced non-small cell lung cancer with a BRAF V600 mutation.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/mekinist-epar-product-information_en.pdf)
- **Dabrafenib** (Tafinlar), Non-small cell lung cancer, advanced: “Dabrafenib in combination with trametinib is indicated for the treatment of adults with advanced non-small cell lung cancer with a BRAF V600 mutation.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tafinlar-epar-product-information_en.pdf)
- **Afatinib** (Giotrif), Non-small cell lung cancer, advanced: “Epidermal Growth Factor Receptor (EGFR) TKI-naïve adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutation(s);” [SmPC](https://www.ema.europa.eu/en/documents/product-information/giotrif-epar-product-information_en.pdf)
- **Afatinib** (Giotrif), Non-small cell lung cancer, 2nd line, advanced: “Adult patients with locally advanced or metastatic NSCLC of squamous histology progressing on or after platinum-based chemotherapy (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/giotrif-epar-product-information_en.pdf)
- **Tremelimumab** (Imjudo), Non-small cell lung cancer, 1st line, metastatic: “IMJUDO in combination with durvalumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic non-small cell lung cancer (NSCLC) with no sensitising EGFR mutations or ALK positive mutations.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/imjudo-epar-product-information_en.pdf)
- **Ceritinib** (Zykadia), Non-small cell lung cancer, 1st line, advanced: “Zykadia as monotherapy is indicated for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/zykadia-epar-product-information_en.pdf)
- **Ceritinib** (Zykadia), Non-small cell lung cancer, 2nd line, advanced: “Zykadia as monotherapy is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/zykadia-epar-product-information_en.pdf)
- **Cemiplimab** (Libtayo), Non-small cell lung cancer, 1st line, advanced: “LIBTAYO as monotherapy is indicated for the first-line treatment of adult patients with non-small cell lung cancer (NSCLC) expressing PD-L1 (in ≥ 50% tumour cells), with no EGFR, ALK or ROS1 aberrations” [SmPC](https://www.ema.europa.eu/en/documents/product-information/libtayo-epar-product-information_en.pdf)
- **Cemiplimab** (Libtayo), Non-small cell lung cancer, 1st line, advanced: “LIBTAYO in combination with platinum-based chemotherapy is indicated for the first‐line treatment of adult patients with NSCLC expressing PD-L1 (in ≥ 1% of tumour cells), with no EGFR, ALK or ROS1 aberrations” [SmPC](https://www.ema.europa.eu/en/documents/product-information/libtayo-epar-product-information_en.pdf)
- **Ramucirumab** (Cyramza), Non-small cell lung cancer, 1st line, metastatic: “Cyramza in combination with erlotinib is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer with activating epidermal growth factor receptor (EGFR) mutations (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/cyramza-epar-product-information_en.pdf)
- **Ramucirumab** (Cyramza), Non-small cell lung cancer, 2nd line, advanced: “Cyramza in combination with docetaxel is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with disease progression after platinum-based chemotherapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/cyramza-epar-product-information_en.pdf)
- **Binimetinib** (Mektovi), Non-small cell lung cancer, advanced: “Binimetinib in combination with encorafenib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600E mutation.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/mektovi-epar-product-information_en.pdf)
- **Capmatinib** (Tabrecta), Non-small cell lung cancer, 2nd line, advanced: “Tabrecta as monotherapy is indicated for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harbouring alterations leading to mesenchymal-epithelial transition factor gene exon 14 (METex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tabrecta-epar-product-information_en.pdf)
- **Brigatinib** (Alunbrig), Non-small cell lung cancer, advanced: “Alunbrig is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously not treated with an ALK inhibitor.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/alunbrig-epar-product-information_en.pdf)
- **Brigatinib** (Alunbrig), Non-small cell lung cancer, 2nd line, advanced: “Alunbrig is indicated as monotherapy for the treatment of adult patients with ALK-positive advanced NSCLC previously treated with crizotinib.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/alunbrig-epar-product-information_en.pdf)
- **Erlotinib** (Tarceva), Non-small cell lung cancer, 1st line, advanced: “Tarceva is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR activating mutations.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tarceva-epar-product-information_en.pdf)
- **Erlotinib** (Tarceva), Non-small cell lung cancer, maintenance, advanced: “Tarceva is also indicated for switch maintenance treatment in patients with locally advanced or metastatic NSCLC with EGFR activating mutations and stable disease after first-line chemotherapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tarceva-epar-product-information_en.pdf)
- **Erlotinib** (Tarceva), Non-small cell lung cancer, 2nd line, advanced: “Tarceva is also indicated for the treatment of patients with locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tarceva-epar-product-information_en.pdf)
- **Erlotinib** (Tarceva), Non-small cell lung cancer, 2nd line, advanced: “In patients with tumours without EGFR activating mutations, Tarceva is indicated when other treatment options are not considered suitable.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tarceva-epar-product-information_en.pdf)
- **Repotrectinib** (Augtyro), Non-small cell lung cancer, advanced: “AUGTYRO as monotherapy is indicated for the treatment of adult patients with ROS1-positive advanced non-small cell lung cancer (NSCLC).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/augtyro-epar-product-information_en.pdf)

Source: section 4.1 of each summary of product characteristics (SmPC), EMA data as of 5 Nov 2026. AI models structured these entries and no person has checked them yet. oncolabels is a non-commercial reference for education and research and gives no medical advice; the current SmPC takes precedence.

Data under CC BY 4.0: credit oncolabels and the European Medicines Agency. Page: https://oncolabels.com/tumours/non-small-cell-lung-cancer