# EGFR in non-small cell lung cancer

31 EU-approved indications in non-small cell lung cancer need a EGFR result: pembrolizumab (1st line, metastatic), nivolumab (1st line, metastatic), sugemalimab (1st line, metastatic), dacomitinib (1st line, advanced), gefitinib (advanced), durvalumab (neoadjuvant, early), durvalumab (adjuvant, early), durvalumab (1st line, metastatic), lazertinib (1st line, advanced), serplulimab (1st line, advanced), bevacizumab (1st line, advanced), osimertinib (adjuvant), osimertinib (consolidation, locally advanced), osimertinib (1st line, advanced), osimertinib (advanced), osimertinib (1st line, advanced), atezolizumab (1st line, metastatic), atezolizumab (2nd line, metastatic), atezolizumab (1st line, metastatic), amivantamab (1st line, advanced), amivantamab (2nd line, advanced), amivantamab (1st line, advanced), amivantamab (2nd line, advanced), ipilimumab (1st line, metastatic), afatinib (advanced), tremelimumab (1st line, metastatic), ramucirumab (1st line, metastatic), erlotinib (1st line, advanced), erlotinib (maintenance, advanced), erlotinib (2nd line, advanced) and erlotinib (2nd line, advanced).

## Approved indications

### 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 | - |

### 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 | - |

## Label wording

- **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)
- **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)
- **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)
- **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, 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)
- **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)
- **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)
- **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)
- **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, 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)
- **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)
- **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)
- **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)
- **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)
- **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)
- **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)

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/egfr