# Small cell lung cancer

The EU has approved 7 indications of 6 drugs in small cell lung cancer. None of them needs a biomarker result. 6 tumour-agnostic approvals also apply when the tumour carries the alteration.

## Approved indications

### No biomarker required

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Atezolizumab](https://oncolabels.com/drugs/atezolizumab) (Tecentriq) | None | + carboplatin and etoposide | 1st line, advanced | - |
| [Durvalumab](https://oncolabels.com/drugs/durvalumab) (Imfinzi) | None | + etoposide and either carboplatin or cisplatin | 1st line, advanced | - |
| [Serplulimab](https://oncolabels.com/drugs/serplulimab) (Hetronifly) | None | + carboplatin and etoposide | 1st line, advanced | - |
| [Tislelizumab](https://oncolabels.com/drugs/tislelizumab) (Tevimbra) | None | + etoposide and platinum chemotherapy | 1st line, advanced | - |
| [Lurbinectedin](https://oncolabels.com/drugs/lurbinectedin) (Zepzelca) | None | + atezolizumab | Maintenance, advanced | After first-line induction therapy with atezolizumab, carboplatin and etoposide without disease progression |
| [Durvalumab](https://oncolabels.com/drugs/durvalumab) (Imfinzi) | None | Monotherapy | Consolidation, locally advanced | After platinum-based chemoradiation therapy without progression |
| [Tarlatamab](https://oncolabels.com/drugs/tarlatamab) (Imdylltra) | None | Monotherapy | 2nd line, advanced | Disease progression on or after first-line treatment with platinum-based chemotherapy; Who require systemic therapy |

## 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

- **Durvalumab** (Imfinzi), Small cell lung cancer, consolidation, locally advanced: “IMFINZI as monotherapy is indicated for the treatment of adults with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following platinum-based chemoradiation therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/imfinzi-epar-product-information_en.pdf)
- **Durvalumab** (Imfinzi), Small cell lung cancer, 1st line, advanced: “IMFINZI in combination with etoposide and either carboplatin or cisplatin is indicated for the first-line treatment of adults with extensive-stage small cell lung cancer (ES-SCLC).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/imfinzi-epar-product-information_en.pdf)
- **Serplulimab** (Hetronifly), Small cell lung cancer, 1st line, advanced: “HETRONIFLY in combination with carboplatin and etoposide is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/hetronifly-epar-product-information_en.pdf)
- **Tislelizumab** (Tevimbra), Small cell lung cancer, 1st line, advanced: “Tevimbra, in combination with etoposide and platinum chemotherapy, is indicated for the first-line treatment of adult patients with extensive-stage SCLC.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tevimbra-epar-product-information_en.pdf)
- **Atezolizumab** (Tecentriq), Small cell lung cancer, 1st line, advanced: “Tecentriq, in combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tecentriq-epar-product-information_en.pdf)
- **Tarlatamab** (Imdylltra), Small cell lung cancer, 2nd line, advanced: “IMDYLLTRA is indicated as monotherapy for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC), who require systemic therapy following disease progression on or after first-line treatment with platinum-based chemotherapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/imdylltra-epar-product-information_en.pdf)
- **Lurbinectedin** (Zepzelca), Small cell lung cancer, maintenance, advanced: “ZEPZELCA, in combination with atezolizumab, is indicated for the maintenance treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first-line induction therapy with atezolizumab, carboplatin and etoposide.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/zepzelca-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/small-cell-lung-cancer
