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A single-arm study of 105 patients that gave relapsed small-cell lung cancer its first new drug in decades, on a response rate rather than a survival benefit.
Small-cell lung cancer relapsing after platinum and etoposide had one approved option, topotecan, with a response rate near 15 percent and heavy myelosuppression. Lurbinectedin binds the minor groove of DNA at CG-rich promoter regions and blocks oncogenic transcription; it also depletes tumour-associated macrophages. The basket study recruited from 26 hospitals in six European countries and the United States between October 2015 and January 2019 and treated 105 patients with one previous chemotherapy line at 3.2 mg/m2 every three weeks.
Investigator-assessed objective response was 35.2 percent (95 percent confidence interval 26.2 to 45.2) at a median follow-up of 17.1 months. Grade 3 to 4 events were haematological: neutropenia 46 percent, leucopenia 29 percent, anaemia 9 percent, thrombocytopenia 7 percent. Serious treatment-related events occurred in 10 percent.
The FDA granted accelerated approval in 2020. The confirmatory trial, ATLANTIS, which tested lurbinectedin with doxorubicin against topotecan or CAV, missed its overall survival endpoint, so the approval rested on the single-arm data for years; the randomised evidence came from IMforte, on which the FDA approved lurbinectedin with atezolizumab for maintenance treatment of extensive-stage disease on 2 October 2025. Lurbinectedin has no marketing authorisation in the United Kingdom and no NICE appraisal, so it is not available on the NHS.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
105 treated.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Objective response rate (investigator assessed)primary | Lurbinectedin 3.2 mg/m2 | 105 | 35.2% | - | - | link |
Shares IMforte, Lurbinectedin, Extensive-stage small-cell lung cancer, Small-cell lung cancer.
Shares PharmaMar, Lurbinectedin, Cytotoxic chemotherapy.
Shares Lurbinectedin, Topotecan, Small-cell lung cancer, Cytotoxic chemotherapy.
Shares Lurbinectedin, Extensive-stage small-cell lung cancer, Small-cell lung cancer, Cytotoxic chemotherapy.
Shares Lurbinectedin, Topotecan, Extensive-stage small-cell lung cancer, Small-cell lung cancer.
Shares Lurbinectedin, Topotecan, Extensive-stage small-cell lung cancer, Small-cell lung cancer.
Shares A Phase 2 Study of Tarlatamab in Patients With Small Cell Lung Cancer (SCLC), Extensive-stage small-cell lung cancer, Lung cancer (all types), Small-cell lung cancer.
Shares A Phase 2 Study of Tarlatamab in Patients With Small Cell Lung Cancer (SCLC), Topotecan, Extensive-stage small-cell lung cancer, Lung cancer (all types).