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Bending the Curve Trial by Trial
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Lurbinectedin as second-line treatment for patients with small-cell lung cancer: a single-arm, open-label, phase 2 basket trial

Phase 2N = 105NCT02454972

Population
Adults with small-cell lung cancer pre-treated with one previous chemotherapy-containing line (the abstract's background refers to failure of platinum-based chemotherapy), ECOG performance status 2 or lower, measurable disease, no brain metastasis
Design
Single-arm, open-label phase 2 basket trial at 26 hospitals in six European countries and the USA; lurbinectedin 3.2 mg/m2 as a 1-hour intravenous infusion every 3 weeks until progression or unacceptable toxicity. Primary outcome: proportion with an overall response (RECIST 1.1) assessed by the investigators. The registry record (345 enrolled) covers all basket tumour types; N=105 is the small-cell lung cancer cohort in the paper.
Primary endpoint
ORR
Arms
  • Lurbinectedin (experimental, n = 105): Lurbinectedin 3.2 mg/m2 intravenously every 3 weeks
People
Trigo J, senior author Paz-Ares L
Show the numbers
Results reported for Lurbinectedin as second-line treatment for patients with small-cell lung cancer: a single-arm, open-label, phase 2 basket trial
EndpointAnalysisLurbinectedinControlEffect
ORRAll treated patientsInvestigator assessment, RECIST 1.1primarymedian follow-up 17.1 monthsTrigo 202035.2% (26.2–45.2%)—37 of 105 patients responded. Grade 3-4 neutropenia in 46% and leucopenia in 29%; serious treatment-related adverse events in 10%; no treatment-related deaths.
Results reported for Lurbinectedin as second-line treatment for patients with small-cell lung cancer: a single-arm, open-label, phase 2 basket trial
EndpointAnalysisLurbinectedinControlEffect
ORRAll treated patientsInvestigator assessment, RECIST 1.1primarymedian follow-up 17.1 monthsTrigo 202035.2% (26.2–45.2%)—37 of 105 patients responded. Grade 3-4 neutropenia in 46% and leucopenia in 29%; serious treatment-related adverse events in 10%; no treatment-related deaths.
Primary publication: Trigo J, Subbiah V, Besse B, Moreno V, López R, Sala MA, et al. Lurbinectedin as second-line treatment for patients with small-cell lung cancer: a single-arm, open-label, phase 2 basket trial. Lancet Oncol. 2020;21(5):645-654. PubMedDOI

Appears in

Sources

  1. Trigo J, Subbiah V, Besse B, Moreno V, López R, Sala MA, et al. Lurbinectedin as second-line treatment for patients with small-cell lung cancer: a single-arm, open-label, phase 2 basket trial. Lancet Oncol. 2020;21(5):645-654.

    PubMedDOI