A Phase III, Open-Label Study of Maintenance Lurbinectedin in Combination With Atezolizumab Compared With Atezolizumab in Participants With Extensive-Stage Small-Cell Lung Cancer

Condition(s) studied

Investigational drug(s) / intervention(s)

Atezolizumab: Atezolizumab will be administered intravenously at a fixed dose of 1200 mg on Day 1 of each 21-day cycle for 4 cycles in the induction phase. Atezolizumab will be administered intravenously at a fixed dose of 1200 mg on Day 1 of each 21-day cycle in the maintenance phase.

Lurbinectedin: Lurbinectedin 3.2 mg/m² will be administered intravenously on Day 1 of each 21-day cycle in the maintenance phase.

Carboplatin: Carboplatin will be administered according to the standard of care treatment for 4 cycles in the induction phase.

Etoposide: Etoposide will be administered according to the standard of care treatment for 4 cycles in the induction phase.

Study summary

Study GO43104 is a Phase III, randomized, open-label, multicenter study of lurbinectedin in combination with atezolizumab compared with atezolizumab alone administered as maintenance therapy in participants with extensive-stage small-cell lung cancer (ES-SCLC) after first-line induction therapy with carboplatin, etoposide, and atezolizumab. The study consists of 2 phases: an induction phase and a maintenance phase. Participants need to have an ongoing response or stable disease per the Response Evaluation Criteria in Solid Tumor (RECIST) v1.1 criteria after completion of 4 cycles of carboplatin, etoposide, and atezolizumab induction treatment in order to be considered for eligibility screening for the maintenance phase. Eligible participants will be randomized in a 1:1 ratio to receive either lurbinectedin plus atezolizumab or atezolizumab in the maintenance phase.

Eligibility

Primary outcome measure(s)

• Randomized Phase: Independent Review Facility (IRF) - Assessed Progression Free Survival (PFS) — Up to 26 months
  PFS was defined as the time from randomization to the date of first documented PD as determined by the IRF according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or death, whichever occurs first. PD was defined as appearance of a new lesion(s), unequivocal progression in non-target lesion(s) or at least a 20% increase in the sum of diameters (SOD) of target lesions, taking as reference the smallest sum on the study including baseline (nadir). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimetres (mm).
• Randomized Phase: Overall Survival (OS) — Up to 26 months
  OS was defined as the time from randomization to the date of death from any cause.

Trial sites (93)

+ 53 more sites — see the full list on the official registry below.

On this site

More Hoffmann-La Roche trials in the UK

Other trials for the same condition