Phase 3 Global Study Comparing Sacituzumab Govitecan to Standard Treatments in People With Previously Treated Extensive Stage Small Cell Lung Cancer

What this Trial Is About

Researchers are evaluating the study drug sacituzumab govitecan SG Trodelvy GS-0132 IMMU 132 compared to standard of care SOC treatments in participants who have previously been treated for extensive stage small cell lung cancer ES-SCLC. The main goal is to compare how SG versus SOC affects overall survival OS in this population. This is a global, multicenter, randomized, open-label, phase 3 clinical trial focusing on treatment outcomes for ES-SCLC. Participants are randomly assigned to one of two groups. Treatment Group A receives sacituzumab govitecan intravenously at 10 mgkg on Days 1 and 8 of a 21-day cycle, continuing until disease progression, death, unacceptable toxicity, or other reasons for stopping treatment. Treatment Group B receives investigator-selected standard care options within a 21-day cycle, including topotecan given daily on Days 1 through 5, lurbinectedin as an intravenous infusion on Day 1 where approved, or in Japan, amrubicin daily on Days 1 through 3. Treatment continues under the same conditions as Group A. Participants will undergo regular assessments including imaging scans to measure disease status, laboratory tests, and monitoring for side effects. Researchers will evaluate overall survival for up to 4.5 years and secondary outcomes such as progression-free survival, response rates, duration of response, and effects on symptoms like shortness of breath and physical functioning. Safety will be tracked through adverse event reporting and laboratory abnormalities throughout the study duration.

Study of Sacituzumab Govitecan Versus Standard of Care in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer