- Study of Sacituzumab Govitecan Versus Standard of Care in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer — Recruiting • Phase III • Oncology • NCT06801834.
- Intervention being tested: Sacituzumab govitecan (an antibody-drug conjugate targeting Trop-2) compared against standard of care chemotherapy in patients with previously treated extensive-stage small cell lung cancer.
- Patient eligibility overview: Adults with extensive-stage SCLC who have received at least one prior line of systemic treatment and have measurable disease; patients must have adequate organ function and performance status.
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
The goal of this clinical study is to learn more about the study drug sacituzumab govitecan (SG; Trodelvy®; GS-0132; IMMU 132), versus standard of care (SOC) in participants with previously treated extensive stage small cell lung cancer (ES-SCLC). The primary objectives of this study are to compare the effect of SG to SOC on overall survival (OS).
- Key Inclusion Criteria: * Histologically confirmed diagnosis of SCLC. * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. * Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) as assessed by investigator per RECIST v1.1 criteria. * Documentation of radiological disease progression after 1 prior line of platinum-containing chemotherapy (defined as at least 2 cycles of treatment) with or without therapy directed against programmed cell death protein 1 (PD-1) or programmed cell death ligand 1 (PD-L1; PD-1 and PD-L1 are hereafter referred to as PD-(L)1) for ES-SCLC. * Individuals treated with a platinum-based therapy for prior limited stage small cell lung cancer will be counted as 1 prior line of platinum-containing chemotherapy if the disease has progressed within 30 to 180 days from last dose of platinum treatment. * If the investigator believes a participant may benefit from platinum rechallenge it can be considered per investigator discretion and local SOC; however, participants with platinum rechallenge may not participate in the study. * If the investigator believes a participant may benefit from tarlatamab treatment, it can be considered per investigator discretion and local SOC and such participants may participate in the study following tarlatamab treatment.…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.