Study of Sacituzumab Govitecan Versus Standard of Care in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer
A Global, Multicenter, Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Standard of Care (SOC) in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer (ES-SCLC)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
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).
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official eligibility criteria
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. Note: at least 85% of participants included in the study must be pretreated with anti-PD-\[L\]1 therapy. Refer to protocol for country-specific requirements for participants in China. Key Exclusion Criteria: * Chemotherapy-free interval (CTFI) time from the last dose of first-line platinum-containing chemotherapy to the occurrence of progressive disease) \< 30 days (independent of the immunotherapy maintenance). * Received any prior treatment with irinotecan, topotecan, SG, SN-38, exatecan derivatives, and similar agents targeting topoisomerase I. Received lurbinectedin after progression on or after platinum-based chemotherapy. * Have carcinomatous meningitis and/or non-carcinomatous meningitis central nervous system (CNS) metastasis apart from the following noted exceptions. Participants with previously treated brain metastases may participate provided they have stable CNS disease (ie, without evidence of progression) for at least 4 weeks (independent from completion of definitive treatment) prior to randomization and all neurologic symptoms have returned to baseline, have no evidence of new or enlarging brain metastases, and are taking ≤ 10 mg/day of prednisone or its equivalent. Participants with untreated, clinically stable brain metastases will be allowed if they are asymptomatic and the investigator determines there is no immediate CNS-specific treatment required, there is no surrounding edema, and the brain metastases are of 5 mm or less in size and 3 or fewer lesions. Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study sites (23)
AK
- Alaska Oncology and Hematology · Anchorage, AK 99508More trials in Anchorage
AR
- Genesis Cancer and Blood Institute · Hot Springs, AR 71913More trials in Hot Springs
CA
- Los Angeles Cancer Network · Anaheim, CA 92801More trials in Anaheim
FL
- Boca Raton Regional · Miami, FL 33143More trials in Miami
IL
- Hope and Healing Cancer Services · Hinsdale, IL 60521More trials in Hinsdale
- Southern Illinois University School of Medicine · Springfield, IL 62702More trials in Springfield
- Springfield Clinic · Springfield, IL 62702More trials in Springfield
IN
- Parkview Research Center · Fort Wayne, IN 46845More trials in Fort Wayne
- IU Health Ball Memorial Hospital and Physicians - Cancer Center - Muncie · Muncie, IN 47303More trials in Muncie
KY
- Northwest Cancer Centers · Dyer, KY 46311More trials in Dyer
- St. Claire Regional Medical Ce · Morehead, KY 40351More trials in Morehead
- Owensboro Health Mitchell Memorial Cancer Center · Owensboro, KY 42303More trials in Owensboro
ME
- MaineHealth Cancer Care · Scarborough, ME 04074More trials in Scarborough
NM
- New Mexico Oncology Hematology Consultants, Ltd · Albuquerque, NM 87109More trials in Albuquerque
NV
- OptumCare Cancer Care · Las Vegas, NV 89102More trials in Las Vegas
OH
- University Hospitals Seidman Cancer Center · Sandusky, OH 44870More trials in Sandusky
- Taylor Cancer Research Foundation · Toledo, OH 43617More trials in Toledo
PA
- Spoknwrd Clinical Trials Inc. · Easton, PA 18045More trials in Easton
TX
- Hendrick Health System · Abilene, TX 79601More trials in Abilene
- MD Anderson Cancer Center · Houston, TX 77030More trials in Houston
- Texas Oncology - San Antonio · New Braunfels, TX 78130More trials in New Braunfels
- The University of Texas Health Science Center at Tyler · Tyler, TX 75708More trials in Tyler
WI
- Gundersen Health System · West Salem, WI 54601More trials in West Salem