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RecruitingInterventionalPhase 3

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)

NCT ID: NCT06801834Sponsor: Gilead SciencesLast updated: 2026-05-20

Summary

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).

Arms & interventions

  • DrugSacituzumab Govitecan (SG)

    Administered intravenously

  • DrugTopotecan

    Administered intravenously

  • DrugAmrubicin (Japan only)

    Administered intravenously

  • DrugLurbinectedin (regions/countries where approved and available)

    Administered intravenously

Outcome measures

Primary

  • Overall Survival (OS)

    OS is defined as length of time from randomization until the date of death from any cause.

    Time frame: Up to 4.5 years

Secondary

  • Progression-free Survival (PFS)

    Time frame: Up to 4.5 years

  • Objective Response Rate (ORR)

    Time frame: Up to 4.5 years

  • Duration of Response (DOR)

    Time frame: Up to 4.5 years

  • Time to First Deterioration in Shortness of Breath Domain

    Time frame: Up to 4.5 years

  • Time to First Deterioration in Physical Functioning Domain

    Time frame: Up to 4.5 years

  • Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)

    Time frame: First dose date up to 4.5 years

  • Percentage of Participants Experiencing Clinical Laboratory abnormalities

    Time frame: First dose date up to 4.5 years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 locations (19)

Genesis Cancer and Blood Institute

Hot Springs, Arkansas, 71913

Not Yet Recruiting

Los Angeles Cancer Network

Anaheim, California, 92801

Recruiting

Boca Raton Regional

Miami, Florida, 33143

Recruiting

Hope and Healing Cancer Services

Hinsdale, Illinois, 60521

Recruiting

Southern Illinois University School of Medicine

Springfield, Illinois, 62702

Recruiting

Springfield Clinic

Springfield, Illinois, 62702

Recruiting

Parkview Research Center

Fort Wayne, Indiana, 46845

Recruiting

IU Health Ball Memorial Hospital and Physicians - Cancer Center - Muncie

Muncie, Indiana, 47303

Recruiting

Northwest Cancer Centers

Dyer, Kentucky, 46311

Recruiting

St. Claire Regional Medical Ce

Morehead, Kentucky, 40351

Recruiting

New Mexico Oncology Hematology Consultants, Ltd

Albuquerque, New Mexico, 87109

Recruiting

University Hospitals Seidman Cancer Center

Sandusky, Ohio, 44870

Recruiting

Taylor Cancer Research Foundation

Toledo, Ohio, 43617

Recruiting

Spoknwrd Clinical Trials Inc.

Easton, Pennsylvania, 18045

Recruiting

Hendrick Health System

Abilene, Texas, 79601

Recruiting

MD Anderson Cancer Center

Houston, Texas, 77030

Recruiting

Texas Oncology - San Antonio

New Braunfels, Texas, 78130

Recruiting

The University of Texas Health Science Center at Tyler

Tyler, Texas, 75708

Recruiting

Gundersen Health System

West Salem, Wisconsin, 54601

Recruiting