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Purpose

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).

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

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 Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Treatment Group A: SG 		Participants assigned to treatment group A will receive SG 10 mg/kg intravenous (IV) infusion on Days 1 and 8 of a 21-day cycle. Participants will receive study drug until progressive disease (PD), death, unacceptable toxicity, or another treatment discontinuation criterion is met.
  • Drug: Sacituzumab Govitecan (SG)
    Administered intravenously
    Other names:
    • Trodelvy®
    • GS-0132
    • IMMU 132
Experimental
Treatment Group B: Topotecan, or Lurbinectedin, or Amrubicin 		Participants assigned to Treatment Group B will receive one of the following investigator selected treatments within a 21 day cycle: - Topotecan 1.5 mg/m² administered daily on Days 1 through 5, or - Lurbinectedin 3.2 mg/m² administered as an intravenous infusion on Day 1 (in countries/regions where lurbinectedin is approved and available). In Japan, participants assigned to Treatment Group B may alternatively receive: • Amrubicin (available only in Japan) 40 mg/m² administered daily on Days 1 through 3 of a 21 day cycle. Study treatment will continue until disease progression, death, unacceptable toxicity, or another protocol defined criterion for treatment discontinuation is met.
  • Drug: Topotecan
    Administered intravenously
  • Drug: Amrubicin (Japan only)
    Administered intravenously
  • Drug: Lurbinectedin (regions/countries where approved and available)
    Administered intravenously

Recruiting Locations

Genesis Cancer and Blood Institute
Hot Springs, Arkansas 71913

Los Angeles Cancer Network
Anaheim, California 92801

Boca Raton Regional
Miami, Florida 33143

Hope and Healing Cancer Services
Hinsdale, Illinois 60521

Southern Illinois University School of Medicine
Springfield, Illinois 62702

Springfield Clinic
Springfield, Illinois 62702

Parkview Research Center
Fort Wayne, Indiana 46845

IU Health Ball Memorial Hospital and Physicians - Cancer Center - Muncie
Muncie, Indiana 47303

Northwest Cancer Centers
Dyer, Kentucky 46311

St. Claire Regional Medical Ce
Morehead, Kentucky 40351

New Mexico Oncology Hematology Consultants, Ltd
Albuquerque, New Mexico 87109

University Hospitals Seidman Cancer Center
Sandusky, Ohio 44870

Taylor Cancer Research Foundation
Toledo, Ohio 43617

Spoknwrd Clinical Trials Inc.
Easton, Pennsylvania 18045

Hendrick Health System
Abilene, Texas 79601

MD Anderson Cancer Center
Houston, Texas 77030

Texas Oncology - San Antonio
New Braunfels, Texas 78130

The University of Texas Health Science Center at Tyler
Tyler, Texas 75708

Gundersen Health System
West Salem, Wisconsin 54601

More Details

Status
Recruiting
Sponsor
Gilead Sciences

Study Contact

Gilead Clinical Study Information Cente
1-833-445-3230 (GILEAD-0)
GileadClinicalTrials@gilead.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.