Recruiting
Phase 3

Sacituzumab Govitecan vs. Standard of Care

Sponsor:

Gilead Sciences

Code:

NCT06801834

Conditions

Extensive Stage Small Cell Lung Cancer (ES-SCLC)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Sacituzumab Govitecan (SG)

Topotecan

Amrubicin (Japan only)

Lurbinectedin (regions/countries where approved and available)

Study Details

Brief 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).

Conditions

Extensive Stage Small Cell Lung Cancer (ES-SCLC)

Study ID

NCT06801834

Start date

Apr 4, 2025

Status verified date

Aug, 2026

Completion date

Oct, 2029

Anticipated

Primary completion date

Oct, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

695 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Sacituzumab Govitecan (SG)

Administered intravenously

Topotecan

Administered intravenously

Amrubicin (Japan only)

Administered intravenously

Lurbinectedin (regions/countries where approved and available)

Administered intravenously

Primary outcome measure

  • Overall Survival (OS) [ Time Frame: Up to 4.5 years ]

Central Contacts and Locations

Central contacts

Gilead Clinical Study Information Cente

1-833-445-3230 (GILEAD-0)GileadClinicalTrials@gilead.com

Locations

Alaska Oncology and Hematology

Recruiting

Anchorage, Alaska, United States, 99508

Genesis Cancer and Blood Institute

Recruiting

Hot Springs, Arkansas, United States, 71913

Los Angeles Cancer Network

Recruiting

Anaheim, California, United States, 92801

Boca Raton Regional

Recruiting

Miami, Florida, United States, 33143

Hope and Healing Cancer Services

Recruiting

Hinsdale, Illinois, United States, 60521

Southern Illinois University School of Medicine

Recruiting

Springfield, Illinois, United States, 62702

Springfield Clinic

Recruiting

Springfield, Illinois, United States, 62702

Parkview Research Center

Recruiting

Fort Wayne, Indiana, United States, 46845

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

Recruiting

Muncie, Indiana, United States, 47303

Northwest Cancer Centers

Recruiting

Dyer, Kentucky, United States, 46311

St. Claire Regional Medical Ce

Recruiting

Morehead, Kentucky, United States, 40351

New Mexico Oncology Hematology Consultants, Ltd

Recruiting

Albuquerque, New Mexico, United States, 87109

University Hospitals Seidman Cancer Center

Recruiting

Sandusky, Ohio, United States, 44870

Taylor Cancer Research Foundation

Recruiting

Toledo, Ohio, United States, 43617

Spoknwrd Clinical Trials Inc.

Recruiting

Easton, Pennsylvania, United States, 18045

Hendrick Health System

Recruiting

Abilene, Texas, United States, 79601

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Texas Oncology - San Antonio

Recruiting

New Braunfels, Texas, United States, 78130

The University of Texas Health Science Center at Tyler

Recruiting

Tyler, Texas, United States, 75708

Gundersen Health System

Recruiting

West Salem, Wisconsin, United States, 54601

Royal Victoria Regional Health Centre

Recruiting

Barrie, Canada, L4M 6M2

Hamilton Health Sciences - Juravinski Cancer Centre

Recruiting

Hamilton, Canada, L8V 1C3

McGill University

Recruiting

Montreal, Canada, H4A 3J1

CISSS BSL / Hopital regional de Rimouski

Recruiting

Rimouski, Canada, G5L 5T1

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Canada, M4N 3M5

More Information

Sponsor

Gilead Sciences

Last update posted

Aug 12, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Gilead Sciences on 2026-08-12.