STATUS Recruiting

Study of Sacituzumab Govitecan Versus Standard of Care in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer (EVOKE-SCLC-04)

Gilead Clinical Study Information Center:
Monday – Friday, 5am – 6pm PT
Email: [email protected]

STATUS

Recruiting

GILEAD STUDY ID

GS-US-600-6165

Gilead Clinical Study Information Center:
Monday – Friday, 5am – 6pm PT
Email: [email protected]

LAST UPDATED

July 16, 2026

Clinicaltrials.gov ID

NCT06801834

CTSID

2024-515884-69

OVERVIEW

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) (EVOKE-SCLC-04)

PROTOCOL 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).

Participation requirements

Age

18 years +

Sex

All

Healthy Volunteers

Study details

Medical Condition

Extensive Stage Small Cell Lung Cancer (ES-SCLC)

Gender

N/A

Date

April 2025 - October 2029

Study Type

Interventional

Study Phase

Phase 3

Product

Sacituzumab Govitecan (SG), Topotecan, Amrubicin (Japan only), Lurbinectedin (regions/countries where approved and available)

Eligibility information

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.

Locations

Locations (218)

Genesis Cancer and Blood Institute

Hot Springs, Arkansas, United States, 71913

Study of Sacituzumab Govitecan Versus Standard of Care in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer (EVOKE-SCLC-04)

For more information, please contact the

For more information, please contact the

OVERVIEW

PROTOCOL SUMMARY

Participation requirements

Study details

Eligibility information

Inclusion criteria

Exclusion criteria

Locations

Locations (218)

Genesis Cancer and Blood Institute

Los Angeles Cancer Network

Boca Raton Regional

Hope and Healing Cancer Services

Southern Illinois University School of Medicine

Springfield Clinic

Parkview Research Center

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

Northwest Cancer Centers

St. Claire Regional Medical Ce

Maine Health Cancer Care

Optum Care Cancer Care

New Mexico Oncology Hematology Consultants, Ltd

University Hospitals Seidman Cancer Center

Taylor Cancer Research Foundation

Spoknwrd Clinical Trials Inc.

Hendrick Health System

MD Anderson Cancer Center

Texas Oncology - San Antonio

The University of Texas Health Science Center at Tyler

Gundersen Health System

Hospital Britanico de Buenos Aires

Universidad de Buenos Aires - Facultad de Medicina - Instituto Alexander Fleming (Buenos Aires)

Clinica Colon S.A.A (Clinica y Maternidad Colon) Investigaciones Clinicas de Mar del Plata

Centro Oncologico de Excelencia (San Juan)

Centro Médico San Roque

Sanatorio Parque SA

Cancer Care Wollongong

Metro North HHS (The Prince Charles Hospital)

Gold Coast University Hospital

Cancer Research SA

St Vincent's Hospital Melbourne

Sir Charles Gairdner Hospital

Grand Hopital de Charleroi

Jessa Ziekenhuis

Centre Hospitalier Universitaire de Liege Avenue de Lhopital 1

AZ Delta

Vitaz

Instituto do Cancer do Ceara

Hospital de Caridade de Ijui

Liga Norte-Rio-Grandense Contra o Cancer - Pesquisa Clinica

Hospital Mae de Deus

Hospital Sao Lucas da PUC Rio Grande do Sul

IMIP - Instituto de Medicina Integral Professor Fernando Figueira

Grupo Oncoclínicas

Centro de Estudos e Pesquisa de Hematologia e Oncologia

Instituto Hemomed Oncologia e Hematologia

Fundação Pio XII - Hospital de Amor

HB Onco

Hospital Amaral Carvalho

Royal Victoria Regional Health Centre

Hamilton Health Sciences - Juravinski Cancer Centre

McGill University

CISSS BSL / Hopital regional de Rimouski

Sunnybrook Health Sciences Centre

Beijing Cancer Hospital

Jilin Cancer Hospital

Sichuan Cancer Hospital

Chongqing University Cancer Hospital

Fujian Medical University Union Hospital

Sun Yat-sen University Cancer Center

The First Affiliated Hospital, Sun Yat-sen University

Zhejiang Cancer Hospital

The Second Affiliated Hospital of Zhejiang University School of Medicine

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

The First Affiliated Hospital, Zhejiang University School of Medicine

Harbin Medical University Cancer Hospital

The Second Affiliated Hospital of Nanchang University