Study Details

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 objective response rate (ORR) as assessed by blinded independent central review (BICR) according to the Response Evaluation Criteria in Solid Tumors and to compare the effect of SG to SOC on overall survival (OS).

Participation Requirements

Age

18 Years +

Sex

ALL

Healthy Volunteers

Medical Condition

Extensive Stage Small Cell Lung Cancer (ES-SCLC)

Gender

N/A

Date

April 2025 - October 2029

Study Type

INTERVENTIONAL

Study Phase

PHASE3

Product

Sacituzumab Govitecan (SG), Topotecan, Amrubicin (Japan only)

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.

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.
Untreated central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they have stable CNS disease (ie, without evidence of progression) for at least 4 weeks prior to enrollment 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.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Locations

Locations (17)

Hope and Healing Cancer Services

Hinsdale, Illinois, United States, 60521

Parkview Research Center

Fort Wayne, Indiana, United States, 46845

Taylor Cancer Research Foundation

Toledo, Ohio, United States, 43617

Spoknwrd Clinical Trials Inc.

Easton, Pennsylvania, United States, 18045

The University of Texas Health Science Center at Tyler

Tyler, Texas, United States, 75708

Cancer Care Wollongong

New South Wales, Australia, 2500

Jilin Cancer Hospital

Changchun, China, 130012

Linyi Cancer Hospital

Linyi, China, 276000

Kyushu University Hospital

Fukuoka, Japan, 812-8582

Samsung Changwon Hospital

Changwon-Si, Korea, Republic of

Chonnam National University Hwasun Hospital

Gwangju, Korea, Republic of, 61469

Samsung Medical Center

Seoul, Korea, Republic of, 06351

Gyeongsang National University Hospital

Seoul, Korea, Republic of, 52727

Ulsan University Hospital

Ulsan, Korea, Republic of, 44033

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan, 80756

National Cheng Kung University Hospital

Tainan, Taiwan, 704

Chang Gung Memorial Hospital, Linkou

Taoyuan City, Taiwan, 33305

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