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 (70)

Hope and Healing Cancer Services

Hinsdale, Illinois, United States, 60521

Southern Illinois University School of Medicine

Springfield, Illinois, United States, 62702

Springfield Clinic

Springfield, Illinois, United States, 62702

Parkview Research Center

Fort Wayne, Indiana, United States, 46845

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

Muncie, Indiana, United States, 47303

Northwest Cancer Centers

Dyer, Kentucky, United States, 46311

Taylor Cancer Research Foundation

Toledo, Ohio, United States, 43617

Spoknwrd Clinical Trials Inc.

Easton, Pennsylvania, United States, 18045

Hendrick Health System

Abilene, Texas, United States, 79601

MD Anderson Cancer Center

Houston, Texas, United States, 77030

The University of Texas Health Science Center at Tyler

Tyler, Texas, United States, 75708

Cancer Care Wollongong

New South Wales, New South Wales, Australia, 2500

Metro North HHS (The Prince Charles Hospital)

Queensland, Queensland, Australia, 4006

Cancer Research SA

Adelaide, South Australia, Australia, 5000

St Vincent's Hospital Melbourne

Fitzroy, Victoria, Australia, 3065

Jilin Cancer Hospital

Changchun, China, 130012

Sichuan Cancer Hospital

Chengdu, China, 610041

Chongqing University Cancer Hospital

Chongqing, China, 404100

Sun Yat-sen University Cancer Center

Guangzhou, China, 130012

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, China, 310016

Harbin Medical University Cancer Hospital

Harbin, China, 150081

The Second Affiliated Hospital of Nanchang University

Jiangxi, China, 330008

The Second Affiliated Hospital of Kunming Medical University

Kunming, China, 650000

Linyi Cancer Hospital

Linyi, China, 276000

Fudan University Shanghai Cancer Center

Shanghai, China

Tianjin Medical University Cancer Institute & Hospital

Tianjin, China, 300181

Weifang No.2 People's Hospital

Weifang, China, 261041

Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology

Wuhan, China, 430030

Institut Curie

Paris, France, 75248

Katholisches Marienkrankenhaus gGmbH

Hamburg, Germany, 22087

Soroka Medical Center

Beersheba, Israel, 84001

Hadassah Medical Center

Jerusalem, Israel, 9112001

Istituto Nazionale Tumori IRCCS Fondazione G. Pascale

Naples, Italy, 80131

Casa di cura Pederzoli

Peschiera del Garda, Italy, 37019

Istituti di Ricovero e Cura A Carattere Scientifico - Istituti Fisioterapici Ospitalieri

Roma, Italy, 144

Kyushu University Hospital

Fukuoka, Japan, 812-8582

Kurume University Hospital

Fukuoka, Japan, 830-0011

Sendai Kousei Hospital

Miyagi, Japan, 981-0914

Okayama University Hospital

Okayama, Japan, 700-8558

Kansai Medical University Hospital

Osaka, Japan, 573-1191

National Hospital Organization Kinki Chuo Chest Medical Center

Osaka, Japan, 591-8555

Saitama Prefectural Cancer Center

Saitama, Japan, 362-0806

The Cancer Institute Hospital of JFCR

Tokyo, Japan, 135-8550

Sunway Medical Centre

Kuala Selangor, Malaysia, 47500

Sint Antonius Ziekenhuis

Utrecht, Netherlands, 3543 AZ

Podkarpackie Centrum Onkologii Rzeszow

Rzeszów, Poland, 35-055

Mazowiecki Szpital Wojewódzki im. św. Jana Pawła II w Siedlcach

Siedlce, Poland, 08-110

Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Słupsku

Stupsk, Poland, 076-200

Samsung Changwon Hospital

Changwon-Si, South Korea

Chonnam National University Hwasun Hospital

Gwangju, South Korea, 61469

Seoul National University Bundang Hospital

Seongnam, South Korea, 13620

Kangbuk Samsung Hospital

Seoul, South Korea, 03181

Asan Medical Center

Seoul, South Korea, 05505

Samsung Medical Center

Seoul, South Korea, 06351

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, South Korea, 06591

Yonsei University Severance Hospital

Seoul, South Korea, 120-752

Gyeongsang National University Hospital

Seoul, South Korea, 52727

The Catholic University of Korea, St. Vincent's Hospital

Suwon, South Korea, 16247

Ulsan University Hospital

Ulsan, South Korea, 44033

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain, 08041

Institut Catala d'Oncologia Girona

Girona, Spain, 17007

Hospital Universitario Virgen de Valme

Seville, Spain, 41014

Hospital Clínico Universitario de Valencia

Valencia, Spain, 46010

Changhua Christian Hospital

Changhua, Taiwan, 500-06

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan, 80756

National Cheng Kung University Hospital

Tainan City, Taiwan, 704

Taipei Veterans General Hospital

Taipei, Taiwan, 10002

National Taiwan University Cancer Center

Taipei, Taiwan, 100

Koo Foundation Sun Yat-Sen Cancer Center

Taipei, Taiwan, 112

Chang Gung Memorial Hospital, Linkou

Taoyuan, Taiwan, 33305

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