Study of Sacituzumab Govitecan Versus Standard of Care in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer

Last updated: August 8, 2025
Sponsor: Gilead Sciences
Overall Status: Active - Recruiting

Phase

3

Condition

Small Cell Lung Cancer

Treatment

Topotecan

Amrubicin (Japan only)

Sacituzumab Govitecan (SG)

Clinical Study ID

NCT06801834
GS-US-600-6165
2024-515884-69
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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 ofplatinum-containing chemotherapy (defined as at least 2 cycles of treatment) with orwithout therapy directed against programmed cell death protein 1 (PD-1) orprogrammed cell death ligand 1 (PD-L1; PD-1 and PD-L1 are hereafter referred to asPD-(L)1) for ES-SCLC.

Exclusion

Key Exclusion Criteria:

  • Chemotherapy-free interval (CTFI) time from the last dose of first-lineplatinum-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, exatecanderivatives, 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 theyhave stable CNS disease (ie, without evidence of progression) for at least 4 weeksprior to enrollment and all neurologic symptoms have returned to baseline, have noevidence of new or enlarging brain metastases, and are taking ≤ 10 mg/day ofprednisone or its equivalent.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Total Participants: 695
Treatment Group(s): 3
Primary Treatment: Topotecan
Phase: 3
Study Start date:
April 04, 2025
Estimated Completion Date:
October 31, 2029

Connect with a study center

  • Cancer Research SA

    Adelaide, South Australia 5000
    Australia

    Active - Recruiting

  • St Vincent's Hospital Melbourne

    Fitzroy, Victoria 3065
    Australia

    Active - Recruiting

  • Cancer Care Wollongong

    New South Wales, 2500
    Australia

    Active - Recruiting

  • Metro North HHS (The Prince Charles Hospital)

    Queensland, 4006
    Australia

    Active - Recruiting

  • Jilin Cancer Hospital

    Changchun, 130012
    China

    Active - Recruiting

  • Sichuan Cancer Hospital

    Chengdu, 610041
    China

    Active - Recruiting

  • Chongqing University Cancer Hospital

    Chongqing, 404100
    China

    Active - Recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, 130012
    China

    Active - Recruiting

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

    Hangzhou, 310016
    China

    Active - Recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, 150081
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Nanchang University

    Jiangxi, 330008
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Kunming Medical University

    Kunming, 650000
    China

    Active - Recruiting

  • Linyi Cancer Hospital

    Linyi, 276000
    China

    Active - Recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai,
    China

    Active - Recruiting

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, 300181
    China

    Active - Recruiting

  • Weifang No.2 People's Hospital

    Weifang, 261041
    China

    Active - Recruiting

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

    Wuhan, 430030
    China

    Active - Recruiting

  • Institut Curie

    Paris, 75248
    France

    Active - Recruiting

  • Katholisches Marienkrankenhaus gGmbH

    Hamburg, 22087
    Germany

    Active - Recruiting

  • Soroka Medical Center

    Beer-Sheva, 84001
    Israel

    Active - Recruiting

  • Hadassah Medical Center

    Jerusalem, 9112001
    Israel

    Active - Recruiting

  • Istituto Nazionale Tumori IRCCS Fondazione G. Pascale

    Naples, 80131
    Italy

    Active - Recruiting

  • Casa di cura Pederzoli

    Peschiera del Garda, 37019
    Italy

    Active - Recruiting

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

    Roma, 144
    Italy

    Active - Recruiting

  • Kurume University Hospital

    Fukuoka, 830-0011
    Japan

    Active - Recruiting

  • Kyushu University Hospital

    Fukuoka, 812-8582
    Japan

    Active - Recruiting

  • Sendai Kousei Hospital

    Miyagi, 981-0914
    Japan

    Active - Recruiting

  • Okayama University Hospital

    Okayama, 700-8558
    Japan

    Active - Recruiting

  • Kansai Medical University Hospital

    Osaka, 573-1191
    Japan

    Active - Recruiting

  • National Hospital Organization Kinki Chuo Chest Medical Center

    Osaka, 591-8555
    Japan

    Active - Recruiting

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

    Saitama, 362-0806
    Japan

    Active - Recruiting

  • Saitama Prefectural Cancer Center

    Saitama, 362-0806
    Japan

    Active - Recruiting

  • The Cancer Institute Hospital of JFCR

    Tokyo, 135-8550
    Japan

    Active - Recruiting

  • Samsung Changwon Hospital

    Changwon-Si,
    Korea, Republic of

    Active - Recruiting

  • Chonnam National University Hwasun Hospital

    Gwangju, 61469
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Bundang Hospital

    Seongnam, 13620
    Korea, Republic of

    Active - Recruiting

  • Asan Medical Center

    Seoul, 05505
    Korea, Republic of

    Active - Recruiting

  • Gyeongsang National University Hospital

    Seoul, 52727
    Korea, Republic of

    Active - Recruiting

  • Kangbuk Samsung Hospital

    Seoul, 03181
    Korea, Republic of

    Active - Recruiting

  • Samsung Medical Center

    Seoul, 06351
    Korea, Republic of

    Active - Recruiting

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

    Seoul, 06591
    Korea, Republic of

    Active - Recruiting

  • Yonsei University Severance Hospital

    Seoul, 120-752
    Korea, Republic of

    Active - Recruiting

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

    Suwon, 16247
    Korea, Republic of

    Active - Recruiting

  • Ulsan University Hospital

    Ulsan, 44033
    Korea, Republic of

    Active - Recruiting

  • Sunway Medical Centre

    Selangor, 47500
    Malaysia

    Active - Recruiting

  • Sint Antonius Ziekenhuis

    Utrecht, 3543 AZ
    Netherlands

    Active - Recruiting

  • Podkarpackie Centrum Onkologii Rzeszow

    Rzeszow, 35-055
    Poland

    Active - Recruiting

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

    Siedlce, 08-110
    Poland

    Active - Recruiting

  • Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Słupsku

    Stupsk, 076-200
    Poland

    Active - Recruiting

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041
    Spain

    Active - Recruiting

  • Institut Catala d'Oncologia Girona

    Girona, 17007
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen de Valme

    Sevilla, 41014
    Spain

    Active - Recruiting

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010
    Spain

    Active - Recruiting

  • Changhua Christian Hospital

    Changhua City, 500-06
    Taiwan

    Active - Recruiting

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 80756
    Taiwan

    Active - Recruiting

  • National Cheng Kung University Hospital

    Tainan, 704
    Taiwan

    Active - Recruiting

  • Koo Foundation Sun Yat-Sen Cancer Center

    Taipei, 112
    Taiwan

    Active - Recruiting

  • National Taiwan University Cancer Center

    Taipei, 100
    Taiwan

    Active - Recruiting

  • Taipei Veterans General Hospital

    Taipei, 10002
    Taiwan

    Active - Recruiting

  • Chang Gung Memorial Hospital, Linkou

    Taoyuan City, 33305
    Taiwan

    Active - Recruiting

  • Hope and Healing Cancer Services

    Hinsdale, Illinois 60521
    United States

    Active - Recruiting

  • Southern Illinois University School of Medicine

    Springfield, Illinois 62702
    United States

    Active - Recruiting

  • Springfield Clinic

    Springfield, Illinois 62702
    United States

    Active - Recruiting

  • Parkview Research Center

    Fort Wayne, Indiana 46845
    United States

    Active - Recruiting

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

    Muncie, Indiana 47303
    United States

    Active - Recruiting

  • Northwest Cancer Centers

    Dyer, Kentucky 46311
    United States

    Active - Recruiting

  • Taylor Cancer Research Foundation

    Toledo, Ohio 43617
    United States

    Active - Recruiting

  • Spoknwrd Clinical Trials Inc.

    Easton, Pennsylvania 18045
    United States

    Active - Recruiting

  • Hendrick Health System

    Abilene, Texas 79601
    United States

    Active - Recruiting

  • MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • The University of Texas Health Science Center at Tyler

    Tyler, Texas 75708
    United States

    Active - Recruiting

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