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Clinical Trials List

Protocol NumberGS-US-600-6165
Active

2025-05-01 - 2030-04-30

Phase III

Recruiting9

ICD-10C34.90

Malignant neoplasm of unspecified part of unspecified bronchus or lung

ICD-10C34.91

Malignant neoplasm of unspecified part of right bronchus or lung

ICD-10C34.92

Malignant neoplasm of unspecified part of left bronchus or lung

ICD-10C7A.090

Malignant carcinoid tumor of the bronchus and lung

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9162.9

Malignant neoplasm of bronchus and lung, unspecified

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)

  • Trial Applicant

    GILEAD SCIENCES HONG KONG LIMITED

  • Sponsor

    Gilead Sciences HK Ltd. Taiwan Branch

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator James Chih-Hsin Yang 無
National Taiwan University Cancer Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chun-Hui Lee 無
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator TSUNG -YING YANG 無
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Cheng-Ta Yang 無
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 陳鵬宇 無
Koo Foundation Sun Yat-Sen Cancer Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yuh-Min Chen 無
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 林聖皓 無
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Jen-Yu Hung
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator James Chih-Hsin Yang 無
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Extensive-stage small cell lung cancer (ES-SCLC)

Objectives

Primary Objectives: • To compare the effect of sacituzumab govitecan (SG) versus standard of care (SOC) on objective response rate (ORR) as assessed by a blinded independent central review (BICR) according to the Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1). • To compare the effect of SG versus SOC on overall survival (OS). Secondary Objectives: • To compare the effect of SG versus SOC on progression-free survival (PFS) as assessed by BICR according to RECIST v1.1. • To compare the effect of SG versus SOC on duration of response (DOR) as assessed by BICR according to RECIST v1.1. • To compare the effect of SG versus SOC on dyspnea, as evaluated by the dyspnea score item of the Non–Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ). • To compare the effect of SG versus SOC on physical functioning, as evaluated by the physical functioning score item of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, version 3.0 (EORTC QLQ-C30). • To compare the safety and tolerability of SG versus SOC.

Test Drug

sacituzumab govitecan

Active Ingredient

sacituzumab govitecan

Dosage Form

048

Dosage

180 mg

Endpoints

Objective Response Rate (ORR): Defined as the percentage of participants who achieve a complete response (CR) or partial response (PR) as assessed by the blinded independent central review (BICR) according to RECIST v1.1.

Overall Survival (OS): Defined as the time from randomization to the date of death from any cause.

Inclution Criteria

Key Inclusion Criteria:
• Histologically confirmed diagnosis of small cell lung cancer (SCLC).
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Measurable disease as assessed by the investigator according to RECIST v1.1, using computed tomography (CT) or magnetic resonance imaging (MRI).
• Radiographic documentation of disease progression following one prior line of platinum-based chemotherapy (defined as at least two treatment cycles) administered with or without anti–programmed cell death protein 1 (PD-1) or anti–programmed cell death ligand 1 (PD-L1) therapy.
(Note: At least 85% of enrolled participants must have previously received anti–PD-[L]1 therapy.)

Exclusion Criteria

Key Exclusion Criteria:
• Chemotherapy-free interval (CTFI) — defined as the time from the last dose of first-line platinum-based chemotherapy to disease progression — of less than 30 days, regardless of maintenance immunotherapy.
• Prior treatment with irinotecan, topotecan, sacituzumab govitecan (SG), SN-38, exatecan derivatives, or other topoisomerase I–targeting agents.
• Untreated central nervous system (CNS) metastases and/or carcinomatous meningitis.
Participants with previously treated brain metastases may be eligible if their CNS disease has been stable for at least 4 weeks prior to enrollment (i.e., no evidence of progression), all neurological symptoms have returned to baseline, no new or enlarging brain lesions are present, and they are receiving ≤10 mg/day of prednisone or equivalent corticosteroids.

The Estimated Number of Participants

  • Taiwan

    44 participants

  • Global

    695 participants

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