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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 trial comparing sacituzumab govitecan with standard of care (SOC) in previously treated extensive-stage small cell lung cancer (ES-SCLC) participants.

  • Trial Applicant

    GILEAD SCIENCES HONG KONG LIMITED

  • Sponsor

    Hong Kong-based Gilia Pharmaceutical Co., Ltd. Taiwan Branch

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/08/03

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 Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator TSUNG -YING YANG Division of Thoracic Medicine
Taichung Veterans General Hospital

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 Chi-Lu Chiang 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 Division of Thoracic Medicine
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Cheng-Ta Yang
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

ORR is defined as the percentage of participants who achieve a complete response (CR) or a partial response (PR) as assessed by BICR according to RECIST v1.1. OS is defined as the length of time elapsed from random assignment until the date of death from any cause.

Objectives

Primary Objectives: • To compare the effects of sacituzumab govitecan (SG) versus standard of care (SOC) on objective response rate (ORR) assessed by a blinded independent central review (BICR) according to the Solid Cancer Response Assessment Criteria, version 1.1 (RECIST v1.1). • To compare the effects of SG versus SOC on overall survival (OS). Secondary Objectives: • To compare the effects of SG versus SOC on progression-free survival (PFS) assessed by BICR according to RECIST v1.1. • To compare the effects of SG versus SOC on duration of response (DOR) assessed by BICR according to RECIST v1.1. • Compare the effects of spitting breech (SG) versus sedation breech (SOC) on shortness of breath using the Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ). • Compare the effects of SG versus SOC on physical function using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire version 3.0 (EORTC QLQ-C30) Physical Function Scoring. • Compare the safety and tolerability of SG versus SOC.

Test Drug

TRODELVY for Injection

Active Ingredient

sacituzumab govitecan

Dosage Form

Injectable frozen powder

Dosage

180 mg

Endpoints

ORR is defined as the percentage of participants who achieved a complete response (CR) or a partial response (PR) as assessed by BICR according to RECIST v1.1.

OS is defined as the length of time elapsed from random assignment until the date of death from any cause.

Inclution Criteria

Key inclusion criteria:

• Histologically confirmed SCLC.

• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.

• Measurable disease assessed by the trial administrator according to RECIST v1.1 criteria using computed tomography (CT) or magnetic resonance imaging (MRI). • Documented cases of radiographic disease progression following prior first-line platinum-based chemotherapy (defined as at least 2 treatment cycles) for ES-SCLC with or without programmed cell death protein 1 (PD-1) or programmed cell death ligand 1 (PD-L1; PD-1 and PD-L1 are hereinafter referred to as PD-[L]1)-directed therapy (Note: at least 85% of participants enrolled in the trial must have previously received anti-PD-[L]1 therapy).

Exclusion Criteria

Key exclusion criteria:

• Chemotherapy-free interval (CTFI): <30 days from the last dose of first-line platinum-based chemotherapy to disease progression (regardless of maintenance immunotherapy).

• Prior treatment with irinotecan, topothecan, SG, SN-38, exatecan derivatives, or similar drugs targeting type I topoisomerases.

• Untreated central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases are eligible if their CNS disease has remained stable (i.e., no evidence of progression) for at least 4 weeks prior to recruitment, all neurological symptoms have returned to baseline, there is no evidence of new or increasing brain metastases, and they are currently taking ≤10 mg/day of prednisone or an equivalent drug.

The Estimated Number of Participants

  • Taiwan

    44 participants

  • Global

    695 participants

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