問卷
Log In
繁中 EN
TPIDB
TPIDB Outstanding PI
TPIDB > Search Result > Clinical Trials List

Clinical Trials List

Protocol NumberGS-US-600-6165
NCT Number(ClinicalTrials.gov Identfier)NCT06801834
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

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/04/10

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 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 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 James Chih-Hsin Yang 無
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chun-Hui Lee
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 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

Injectable frozen powder

Active Ingredient

sacituzumab govitecan

Dosage Form

048

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 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

Key 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.

The Estimated Number of Participants

  • Taiwan

    44 participants

  • Global

    695 participants

聯絡我們

台灣臨床試驗主持人資料庫 TPIDB

All Contents Copyright 2020 台灣臨床試驗主持人資料庫TPIDB