Clinical Trials List
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)
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Trial Applicant
GILEAD SCIENCES HONG KONG LIMITED
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2026/06/12
Investigators and Locations
Co-Principal Investigator
- 吳尚俊 無
- JIN-YUAN SHIH 無
- Chia-Chi Lin 無
- 黃得瑞 無
- 林宗哲 無
- WEI-LI MA 無
- 廖斌志 無
- YEN-TING LIN 無
- 黃信端 無
- 黃信瑞 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chih-Liang Wang 無
- 林定佑 無
- Chih-Hsi Kuo 無
- Chien-Ying Liu 無
- 枋岳甫 無
- Ping-Chih Hsu 無
- 吳教恩 無
- 邱立忠 無
- Chih-Hung Chen 無
- Fu-Tsai Chung 無
- Shih-Hong Li 無
- 柯皓文 無
- 黃宗禎 無
- 吳浩銘 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- YEN-HAN TSENG 無
- Yung-Hung Luo 無
- 趙恒勝 無
- Hsu-ching Huang 無
- Chi-Lu Chiang 無
- 廖映庭 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 莊政皓 Division of Thoracic Medicine
- Inn-Wen Chong Division of Thoracic Medicine
- Ying-Ming Tsai Tsai Division of Thoracic Medicine
- 郭家佑 Division of Thoracic Medicine
- 李玫萱 Division of Thoracic Medicine
- Chih-Jen Yang Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chien-Chung Lin Division of Hematology & Oncology
- 蔡政軒 Division of Hematology & Oncology
- Shang-Yin Wu Division of Hematology & Oncology
- Yu-Min Yeh Division of Hematology & Oncology
- 黃怡璇
- 黃怡菁 Division of Hematology & Oncology
- 鍾秉軒 Division of Hematology & Oncology
- Seu-Chun Yang Division of Hematology & Oncology
- Wu-Chou Su Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
OS is defined as the length of time elapsed from random assignment until the date of death from any cause.
Inclution 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.
Individuals treated with a platinum-based therapy for prior limited stage small cell lung cancer will be counted as 1 prior line of platinum-containing chemotherapy if the disease has progressed within 30 to 180 days from last dose of platinum treatment.
If the investigator believes a participant may benefit from platinum rechallenge it can be considered per investigator discretion and local SOC; however, participants with platinum rechallenge may not participate in the study.
If the investigator believes a participant may benefit from tarlatamab treatment, it can be considered per investigator discretion and local SOC and such participants may participate in the study following tarlatamab treatment.
Note: at least 85% of participants included in the study must be pretreated with anti-PD-[L]1 therapy.
Refer to protocol for country-specific requirements for participants in China.
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. Received lurbinectedin after progression on or after platinum-based chemotherapy.
Have carcinomatous meningitis and/or non-carcinomatous meningitis central nervous system (CNS) metastasis apart from the following noted exceptions. Participants with previously treated brain metastases may participate provided they have stable CNS disease (ie, without evidence of progression) for at least 4 weeks (independent from completion of definitive treatment) prior to randomization 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. Participants with untreated, clinically stable brain metastases will be allowed if they are asymptomatic and the investigator determines there is no immediate CNS-specific treatment required, there is no surrounding edema, and the brain metastases are of 5 mm or less in size and 3 or fewer lesions.
The Estimated Number of Participants
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Taiwan
44 participants
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Global
695 participants
