Clinical Trials List
2026-02-26 - 2028-04-30
Phase II
Not yet recruiting1
Recruiting7
A Phase 2, Open-label, Multicohort Study of Rinatabart Sesutecan (Rina-S) in Participants With Non-Small Cell Lung Cancer
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Trial Applicant
Pharmaceutical Research Associates Taiwan Inc.
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2026/09/10
Investigators and Locations
Co-Principal Investigator
- Chih-Jen Yang 無
- Inn-Wen Chong 無
- 李玫萱 無
- Ying-Ming Tsai Tsai 無
- 郭家佑 無
- KUAN-LI WU 無
- 莊政皓 無
- 李岱晃 無
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chia-Chi Lin 無
- Chong-Jen Yu 無
- JIN-YUAN SHIH 無
- 陳冠宇 無
- 廖唯昱 無
- CHAO-CHI HO CHAO-CHI HO 無
- 吳尚俊 無
- 許嘉林 無
- Jih-Hsiang Lee 無
- 蔡子修 無
- 楊景堯 無
- 徐偉勛 無
- 廖斌志 無
- WEI-LI MA 無
- YEN-TING LIN 無
- 黃得瑞 無
- 黃信端 無
The Actual Total Number of Participants Enrolled
0 Recruiting
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-Yen Tu 無
- 陳鴻仁 無
- Yu-Chao Lin 無
- Chia-Hsiang Li 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Inclution Criteria
Participant has histologically or cytologically confirmed metastatic or locally advanced NSCLC of adenocarcinoma histology, not amenable to curative surgery or radiotherapy.
Participant must have radiological disease progression while on or after receiving the most recent regimen.
Participants either may have actionable genetic alterations (AGAs) or no AGAs.
Participant has measurable disease according to RECIST v1.1.
Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1 within 7 days of Cycle 1 Day 1.
Exclusion Criteria
Participant has NSCLC with histology other than adenocarcinoma
Participant has a past or current malignancy other than the inclusion diagnosis before the planned first dose of trial treatment, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death (eg, 5-year OS ≥ 90%), including, but not limited to, adequately treated cervical carcinoma of stage 1B or less, in situ basal cell or squamous cell skin carcinoma, in situ bladder cancer, ductal carcinoma in situ, or any past malignancy considered cured for ≥ 3 years.
Participants with newly identified or known unstable (eg, progressing brain metastases) or symptomatic central nervous system (CNS) metastases or history of carcinomatous meningitis (also known as leptomeningeal disease). Participants with history of spinal cord compression (from disease). Participants with previous CNS-directed therapy (eg, radiotherapy and/or surgery) for brain metastases may participate provided lesion(s) are radiologically stable (ie, without evidence of progression) for at least 28 days by repeat imaging.
The Estimated Number of Participants
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Taiwan
6 participants
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Global
240 participants