Clinical Trials List
2025-03-01 - 2028-03-31
Phase I/II
Recruiting9
ICD-10C33
Malignant neoplasm of trachea
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9162.0
Malignant neoplasm of trachea
An open-label, multi-group, phase 1b/2 trial evaluating the safety, efficacy, and optimal dose of Telisotuzumab Adizutecan in combination with a PD-1 immune checkpoint inhibitor in treatment-naïve patients with untreatable genetic mutations in advanced or metastatic non-squamous non-small cell lung cancer (AndroMETa-Lung-536).
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Trial Applicant
AbbVie
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Sponsor
AbbVie Pharmaceuticals Ltd. Taiwan Branch
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Trial scale
Multi-Regional Multi-Center
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Update
2026/08/11
Investigators and Locations
Co-Principal Investigator
- 吳尚俊 無
- YEN-TING LIN 無
- Chia-Chi Lin 無
- JIN-YUAN SHIH 無
- WEI-LI MA 無
- 黃信端 無
- 黃得瑞 無
- 廖斌志 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chi-Lu Chiang 無
- Yuh-Min Chen 無
- YEN-HAN TSENG 無
- Hsu-ching Huang 無
- 廖映庭 無
- 趙恒勝 無
- Yung-Hung Luo 無
- Chia-I Shen 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 李岱晃 無
- 李玫萱 無
- 莊政皓 無
- 郭家佑 無
- Chih-Jen Yang 無
- Ying-Ming Tsai Tsai 無
- Inn-Wen Chong 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
- Evaluate the recommended Phase 3 dose (RP3D) of telisotuzumab adizutecan in combination with pembrolizumab.
- Assess efficacy based on the objective response rate (ORR) of telisotuzumab adizutecan in combination with pembrolizumab.
Inclution Criteria
- Participants must have measurable disease according to RECIST version 1.1.
- For Part 1, participants must not have received more than one systemic therapy for advanced disease, including platinum-based chemotherapy or immune checkpoint inhibitors (as monotherapy or in combination with chemotherapy), or, where applicable, appropriate targeted therapy for EGFR WT NSq NSCLC targeting gene mutations.
- For Part 2, participants must not have received systemic therapy for advanced disease and must not have known target gene mutations.
- Participants must have a documented PD-L1 status.
- Participants must have adequate organ function.
Exclusion Criteria
- Participants must not have a history of interstitial lung disease (ILD) or pneumonia requiring systemic steroid treatment, or have any evidence of active ILD or pneumonia on a screening chest CT scan.
The Estimated Number of Participants
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Taiwan
20 participants
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Global
252 participants
