Clinical Trials List
2025-09-22 - 2029-03-18
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
The master plan for an open-label, multi-drug, multicenter, phase II trial evaluates the safety, tolerability, pharmacokinetics, immunogenicity, and antitumor activity (LIBRA) of a novel combination therapy in participants with locally advanced or metastatic non-small cell lung cancer.
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Trial Applicant
PAREXEL INTERNATIONAL CO., LTD.
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Sponsor
Parexel International Co., Ltd.
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Trial scale
Multi-Regional Multi-Center
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Update
2026/07/16
Investigators and Locations
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Yu-Min Yeh 無
- Shang-Yin Wu
- Seu-Chun Yang 無
- Po-Lan Su 無
- Chin-Wei Kuo
- 蔡政軒 無
- 黃怡璇 無
- 黃怡菁
- 鍾秉軒 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
- Chia-Chi Lin 無
- James Chih-Hsin Yang 無
- JIN-YUAN SHIH 無
- 陳冠宇 無
- CHAO-CHI HO CHAO-CHI HO 無
- 黃俊凱 無
- 吳尚俊 無
- 許嘉林 無
- Jih-Hsiang Lee 無
- 蔡子修 無
- 楊景堯 無
- 錢穎群 無
- 徐偉勛 無
- 廖斌志 無
- 林昭文 無
- YEN-TING LIN 無
- 于鎧綸 無
- 黃得瑞 無
- 黃信端 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Yuh-Min Chen 無
- 蕭慈慧 無
- 張毓帆 無
- Chi-Lu Chiang 無
- Hsu-ching Huang 無
- Chia-I Shen 無
- 趙恒勝 無
- 廖映庭 無
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
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Rilvegostomig
Xinruize
Active Ingredient
Rilvegostomig
1013005500
Dosage Form
Injectables
Injectables
Dosage
NA
10 mg/mL
Endpoints
• Efficacy: Objective response rate (ORR)
Inclution Criteria
- Participant must be ≥ 18 years of age at the time of signing the ICF
- WHO/ECOG performance status of 0 or 1
- At least 1 lesion that qualifies as a RECIST 1.1 Target Lesion (TL) at baseline.
- Adequate bone marrow and organ function
- Life expectancy ≥ 12 weeks
- Provision of acceptable tumour tissue
Specific Inclusion Criteria for Sub-Study 1 and Sub-Study 2:
- Histologically or cytologically documented advanced or metastatic NSCLC
- PD-L1 TC ≥ 1% (TC≥ 50% for sub-study 1, 1-49% for sub-study 2)
- Absence of sensitizing EGFR mutations or ALK rearrangements. No known other Actionable Genomic Alterations(AGAs)
Specific Inclusion Criteria for Sub-Study 3:
- Histologically or cytologically documented advanced or metastatic non-squamous NSCLC
- Documented positive AGA and had progressed on prior targeted therapy
Exclusion Criteria
- As judged by the investigator, any severe or uncontrolled systemic diseases,in the investigator’s opinion, makes it undesirable for the participant to participate in the study or that would jeopardise compliance with the protocol
- Active or prior documented autoimmune or inflammatory disorders
- Persistent toxicities (CTCAE Grade ≥ 2) (NCI CTCAE v5.0) caused by previous anti cancer therapy, excluding alopecia.
- Spinal cord compression or leptomeningeal carcinomatosis for sub-study 1 and sub-study 2. Unstable spinal cord compression for sub-study 3
- Unstable brain metastases
- History of another primary malignancy.
- Active infection, including TB and infections with HIV, HBV (verified by known positive HBsAg result), HCV.
- Uncontrolled or significant cardiac disease
- Receipt of prior systemic chemotherapy/chemoradiation/immunotherapy for advanced NSCLC for sub-study 1 and sub-study 2.
- Prior exposure to immune-mediated therapy
- History of uncontrolled hypertension, and active bleeding diseases, and high risks of bleeding and disorders of coagulation
- Any concurrent anti-cancer treatment.
- Receipt of live, attenuated vaccine within 30 days prior to the first dose of
study intervention.
The Estimated Number of Participants
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Taiwan
28 participants
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Global
298 participants
