Clinical Trials List
2025-09-22 - 2029-03-18
Phase II
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 Master Protocol of an Open-Label, Multi-Drug, Multi-Centre, Phase II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumour Activity of Novel Combinations in Participants with Locally Advanced or Metastatic Non-Small Cell Lung Cancer (LIBRA)
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Trial Applicant
PAREXEL INTERNATIONAL CO., LTD.
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Sponsor
AstraZeneca AB
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Trial scale
Multi-Regional Multi-Center
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Update
2026/03/01
Investigators and Locations
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Shang-Yin Wu 無
- 黃怡菁 無
- 蔡政軒 無
- 黃怡璇 無
- 鍾秉軒 無
- Chin-Wei Kuo 無
- Yu-Min Yeh 無
- Chien-Chung Lin 無
- Seu-Chun Yang 無
- Po-Lan Su 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
- Cheng-Ta Yang 無
- 吳教恩 無
- Ping-Chih Hsu 無
- 黃振洋 無
- 林定佑 無
- Chih-Liang Wang 無
- Shih-Hong Li 無
- Wen-Cheng Chang 無
- Chih-Hsi Kuo 無
- 吳振德 無
- 柯皓文 無
- 黃宗楨 無
- 邱立忠 無
- Jia-Shiuan Ju 無
- 枋岳甫 無
- Chih-Hung Chen 無
- Ching-His Siao 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- James Chih-Hsin Yang 無
- 吳尚俊 無
- 徐偉勛 無
- 廖斌志 無
- Jih-Hsiang Lee 無
- 楊景堯 無
- YEN-TING LIN 無
- 許嘉林 無
- CHAO-CHI HO CHAO-CHI HO 無
- 黃俊凱 無
- 錢穎群 無
- Chia-Chi Lin 無
- 廖唯昱 無
- JIN-YUAN SHIH 無
- 蔡子修 無
- 林昭文 無
- 陳冠宇 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Yuh-Min Chen 無
- 蕭慈慧 無
- Chi-Lu Chiang 無
- Hsu-ching Huang 無
- 張毓帆 無
- 趙恒勝 無
- 張晉瑜 無
- 廖映庭 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chih-Yen Tu 無
- Yu-Chao Lin 無
- Chia-Hsiang Li 無
- 陳鴻仁 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Rilvegostomig
Ramucirumab
Dosage Form
270
270
Dosage
NA
10 mg/mL
Endpoints
(evaluated only in the Safety Run-in a), AEs/SAEs,
AESIs, AEs leading to discontinuation, physical
examinations, vital signs, ECGs, and laboratory findings.
The estimates of interest are:
• Incidence of AEs/SAEs, AESIs, and AEs leading to
discontinuation
• Incidence of DLTs (evaluated only in the Safety
Run-in)
• Mean changes from baseline in physical
examinations, vital signs, ECGs, and laboratory
parameters
The analysis will include participants in the Safety
Analysis Set. Participants will be analysed according to
the treatment they actually receive.
The analysis of DLT will include participants in the
DLT-evaluable Set.
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
278 participants
