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Clinical Trials List

Protocol NumberD6187C00001

NCT Number(ClinicalTrials.gov Identfier)NCT07098338

Active

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

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)

Trial Applicant

PAREXEL INTERNATIONAL CO., LTD.
Sponsor
Trial scale

Multi-Regional Multi-Center
Update

2026/04/10

Investigators and Locations

Principal Investigator Shih-Hsin Hsiao Division of Thoracic Medicine

Taipei Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 高婉真 Division of Hematology & Oncology

Chi Mei Hospital, Liouying

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 馮盈勳 Division of Hematology & Oncology

Chi Mei Medical Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 吳銘芳 Division of Thoracic Medicine

Chung Shan Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chien-Ying Liu Division of Hematology & Oncology

Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chong-Jen Yu Division of General Internal Medicine

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yung-Hung Luo Division of Thoracic Medicine

Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Te-Chun Hsia Division of General Internal Medicine

China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chun-Hui Lee

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Non-Small Cell Lung Cancer

Objectives

• Safety: To assess the safety and tolerability of the novel anticancer agents and determine the recommended dose. • Efficacy: To assess the efficacy of the novel agents in combination with other anticancer agents by evaluating the objective response rate (ORR).

Test Drug

Injectables
Injectables
Injectables

Active Ingredient

datopotamab deruxtecan
Rilvegostomig
1013005500

Dosage Form

270
270
270

Dosage

NA
NA
10 mg/mL

Endpoints

• Safety: Number of participants with adverse events (AEs) and serious adverse events (SAEs)

• Efficacy: Objective response rate (ORR)

Inclution Criteria

Inclusion Criteria for All Sub-studies:

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

Exclusion Criteria for All Sub-studies:

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

Taiwan

28 participants
Global

278 participants