Phase II, multi-center, open-label platform study evaluating novel combination treatment options in participants with locally advanced or metastatic NSCLC.

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) - LIBRA

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2051250123

Enrollment

278

Registered

2025-10-01

Start date

2025-10-10

Completion date

Unknown

Last updated

2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

locally advanced or metastatic NSCLC

Interventions

Sub-study 1, investigate rilvegostomig+- ramucirumab in 1L non-AGA NSCLC with PD-L1 50% or more Sub-study 2, investigate rilvegostomig + ramucirumab in 1L non-AGA NSCLC with PD-L1 1-49% Sub-study 3,

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion Criteria for All Sub-studies: - Participant must be 18 or more 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 - 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% or more (TC 50% or more 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: 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 or more) (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.

Design outcomes

Primary

Measure	Time frame
- Number of participants with adverse events (AE) and serious adverse events (SAE) -Objective response rate (ORR)	—

Countries

Australia, Canada, China, Japan, Malaysia, Singapore, South Korea, Taiwan, Thailand, United States

Contacts

Public ContactKazushige Hibi

Astrazeneka K.K

RD-clinical-information-Japan@astrazeneca.com+81-6-4802-3600

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Feb 4, 2026