A Study of Novel Combinations in Non-Small Cell Lung Cancer (NSCLC)
LIBRA
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)
1 other identifier
interventional
278
9 countries
64
Brief Summary
This is a Phase II, multi-center, open-label platform study evaluating novel combination treatment options in participants with locally advanced or metastatic NSCLC. The study will consist of several sub-studies, each evaluating the safety, tolerability, and preliminary antitumour activity of various treatment combinations. This study will be conducted in approximately 80 centers globally across 10 countries.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 nonsmall-cell-lung-cancer
Started Aug 2025
Typical duration for phase_2 nonsmall-cell-lung-cancer
64 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 4, 2025
CompletedFirst Posted
Study publicly available on registry
August 1, 2025
CompletedStudy Start
First participant enrolled
August 7, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 6, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 6, 2029
April 29, 2026
April 1, 2026
3.7 years
July 4, 2025
April 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of participants with adverse events (AE) and serious adverse events (SAE)
To assess the safety and tolerability
Through study completion, an average of 3 years
Objective response rate (ORR)
ORR is defined as the proportion of participants who have a confirmed CR (complete response) or confirmed PR (partial response) per RECIST 1.1
Through study completion, an average of 3 years
Secondary Outcomes (9)
Best Overall Response(BOR)
Through study completion, an average of 3 years
Change in Target Lesion Tumor Size
Through study completion, an average of 3 years
Progression free survival (PFS)
Through study completion, an average of 3 years
Disease Control Rate(DCR) at 12 Weeks
From Day 1 pre-dose to 12 weeks
Duration Of Response (DoR)
Through study completion, an average of 3 years
- +4 more secondary outcomes
Study Arms (3)
Sub-study 1, investigate rilvegostomig± ramucirumab in 1L non-AGA NSCLC with PD-L1 ≥50%
EXPERIMENTALParticipants will receive rilvegostomig ± ramucirumab until RECIST 1.1-defined radiological progression, unacceptable toxicity, withdrawal of consent, or other discontinuation criterion
Sub-study 2, investigate rilvegostomig + ramucirumab in 1L non-AGA NSCLC with PD-L1 1-49%
EXPERIMENTALParticipants will receive rilvegostomig + ramucirumab until RECIST 1.1-defined radiological progression, unacceptable toxicity, withdrawal of consent, or other discontinuation criterion
Sub-study 3, investigate Dato-DXd + ramucirumab ± rilvegostomig in 2/3L AGA+ NSCLC
EXPERIMENTALParticipants will receive Dato-DXd + ramucirumab ± rilvegostomig until RECIST 1.1-defined radiological progression, unacceptable toxicity, withdrawal of consent, or other discontinuation criterion
Interventions
Ramucirumab will be administered as IV infusion.
Dato-DXd will be administered as IV infusion.
Rilvegostomig will be administered as IV infusion.
Eligibility Criteria
You may qualify if:
- 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
- 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)
- Histologically or cytologically documented advanced or metastatic non-squamous NSCLC
- Documented positive AGA and had progressed on prior targeted therapy
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Daiichi Sankyocollaborator
Study Sites (64)
Research Site
Santa Monica, California, 90404, United States
Research Site
Santa Rosa, California, 95403, United States
Research Site
Atlanta, Georgia, 30318, United States
Research Site
Baltimore, Maryland, 21231, United States
Research Site
Houston, Texas, 77090, United States
Research Site
Fairfax, Virginia, 22031, United States
Research Site
Heidelberg, 3084, Australia
Research Site
Nedlands, 6009, Australia
Research Site
Woodville, 5011, Australia
Research Site
Toronto, Ontario, M5G 2M9, Canada
Research Site
Changsha, 410013, China
Research Site
Chengdu, 610041, China
Research Site
Deyang, 618000, China
Research Site
Dongguan, 523059, China
Research Site
Fuzhou, 350014, China
Research Site
Guangzhou, 510080, China
Research Site
Guangzhou, 510100, China
Research Site
Hangzhou, 310014, China
Research Site
Hefei, 230022, China
Research Site
Linyi, 276001, China
Research Site
Mianyang, 621000, China
Research Site
Nanchang, 330000, China
Research Site
Nanchang, 330006, China
Research Site
Shantou, China
Research Site
Shenyang, 110042, China
Research Site
Wuhan, 430022, China
Research Site
Zhengzhou, 450000, China
Research Site
Zhengzhou, 450008, China
Research Site
Zhuhai, 519000, China
Research Site
Bunkyō City, 113-8677, Japan
Research Site
Fukuyama-shi, 722-0001, Japan
Research Site
Kobe, 650-0047, Japan
Research Site
Kurume-shi, 830-0011, Japan
Research Site
Kyoto, 602-8566, Japan
Research Site
Kyoto, 606-8507, Japan
Research Site
Osaka, 541-8567, Japan
Research Site
Sakaishi, 591-8555, Japan
Research Site
Shinjuku-ku, 162-8655, Japan
Research Site
Wakayama, 641-8510, Japan
Research Site
Yokohama, 236-0051, Japan
Research Site
Singapore, 119082, Singapore
Research Site
Singapore, 168583, Singapore
Research Site
Cheongju-si, 28644, South Korea
Research Site
Namdong-gu, 21565, South Korea
Research Site
Seongnam-si, 13496, South Korea
Research Site
Seoul, 03080, South Korea
Research Site
Seoul, 06351, South Korea
Research Site
Seoul, 3722, South Korea
Research Site
Seoul, 5505, South Korea
Research Site
Suwon, 16247, South Korea
Research Site
Suwon, 16499, South Korea
Research Site
Liuying, 736, Taiwan
Research Site
Taichung, 402, Taiwan
Research Site
Taichung, 40447, Taiwan
Research Site
Tainan, 70403, Taiwan
Research Site
Tainan, 710, Taiwan
Research Site
Taipei, 100, Taiwan
Research Site
Taipei, 110, Taiwan
Research Site
Taipei, 11217, Taiwan
Research Site
Taoyuan District, 00333, Taiwan
Research Site
Bangkok, 10330, Thailand
Research Site
Bangkok, 10400, Thailand
Research Site
Bangkok, 10700, Thailand
Research Site
Banphaeo, 74120, Thailand
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 4, 2025
First Posted
August 1, 2025
Study Start
August 7, 2025
Primary Completion (Estimated)
April 6, 2029
Study Completion (Estimated)
April 6, 2029
Last Updated
April 29, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.