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)
Status: Recruiting
Location: See all (83) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
California
Research Site
NOT_YET_RECRUITING
Santa Monica
Research Site
NOT_YET_RECRUITING
Santa Rosa
Georgia
Research Site
RECRUITING
Atlanta
Maryland
Research Site
NOT_YET_RECRUITING
Baltimore
Texas
Research Site
NOT_YET_RECRUITING
Houston
Virginia
Research Site
RECRUITING
Fairfax
Other Locations
Australia
Research Site
NOT_YET_RECRUITING
Heidelberg
Research Site
NOT_YET_RECRUITING
Nedlands
Research Site
NOT_YET_RECRUITING
Woodville
Canada
Research Site
NOT_YET_RECRUITING
Toronto
China
Research Site
RECRUITING
Changsha
Research Site
RECRUITING
Chengdu
Research Site
RECRUITING
Deyang
Research Site
RECRUITING
Dongguan
Research Site
WITHDRAWN
Fuzhou
Research Site
RECRUITING
Guangzhou
Research Site
RECRUITING
Guangzhou
Research Site
RECRUITING
Hangzhou
Research Site
RECRUITING
Hefei
Research Site
RECRUITING
Linyi
Research Site
RECRUITING
Mianyang
Research Site
RECRUITING
Nanchang
Research Site
RECRUITING
Nanchang
Research Site
RECRUITING
Shantou
Research Site
RECRUITING
Shenyang
Research Site
RECRUITING
Wuhan
Research Site
RECRUITING
Zhengzhou
Research Site
RECRUITING
Zhengzhou
Research Site
RECRUITING
Zhuhai
France
Research Site
NOT_YET_RECRUITING
Avignon
Research Site
NOT_YET_RECRUITING
Paris
Research Site
NOT_YET_RECRUITING
Rennes
Research Site
NOT_YET_RECRUITING
Saint-herblain
Research Site
NOT_YET_RECRUITING
Suresnes
Italy
Research Site
NOT_YET_RECRUITING
Aviano
Research Site
NOT_YET_RECRUITING
Catania
Research Site
NOT_YET_RECRUITING
Meldola
Research Site
NOT_YET_RECRUITING
Milan
Research Site
NOT_YET_RECRUITING
Milan
Research Site
NOT_YET_RECRUITING
Orbassano
Research Site
NOT_YET_RECRUITING
Roma
Research Site
NOT_YET_RECRUITING
Rozzano
Japan
Research Site
RECRUITING
Bunkyō City
Research Site
RECRUITING
Fukuyama-shi
Research Site
RECRUITING
Kobe
Research Site
RECRUITING
Kurume-shi
Research Site
RECRUITING
Kyoto
Research Site
RECRUITING
Kyoto
Research Site
RECRUITING
Osaka
Research Site
RECRUITING
Sakaishi
Research Site
RECRUITING
Shinjuku-ku
Research Site
RECRUITING
Wakayama
Research Site
RECRUITING
Yokohama
Republic of Korea
Research Site
RECRUITING
Cheongju-si
Research Site
RECRUITING
Namdong-gu
Research Site
RECRUITING
Seongnam-si
Research Site
RECRUITING
Seoul
Research Site
RECRUITING
Seoul
Research Site
RECRUITING
Seoul
Research Site
RECRUITING
Seoul
Research Site
RECRUITING
Suwon
Research Site
RECRUITING
Suwon
Singapore
Research Site
RECRUITING
Singapore
Research Site
RECRUITING
Singapore
Spain
Research Site
NOT_YET_RECRUITING
A Coruña
Research Site
NOT_YET_RECRUITING
Madrid
Research Site
NOT_YET_RECRUITING
Málaga
Research Site
NOT_YET_RECRUITING
Manresa
Research Site
NOT_YET_RECRUITING
Santander
Research Site
NOT_YET_RECRUITING
Valencia
Taiwan
Research Site
RECRUITING
Liuying
Research Site
RECRUITING
Taichung
Research Site
RECRUITING
Taichung
Research Site
RECRUITING
Tainan
Research Site
RECRUITING
Tainan
Research Site
RECRUITING
Taipei
Research Site
RECRUITING
Taipei
Research Site
RECRUITING
Taipei
Research Site
RECRUITING
Taoyuan
Thailand
Research Site
NOT_YET_RECRUITING
Bangkok
Research Site
NOT_YET_RECRUITING
Bangkok
Research Site
NOT_YET_RECRUITING
Bangkok
Research Site
NOT_YET_RECRUITING
Banphaeo
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date: 2025-08-07
Estimated Completion Date: 2029-04-06
Participants
Target number of participants: 278
Treatments
Experimental: Sub-study 1, investigate rilvegostomig± ramucirumab in 1L non-AGA NSCLC with PD-L1 ≥50%
Participants will receive rilvegostomig ± ramucirumab until RECIST 1.1-defined radiological progression, unacceptable toxicity, withdrawal of consent, or other discontinuation criterion
Experimental: Sub-study 2, investigate rilvegostomig + ramucirumab in 1L non-AGA NSCLC with PD-L1 1-49%
Participants will receive rilvegostomig + ramucirumab until RECIST 1.1-defined radiological progression, unacceptable toxicity, withdrawal of consent, or other discontinuation criterion
Experimental: Sub-study 3, investigate Dato-DXd + ramucirumab ± rilvegostomig in 2/3L AGA+ NSCLC
Participants will receive Dato-DXd + ramucirumab ± rilvegostomig until RECIST 1.1-defined radiological progression, unacceptable toxicity, withdrawal of consent, or other discontinuation criterion
Related Therapeutic Areas
Sponsors
Leads: AstraZeneca
Collaborators: Daiichi Sankyo