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 (57) 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
NOT_YET_RECRUITING
Atlanta
Maryland
Research Site
NOT_YET_RECRUITING
Baltimore
Texas
Research Site
NOT_YET_RECRUITING
Houston
Virginia
Research Site
NOT_YET_RECRUITING
Fairfax
Other Locations
Australia
Research Site
NOT_YET_RECRUITING
Nedlands
Research Site
NOT_YET_RECRUITING
Woodville
Canada
Research Site
NOT_YET_RECRUITING
Toronto
China
Research Site
NOT_YET_RECRUITING
Changsha
Research Site
NOT_YET_RECRUITING
Chengdu
Research Site
NOT_YET_RECRUITING
Deyang
Research Site
NOT_YET_RECRUITING
Dongguan
Research Site
NOT_YET_RECRUITING
Fuzhou
Research Site
NOT_YET_RECRUITING
Guangzhou
Research Site
RECRUITING
Guangzhou
Research Site
NOT_YET_RECRUITING
Hangzhou
Research Site
NOT_YET_RECRUITING
Linyi
Research Site
RECRUITING
Mianyang
Research Site
NOT_YET_RECRUITING
Nanchang
Research Site
RECRUITING
Nanchang
Research Site
RECRUITING
Shantou
Research Site
NOT_YET_RECRUITING
Shenyang
Research Site
RECRUITING
Wuhan
Research Site
NOT_YET_RECRUITING
Zhengzhou
Research Site
NOT_YET_RECRUITING
Zhengzhou
Research Site
NOT_YET_RECRUITING
Zhuhai
Japan
Research Site
NOT_YET_RECRUITING
Bunkyō City
Research Site
NOT_YET_RECRUITING
Kobe
Research Site
NOT_YET_RECRUITING
Kurume-shi
Research Site
NOT_YET_RECRUITING
Kyoto
Research Site
NOT_YET_RECRUITING
Osaka
Research Site
NOT_YET_RECRUITING
Sakaishi
Research Site
NOT_YET_RECRUITING
Shinjuku-ku
Research Site
NOT_YET_RECRUITING
Wakayama
Research Site
NOT_YET_RECRUITING
Yokohama
Republic of Korea
Research Site
NOT_YET_RECRUITING
Cheongju-si
Research Site
NOT_YET_RECRUITING
Namdong-gu
Research Site
NOT_YET_RECRUITING
Seongnam-si
Research Site
NOT_YET_RECRUITING
Seoul
Research Site
NOT_YET_RECRUITING
Seoul
Research Site
NOT_YET_RECRUITING
Seoul
Research Site
NOT_YET_RECRUITING
Seoul
Research Site
NOT_YET_RECRUITING
Suwon
Research Site
NOT_YET_RECRUITING
Suwon
Singapore
Research Site
NOT_YET_RECRUITING
Singapore
Taiwan
Research Site
NOT_YET_RECRUITING
Liuying
Research Site
NOT_YET_RECRUITING
Taichung
Research Site
NOT_YET_RECRUITING
Tainan City
Research Site
NOT_YET_RECRUITING
Taipei
Research Site
NOT_YET_RECRUITING
Taipei
Research Site
NOT_YET_RECRUITING
Taipei
Research Site
NOT_YET_RECRUITING
Taoyuan District
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 as assessed by the investigator, 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 as assessed by the investigator, unacceptable toxicity, withdrawal of consent, or other discontinuation criterion
Participants will receive Dato-DXd + ramucirumab ± rilvegostomig until RECIST 1.1-defined radiological progression as assessed by the investigator, unacceptable toxicity, withdrawal of consent, or other discontinuation criterion