RecruitingPhase 2NCT07098338

A Study of Novel Combinations in Non-Small Cell Lung Cancer (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)

Sponsor

AstraZeneca

Enrollment

278 participants

Start Date

Aug 7, 2025

Study Type

INTERVENTIONAL

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing several new drug combinations for people with advanced non-small cell lung cancer (NSCLC). There are three sub-studies based on whether your tumor has certain gene mutations and how much of a protein called PD-L1 it expresses. Researchers are looking for safer, more effective treatment options beyond current standard care. **You may be eligible if...** - You are 18 or older - You have advanced or metastatic NSCLC confirmed by biopsy - You have at least one measurable tumor on imaging - Your daily functioning is good (ECOG performance status 0 or 1) - Your organ function is adequate - You have a life expectancy of at least 12 weeks - (Sub-study 1 & 2): Your tumor has PD-L1 expression and no EGFR or ALK mutations - (Sub-study 3): Your tumor has a specific gene alteration (AGA) and has progressed on targeted therapy **You may NOT be eligible if...** - You have active autoimmune disease - You have unstable brain metastases - You have active HIV, hepatitis B or C, or tuberculosis - You have uncontrolled heart disease - You have received prior immunotherapy (sub-studies 1 & 2) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRilvegostomig

Rilvegostomig will be administered as IV infusion.

DRUGRamucirumab

Ramucirumab will be administered as IV infusion.

DRUGDato-DXd

Dato-DXd will be administered as IV infusion.

Locations(64)

Research Site

Santa Monica, California, United States

Research Site

Santa Rosa, California, United States

Research Site

Atlanta, Georgia, United States

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Baltimore, Maryland, United States

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Houston, Texas, United States

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Fairfax, Virginia, United States

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Heidelberg, Australia

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Nedlands, Australia

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Woodville, Australia

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Toronto, Ontario, Canada

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Changsha, China

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Chengdu, China

Research Site

Deyang, China

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Dongguan, China

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Fuzhou, China

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Guangzhou, China

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Guangzhou, China

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Hangzhou, China

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Hefei, China

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Linyi, China

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Mianyang, China

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Nanchang, China

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Nanchang, China

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Shantou, China

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Shenyang, China

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Wuhan, China

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Zhengzhou, China

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Zhengzhou, China

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Zhuhai, China

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Bunkyō City, Japan

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Fukuyama-shi, Japan

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Kobe, Japan

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Kurume-shi, Japan

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Kyoto, Japan

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Kyoto, Japan

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Osaka, Japan

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Sakaishi, Japan

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Shinjuku-ku, Japan

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Wakayama, Japan

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Yokohama, Japan

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Singapore, Singapore

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Singapore, Singapore

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Cheongju-si, South Korea

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Namdong-gu, South Korea

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Seongnam-si, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Suwon, South Korea

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Suwon, South Korea

Research Site

Liuying, Taiwan

Research Site

Taichung, Taiwan

Research Site

Taichung, Taiwan

Research Site

Tainan, Taiwan

Research Site

Tainan, Taiwan

Research Site

Taipei, Taiwan

Research Site

Taipei, Taiwan

Research Site

Taipei, Taiwan

Research Site

Taoyuan, Taiwan

Research Site

Bangkok, Thailand

Research Site

Bangkok, Thailand

Research Site

Bangkok, Thailand

Research Site

Banphaeo, Thailand

View Full Details on ClinicalTrials.gov

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NCT07098338