RecruitingPhase 1Phase 2NCT04995523

A Study of AZD2936 Anti-TIGIT/Anti-PD-1 Bispecific Antibody in Participants With Advanced or Metastatic NSCLC

Phase I/II, Open-label, Dose Escalation and Dose Expansion Study to Evaluate Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of AZD2936 Anti-TIGIT/Anti-PD-1 Bispecific Antibody in Participants With Advanced or Metastatic NSCLC

Sponsor

AstraZeneca

Enrollment

210 participants

Start Date

Sep 14, 2021

Study Type

INTERVENTIONAL

Conditions

Non-Small-Cell Lung Carcinoma

Summary

This is a Phase I/II study designed to evaluate if experimental anti-TIGIT/anti-PD-1 bispecific antibody rilvegostomig (AZD2936) is safe, tolerable and efficacious in participants with Advanced or Metastatic Non-small Cell Lung Cancer.

Eligibility

Min Age: 18 YearsMax Age: 130 Years

Plain Language Summary

Simplified for easier understanding

This study tests AZD2936, a new bispecific antibody that blocks two immune checkpoints (TIGIT and PD-1) at the same time, in patients with advanced or metastatic non-small cell lung cancer (NSCLC) that cannot be surgically removed. **You may be eligible if...** - You are 18 or older with stage III or IV non-small cell lung cancer that cannot be surgically cured - Your tumor has been tested for PD-L1 expression - Depending on the study group: either your cancer has progressed after prior immunotherapy, or you have not had prior immunotherapy - You are in good health (ECOG 0–1) with at least 12 weeks life expectancy - You have at least one measurable area of disease **You may NOT be eligible if...** - Your cancer has specific genetic mutations (EGFR, ALK, ROS1, NTRK, BRAF) for which targeted therapies are available - You have had prior anti-TIGIT therapy - You have active brain metastases with symptoms - You have had a blood clot (thromboembolic event) within 3 months - You have had another invasive cancer within 2 years 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

DRUGAZD2936

Anti-TIGIT/Anti-PD-1 Bispecific Antibody

Locations(48)

Research Site

Seoul, South Korea

Research Site

Rio de Janeiro, Brazil

Research Site

Seoul, South Korea

Research Site

Orange, California, United States

Research Site

Seoul, South Korea

Research Site

Fairfax, Virginia, United States

Research Site

Anderlecht, Belgium

Research Site

Leuven, Belgium

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Florianópolis, Brazil

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Natal, Brazil

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Porto Alegre, Brazil

Research Site

Barcelona, Spain

Research Site

Baltimore, Maryland, United States

Research Site

Chengdu, China

Research Site

Dijon, France

Research Site

Toulouse, France

Research Site

Tbilisi, Georgia

Research Site

Kashiwa, Japan

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Niigata, Japan

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Sendai, Japan

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Kuching, Malaysia

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Chisinau, Moldova

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Groningen, Netherlands

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Leiden, Netherlands

Research Site

Utrecht, Netherlands

Research Site

Taichung, Taiwan

Research Site

Taichung, Taiwan

Research Site

Tainan, Taiwan

Research Site

Chanthaburi, Thailand

Research Site

Muang, Thailand

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Leicester, United Kingdom

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Madrid, Spain

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Wuhan, China

Research Site

Bangkok, Thailand

Research Site

Houston, Texas, United States

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Rochester, Minnesota, United States

Research Site

Taipei, Taiwan

Research Site

Chongqing, China

Research Site

Copenhagen, Denmark

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Singapore, Singapore

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Tokyo, Japan

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Manchester, United Kingdom

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São Paulo, Brazil

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Kuala Lumpur, Malaysia

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Chicago, Illinois, United States

Research Site

Melbourne, Australia

Research Site

Madrid, Spain

Research Site

Taipei, Taiwan

View Full Details on ClinicalTrials.gov

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NCT04995523

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