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Monoclonal Antibodies
Belrestotug + Dostarlimab for Lung Cancer
Phase 3
Recruiting
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Has a histologically or cytologically confirmed diagnosis of locally advanced, unresectable NSCLC or Metastatic NSCLC
Has not received prior systemic therapy for their locally advanced or metastatic NSCLC
Must not have
Has NSCLC with a tumor that harbors specific molecular alterations
Has any history of specific pulmonary conditions
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 5 years
Awards & highlights
Summary
This trial aims to see if a new combination of drugs, dostarlimab and belrestotug, is more effective and safe than the current standard treatment, pembrolizumab, for
Who is the study for?
This trial is for adults with advanced or metastatic non-small-cell lung cancer that has high levels of PD-L1 and hasn't been treated before. Participants must be able to undergo medical procedures and treatments as part of the study.
What is being tested?
The trial tests if combining dostarlimab with belrestotug improves survival compared to pembrolizumab with a placebo in patients with specific lung cancer. It measures how long patients live without their disease getting worse and overall survival.
What are the potential side effects?
Possible side effects include immune-related reactions, infusion-related symptoms, fatigue, skin issues, nausea, and potential risks associated with immunotherapy drugs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lung cancer is advanced and cannot be removed by surgery.
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I haven't had systemic therapy for my advanced lung cancer.
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My tumor is highly PD-L1 positive.
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I am fully active or can carry out light work.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My lung cancer has specific genetic changes.
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I have a history of lung conditions.
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I have fluid buildup in my abdomen, chest, or around my heart that causes symptoms.
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I have not had a severe infection or tuberculosis in the last 4 weeks.
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I have had a transplant of tissue, stem cells, or an organ.
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I have been treated with drugs that boost the immune system.
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I have been treated for an autoimmune disease in the last 2 years.
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I had surgery less than 4 weeks ago or lung radiation over 30 Gy in the last 6 months and haven't recovered from side effects.
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I have brain metastases or leptomeningeal disease that is untreated or getting worse.
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I have not had any cancer other than my current type in the last 5 years.
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I have an active inflammatory bowel condition.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Survival (OS)
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1) by Blinded independent central review (BICR)
Secondary outcome measures
Duration of Response (DOR)
Molecular Response Rate (MRR)
Objective Response Rate (ORR)
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Dostarlimab plus belrestotugExperimental Treatment2 Interventions
Group II: Pembrolizumab plus placeboActive Control2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dostarlimab
2020
Completed Phase 3
~1760
Find a Location
Who is running the clinical trial?
GlaxoSmithKlineLead Sponsor
4,788 Previous Clinical Trials
8,175,807 Total Patients Enrolled
iTeos TherapeuticsIndustry Sponsor
9 Previous Clinical Trials
1,380 Total Patients Enrolled
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