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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 below

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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:

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 5 years for reporting.

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 more

Trial 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

0 / 15Eligibility criteria met

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

~667 spots leftby Sep 2028

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