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PD-L1 Inhibitor

Novel Immunotherapy Combinations for Lung Cancer

Phase 2

Recruiting

Research Sponsored by GlaxoSmithKline

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1

Histologically or cytologically confirmed diagnosis of locally advanced unresectable NSCLC not eligible for curative surgery and/or definitive radiotherapy with or without chemotherapy or metastatic NSCLC (squamous or non squamous)

Must not have

Has a history of allogeneic tissue/stem cell transplant or solid organ transplant

Received prior therapy with any immune checkpoint inhibitors

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will study two new immunotherapy drugs to see if they can safely and effectively treat lung cancer.

Who is the study for?

This trial is for adults with advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) that hasn't been treated before and has high PD-L1 levels. Participants should be in good physical condition, not have had certain lung diseases or recent major surgeries, and must not be taking immunosuppressive drugs. Smokers need to have smoked more than 100 cigarettes in their lifetime.

What is being tested?

The study tests new combinations of immunotherapy drugs Belrestotug, GSK6097608, Pembrolizumab, and Dostarlimab against monotherapy in NSCLC patients with high PD-L1 expression. It aims to see how well these treatments work and what effects they have on the body.

What are the potential side effects?

Potential side effects may include immune-related reactions affecting different organs, infusion-related symptoms like fever or chills, fatigue, changes in blood test results indicating organ function issues, increased risk of infections due to immune system suppression.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or restricted in physically strenuous activity but can do light work.

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My lung cancer cannot be removed by surgery or cured with radiation.

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My tumor has a high PD-L1 level (50% or more).

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I haven't had any drug treatments for my advanced lung cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a transplant of tissue, stem cells, or an organ from another person.

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I have been treated with drugs that boost the immune system.

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I have brain metastases or leptomeningeal disease that is untreated or getting worse.

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I am currently taking medication that weakens my immune system.

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My cancer has specific genetic changes like EGFR mutations or ALK translocations.

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My cancer has spread significantly and poses an immediate threat to my life.

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I have a history of lung scarring or inflammation not caused by infections.

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My liver condition is stable.

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I have been treated for an autoimmune disease in the last 2 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective Response Rate (ORR)

Secondary study objectives

Duration of response (DOR)

Maximum Observed Serum Concentration (Cmax) for GSK6097608

Maximum Observed Serum Concentration (Cmax) for belrestotug

+12 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups

Experimental Treatment

Active Control

Group I: Substudy 2Experimental Treatment3 Interventions

Participants will be administered an IV infusion of dostarlimab in a fixed dose followed by an IV infusion of belrestotug along with IV infusion of GSK6097608 in a fixed dose.

Group II: Substudy 1CExperimental Treatment2 Interventions

Participants will be administered an IV infusion of dostarlimab in a fixed dose followed by an IV infusion of belrestotug in a fixed dose (Dose C).

Group III: Substudy 1BExperimental Treatment2 Interventions

Participants will be administered an IV infusion of dostarlimab in a fixed dose followed by an IV infusion of belrestotug in a fixed dose (Dose B).

Group IV: Substudy 1AExperimental Treatment2 Interventions

Participants will be administered an IV infusion of dostarlimab in a fixed dose followed by an IV infusion of belrestotug in a fixed dose (Dose A).

Group V: Dostarlimab MonotherapyExperimental Treatment1 Intervention

Participants will be administered an IV infusion of dostarlimab as monotherapy in a fixed dose.

Group VI: Pembrolizumab MonotherapyActive Control1 Intervention

Participants will be administered an intravenous (IV) infusion of pembrolizumab as monotherapy in a fixed dose.

Treatment

First Studied