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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Select...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rate (ORR)
Secondary outcome measures
Duration of response (DOR)
Maximum Observed Serum Concentration (Cmax) for GSK6097608
Maximum Observed Serum Concentration (Cmax) for belrestotug
+13 moreTrial 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
Drug Approval Stage
How many patients have taken this drug
Dostarlimab
2020
Completed Phase 2
~1000
Find a Location
Who is running the clinical trial?
GlaxoSmithKlineLead Sponsor
4,755 Previous Clinical Trials
8,070,516 Total Patients Enrolled
iTeos TherapeuticsIndustry Sponsor
7 Previous Clinical Trials
1,097 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,595 Previous Clinical Trials
6,143,630 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- The doctor can see and measure your disease using specific guidelines.I am fully active or restricted in physically strenuous activity but can do light work.I am currently taking medication that weakens my immune system.My lung cancer cannot be removed by surgery or cured with radiation.My tumor has a high PD-L1 level (50% or more).I have been treated with drugs that boost the immune system.I have brain metastases or leptomeningeal disease that is untreated or getting worse.I have had a transplant of tissue, stem cells, or an organ from another person.I haven't had major surgery in the last 4 weeks or significant lung radiation in the past 6 months.I have not received a live vaccine in the last 30 days.You have smoked fewer than 100 cigarettes in your entire life.My cancer has specific genetic changes like EGFR mutations or ALK translocations.My cancer has spread significantly and poses an immediate threat to my life.I have a history of lung scarring or inflammation not caused by infections.I haven't had any cancer other than the one I'm being treated for in the last 5 years.I have had heart problems in the last 6 months.My liver condition is stable.I have not had a severe infection in the last 4 weeks.You have tuberculosis, HIV, hepatitis B, or hepatitis C.I haven't had any drug treatments for my advanced lung cancer.My organs are functioning well.I am using reliable birth control methods.I have been treated for an autoimmune disease in the last 2 years.I can provide a recent tumor sample taken within the last 2 years.
Research Study Groups:
This trial has the following groups:- Group 1: Substudy 2
- Group 2: Pembrolizumab Monotherapy
- Group 3: Dostarlimab Monotherapy
- Group 4: Substudy 1A
- Group 5: Substudy 1B
- Group 6: Substudy 1C
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are engaging in the trial?
"Yes, clinicaltrials.gov denotes that this study is currently enlisting subjects. It was first published on October 14th 2022 and has been updated as recently as June 5th 2023. 300 participants are being sought from 23 distinct locations."
Answered by AI
Are there multiple facilities actively conducting this experiment?
"The trial is currently operating at 23 sites, including Ciudad Autonoma de Buenos Aires, Edegem and Athens. To reduce the need for travel if you join the study, it might be beneficial to select a clinic that's closest to your location."
Answered by AI
Has Substudy 1C received FDA authorization?
"Substudy 1C was assessed to be a 2 in terms of safety due to the Phase 2 data that is available, which supports its security but lacks any evidence of efficacy."
Answered by AI
Are there any current openings for participants in this experiment?
"Affirmative. Clinicaltrials.gov states that the trial was first published on October 14th 2022 and recently updated June 5th 2023, with an increasing requirement for 300 participants from 23 locations across America."
Answered by AI
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