351 Participants Needed

Novel Immunotherapy Combinations for Lung Cancer

Recruiting at 143 trial locations
UG
EG
Overseen ByEU GSK Clinical Trials Call Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This study will evaluate the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (PDy) of novel immunotherapy combinations compared with immunotherapy monotherapy in participants with Programmed death ligand-1 (PD L-1) high (Tumor cells \[TC\]/ Tumor proportion score \[TPS\] \>= 50%), previously untreated, unresectable, locally advanced or metastatic non-small cell lung cancer (NSCLC). Drug name mentioned as Belrestotug, GSK4428859A, and EOS884448 are all interchangeable for the same compound. In the rest of the document, the drug will be referred to as Belrestotug.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on systemic steroid therapy or any immunosuppressive medication, you must stop at least 3 days before the first dose of the study drug.

Is the novel immunotherapy combination for lung cancer safe for humans?

The safety profiles of dostarlimab and pembrolizumab, when combined with chemotherapy, are similar and have been studied in patients with metastatic non-squamous non-small cell lung cancer, showing that they are generally safe for human use.12345

What makes the drug combination of Dostarlimab, GSK4428859A, and Pembrolizumab unique for lung cancer?

This drug combination is unique because it involves novel immunotherapy agents like Dostarlimab and Pembrolizumab, which are both PD-1 inhibitors (drugs that block a protein on immune cells to help them attack cancer cells), and GSK4428859A, which may offer a new approach to treating lung cancer by potentially enhancing the immune response against tumors.12346

What data supports the effectiveness of the drug combination including Dostarlimab and Pembrolizumab for lung cancer?

Research shows that Pembrolizumab significantly improves survival in advanced lung cancer compared to traditional chemotherapy. Additionally, Dostarlimab has shown similar effectiveness to Pembrolizumab in lung cancer, suggesting that both drugs are potent in treating this condition.35789

Who Is on the Research Team?

GC

GSK Clinical Trials

Principal Investigator

GlaxoSmithKline

Are You a Good Fit for This Trial?

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.

Inclusion 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.
My lung cancer cannot be removed by surgery or cured with radiation.
See 5 more

Exclusion Criteria

I am currently taking medication that weakens my immune system.
I have been treated with drugs that boost the immune system.
I have brain metastases or leptomeningeal disease that is untreated or getting worse.
See 14 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive novel immunotherapy combinations or monotherapy for advanced/metastatic non-small-cell lung cancer

Up to 24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

  • Dostarlimab
  • GSK4428859A
  • Pembrolizumab
Trial Overview 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.
How Is the Trial Designed?
6Treatment groups
Experimental Treatment
Active Control
Group I: Substudy 2AExperimental Treatment3 Interventions
Group II: Substudy 1CExperimental Treatment2 Interventions
Group III: Substudy 1BExperimental Treatment2 Interventions
Group IV: Substudy 1AExperimental Treatment2 Interventions
Group V: Dostarlimab MonotherapyExperimental Treatment1 Intervention
Group VI: Pembrolizumab MonotherapyActive Control1 Intervention

Dostarlimab is already approved in European Union, United States for the following indications:

🇪🇺
Approved in European Union as Jemperli for:
🇺🇸
Approved in United States as Jemperli for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

GlaxoSmithKline

Lead Sponsor

Trials
4,834
Recruited
8,389,000+
Headquarters
London, UK
Known For
Vaccines & Medicines
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Dame Emma Walmsley profile image

Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

Dr. Hal Barron profile image

Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School

iTeos Therapeutics

Industry Sponsor

Trials
11
Recruited
2,500+

Published Research Related to This Trial

In the KEYNOTE-024 study involving 305 patients with untreated advanced non-small-cell lung cancer, pembrolizumab significantly improved overall survival (OS) compared to platinum-based chemotherapy, with a median OS of 30.0 months versus 14.2 months for chemotherapy.
Pembrolizumab also had a better safety profile, with fewer treatment-related severe adverse events (31.2% for pembrolizumab vs. 53.3% for chemotherapy), indicating it is a safer option for patients.
Updated Analysis of KEYNOTE-024: Pembrolizumab Versus Platinum-Based Chemotherapy for Advanced Non-Small-Cell Lung Cancer With PD-L1 Tumor Proportion Score of 50% or Greater.Reck, M., Rodríguez-Abreu, D., Robinson, AG., et al.[2022]
Dostarlimab, an anti-PD-1 monoclonal antibody, has been shown to be equipotent to pembrolizumab in suppressing PD-1 activity, with an estimated effective concentration of 1.95 μg/ml based on data from the GARNET trial.
The recommended dosing regimen for dostarlimab is 500 mg every 3 weeks for 4 cycles, followed by 1000 mg every 6 weeks, which supports its use as a potent treatment option for patients with recurrent or advanced mismatch repair-deficient solid tumors.
Comparative analysis of PD-1 target engagement of dostarlimab and pembrolizumab in advanced solid tumors using ex vivo IL-2 stimulation data.Austin, D., Melhem, M., Gandhi, Y., et al.[2023]
In the PERLA trial involving patients with metastatic non-squamous NSCLC, the combination of dostarlimab and chemotherapy (DCT) showed a higher overall response rate (45%) compared to pembrolizumab and chemotherapy (PCT) (39%), particularly in PD-L1-positive subgroups.
Dostarlimab also demonstrated improved median progression-free survival (8.8 months) and median overall survival (19.4 months) compared to pembrolizumab (6.7 months and 15.9 months, respectively), indicating its potential as an effective first-line treatment option.
Dostarlimab or pembrolizumab plus chemotherapy in previously untreated metastatic non-squamous non-small cell lung cancer: the randomized PERLA phase II trial.Lim, SM., Peters, S., Ortega Granados, AL., et al.[2023]

Citations

Updated Analysis of KEYNOTE-024: Pembrolizumab Versus Platinum-Based Chemotherapy for Advanced Non-Small-Cell Lung Cancer With PD-L1 Tumor Proportion Score of 50% or Greater. [2022]
Comparative analysis of PD-1 target engagement of dostarlimab and pembrolizumab in advanced solid tumors using ex vivo IL-2 stimulation data. [2023]
Dostarlimab or pembrolizumab plus chemotherapy in previously untreated metastatic non-squamous non-small cell lung cancer: the randomized PERLA phase II trial. [2023]
Neoadjuvant anti-programmed death-1 immunotherapy by pembrolizumab in resectable non-small cell lung cancer: First clinical experience. [2022]
Pembrolizumab for the treatment of thoracic malignancies: current landscape and future directions. [2017]
New Drug for Mismatch Repair Deficient Endometrial Cancer and Solid Tumors. [2023]
Dostarlimab: A Review. [2022]
Dostarlimab: First Approval. [2021]
Safety and Efficacy of Dostarlimab in Patients With Recurrent/Advanced Non-small Cell Lung Cancer: Results from Cohort E of the Phase I GARNET Trial. [2023]
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