ACTIVE_NOT_RECRUITING

A Study of Belrestotug Plus Dostarlimab Compared With Placebo Plus Pembrolizumab in Previously Untreated Participants With Programmed Death Ligand 1 (PD-L1) High Non-small-cell Lung Cancer (NSCLC)

Conditions

Lung Cancer, Non-Small Cell Belrestotug GSK4428859A EOS-448 Dostarlimab Pembrolizumab PD-L1 selected NSCLC

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this clinical trial is to evaluate the safety and tolerability profile of dostarlimab in combination with belrestotug when compared with pembrolizumab and placebo in participants with previously untreated, unresectable, locally advanced or metastatic PD-L1 high NSCLC.

Official Title

A Randomized, Multicenter, Double-blind, Phase 3 Study to Investigate the Safety and Efficacy of Belrestotug in Combination With Dostarlimab Compared With Placebo in Combination With Pembrolizumab in Participants With Previously Untreated, Unresectable, Locally Advanced or Metastatic PD-L1 Selected Non-small Cell Lung Cancer (GALAXIES Lung-301)

Quick Facts

Study Start:2024-06-10

Study Completion:2027-02-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06472076

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Has a 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 * Has not received prior systemic therapy for their locally advanced or metastatic NSCLC. * Provides a fresh tumor tissue sample obtained at the time of or after the initial diagnosis of locally advanced or metastatic NSCLC. * Has a PD-L1-high (Tumor cells \[TC\] ≥50%) tumor * Has measurable disease (at least 1 target lesion) based on RECIST 1.1 * Has an Eastern Cooperative Oncology Group (ECOG) Performance status (PS) score of 0 or 1. * Has adequate organ function	* Has NSCLC with a tumor that harbors any of the following molecular alterations: 1. Epidermal growth factor receptor (EGFR) mutations that are sensitive to available targeted inhibitor therapy 2. Anaplastic lymphoma kinase (ALK) translocations that are sensitive to available targeted inhibitor therapy 3. Any other known genomic aberrations or oncogenic driver mutations for which a locally approved targeted therapy is available for first line treatment of locally advanced or metastatic NSCLC. * Has had surgery within 4 weeks of the first dose of study intervention and has not recovered from AEs (i.e., has any ongoing surgery-related events ≥ Grade 1)/complications related to surgery or has received lung radiation therapy of \>30 gray (Gy) within 6 months * Has received prior therapy with any immune checkpoint inhibitors, including antibodies or drugs targeting PD-(L)1, Cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), T cell immunoglobulin and ITIM domain (TIGIT), or other checkpoint pathways. * Has never smoked, defined as smoking \<100 tobacco cigarettes in a lifetime. * Has an invasive malignancy or history of invasive malignancy other than the disease under study within the last 5 years, with the exception of those with a negligible risk of metastasis or death and/or treated with expected curative outcome. * Has symptomatic, untreated, or actively progressin g brain metastases or leptomeningeal disease * Has autoimmune disease or syndrome (current or history thereof) that required systemic treatment within the past 2 years. * Has received any live vaccine within 30 days prior to first dose of study intervention. * Has any history of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis. * Has symptomatic ascites, pleural effusion, or pericardial effusion. * Has active inflammatory bowel disease * Has a history of significant acute or chronic cardiac diagnosis requiring intervention/treatment in the last 6 months. * Has severe infection or complication thereof 4 weeks prior to randomisation including active tuberculosis. * Has a history of allogeneic tissue/stem cell transplant or solid organ transplant.

Inclusion Criteria

Exclusion Criteria

* Has a 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
* Has not received prior systemic therapy for their locally advanced or metastatic NSCLC.
* Provides a fresh tumor tissue sample obtained at the time of or after the initial diagnosis of locally advanced or metastatic NSCLC.
* Has a PD-L1-high (Tumor cells \[TC\] ≥50%) tumor
* Has measurable disease (at least 1 target lesion) based on RECIST 1.1
* Has an Eastern Cooperative Oncology Group (ECOG) Performance status (PS) score of 0 or 1.
* Has adequate organ function

* Has NSCLC with a tumor that harbors any of the following molecular alterations:
1. Epidermal growth factor receptor (EGFR) mutations that are sensitive to available targeted inhibitor therapy
2. Anaplastic lymphoma kinase (ALK) translocations that are sensitive to available targeted inhibitor therapy
3. Any other known genomic aberrations or oncogenic driver mutations for which a locally approved targeted therapy is available for first line treatment of locally advanced or metastatic NSCLC.
* Has had surgery within 4 weeks of the first dose of study intervention and has not recovered from AEs (i.e., has any ongoing surgery-related events ≥ Grade 1)/complications related to surgery or has received lung radiation therapy of \>30 gray (Gy) within 6 months
* Has received prior therapy with any immune checkpoint inhibitors, including antibodies or drugs targeting PD-(L)1, Cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), T cell immunoglobulin and ITIM domain (TIGIT), or other checkpoint pathways.
* Has never smoked, defined as smoking \<100 tobacco cigarettes in a lifetime.
* Has an invasive malignancy or history of invasive malignancy other than the disease under study within the last 5 years, with the exception of those with a negligible risk of metastasis or death and/or treated with expected curative outcome.
* Has symptomatic, untreated, or actively progressin g brain metastases or leptomeningeal disease
* Has autoimmune disease or syndrome (current or history thereof) that required systemic treatment within the past 2 years.
* Has received any live vaccine within 30 days prior to first dose of study intervention.
* Has any history of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis.
* Has symptomatic ascites, pleural effusion, or pericardial effusion.
* Has active inflammatory bowel disease
* Has a history of significant acute or chronic cardiac diagnosis requiring intervention/treatment in the last 6 months.
* Has severe infection or complication thereof 4 weeks prior to randomisation including active tuberculosis.
* Has a history of allogeneic tissue/stem cell transplant or solid organ transplant.

Contacts and Locations

Study Locations (Sites)

GSK Investigational Site

Ocala, Florida, 34474

United States

GSK Investigational Site

Honolulu, Hawaii, 96819

United States

GSK Investigational Site

Lexington, Kentucky, 40503

United States

GSK Investigational Site

Lexington, Kentucky, 40509

United States

GSK Investigational Site

Ann Arbor, Michigan, 48106

United States

GSK Investigational Site

Omaha, Nebraska, 68114

United States

GSK Investigational Site

Nashville, Tennessee, 37203

United States

GSK Investigational Site

Fort Worth, Texas, 76104

United States

GSK Investigational Site

Olympia, Washington, 98506

United States

Collaborators and Investigators

Sponsor: GlaxoSmithKline

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-10

Study Completion Date2027-02-02

Study Record Updates

Study Start Date2024-06-10

Study Completion Date2027-02-02

Terms related to this study

Keywords Provided by Researchers

Belrestotug
GSK4428859A
EOS-448
Dostarlimab
Pembrolizumab
PD-L1 selected NSCLC

Additional Relevant MeSH Terms

Lung Cancer, Non-Small Cell