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Evaluating a new treatment for high PD-L1 non-small cell lung cancer

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)

PHASE3 · GlaxoSmithKline · NCT06472076

This study is testing a new combination treatment for patients with advanced non-small cell lung cancer that has high levels of PD-L1 to see if it works better than the standard therapy.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment1000 (estimated)
Ages18 Years and up
SexAll
SponsorGlaxoSmithKline (industry)
Drugs / interventionschemotherapy, radiation, dostarlimab, pembrolizumab
Locations188 sites (Ocala, Florida and 187 other locations)
Trial IDNCT06472076 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the effectiveness and safety of a combination therapy using dostarlimab and belrestotug compared to pembrolizumab and placebo in patients with previously untreated, unresectable, locally advanced or metastatic non-small cell lung cancer (NSCLC) that expresses high levels of PD-L1. Participants will be monitored for progression-free survival (PFS) and overall survival (OS) to determine if the new treatment offers significant benefits over the standard therapy. The study involves administering these medications to eligible patients and analyzing their responses over time.

Who should consider this trial

Good fit: Ideal candidates are adults with locally advanced or metastatic NSCLC who have not received prior systemic therapy and have tumors expressing high levels of PD-L1.

Not a fit: Patients with specific molecular alterations such as EGFR mutations or ALK translocations may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve survival rates and quality of life for patients with high PD-L1 non-small cell lung cancer.

How similar studies have performed: Other studies have shown promising results with similar immunotherapy approaches, indicating potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion 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

Exclusion Criteria:

* 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.

Where this trial is running

Ocala, Florida and 187 other locations

+138 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

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

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.