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Active, Not Recruiting

NCT Number: NCT05565378

A Platform Study of Novel Immunotherapy Combinations in Participants With Previously Untreated, Advanced/Metastatic Non-Small-Cell Lung Cancer

This study will monitor the safety of novel immunotherapy combinations 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

GSK Investigational Site, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)
  • No prior systemic therapy for their locally advanced or metastatic NSCLC
  • Provides a fresh tumor tissue sample or archival sample collected within 2 years prior to screening
  • PD-L1-high (TC/TPS >= 50%) tumor
  • Measurable disease based on RECIST 1.1, as determined by the investigator
  • Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
  • Adequate Baseline organ function
  • Female participants of childbearing potential must use adequate contraception

Exclusion criteria

  • Has NSCLC with a tumor that harbors any of the following molecular alterations: EGFR and /or ALK translocations mutations that are sensitive to available targeted inhibitor therapy, 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.
  • Had major surgery within 4 weeks or lung radiation of >30 Gy therapy within 6 months prior to the first dose of study intervention
  • Received prior therapy with any immune checkpoint inhibitors
  • 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 (clinical exceptions apply as per protocol)
  • Symptomatic, untreated, or actively progressing, brain metastases or any leptomeningeal disease (regardless of symptomatology, treatment status, or stability)
  • Autoimmune disease or syndrome that required systemic treatment within the past 2 years
  • Receiving systemic steroid therapy <= 3 days prior to first dose of study intervention or any form of immunosuppressive medication
  • Received any live vaccine <= 30 days prior to first dose of study intervention
  • Any history of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis
  • History or evidence of cardiac abnormalities
  • Current unstable liver or biliary disease
  • Severe infection within 4 weeks prior to the first dose of study intervention
  • Positive for tuberculosis, human immunodeficiency virus (HIV) infection, hepatitis B surface antigen, or hepatitis C
  • Has advanced, symptomatic, or visceral spread and is considered to be at imminent risk of life-threatening complications (including, but not limited to, massive uncontrolled effusions [e.g., pleural, pericardial, peritoneal])
  • Is currently participating in or has participated in a study of an investigational therapy within 4 weeks prior to the first dose of study intervention
  • Has a history of allogeneic tissue/stem cell transplant or solid organ transplant

Treatment and study plan

Pembrolizumab

Drug

Pembrolizumab will be administered.

Dostarlimab

Drug

Dostarlimab will be administered

Other names: GSK4057190

Belrestotug

Drug

Belrestotug will be administered.

Other names: EOS884448, GSK4428859A

Nelistotug

Drug

Nelistotug will be administered.

Other names: GSK6097608

Primary outcomes

  1. Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    Time frame: Up to 228 weeks

  2. Number of Participants with TEAEs or SAEs leading to dose modifications or treatment discontinuation

    Time frame: Up to 228 weeks

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Collaborators

  • iTeos Therapeutics

Registry information

Official study title

A Phase 2, Randomized, Open-label, Platform Study Utilizing a Master Protocol to Evaluate Novel Immunotherapy Combinations in Participants With Previously Untreated, Locally Advanced/Metastatic, Programmed Death Ligand 1-Selected Non-Small-Cell Lung Cancer

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Oct 4, 2022
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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