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Clinical Trials in China / NCT06472076
Active, not recruiting Phase 3

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)

NCT06472076 · tracked via the Priya Life Science China tracker
Sponsor
GlaxoSmithKline
Phase
Phase 3
Started
2024-06-10
Last updated
2026-07-21

Condition(s) studied

Lung Cancer, Non-Small Cell

Investigational drug(s) / intervention(s)

Dostarlimab →Belrestotug →Pembrolizumab →Placebo

Dostarlimab: Dostarlimab will be administered.

Belrestotug: Belrestotug will be administered.

Pembrolizumab: Pembrolizumab will be administered.

Placebo: Placebo will be administered.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (108)

FacilityCityRegionStatus
GSK Investigational Site Ocala Florida
GSK Investigational Site Honolulu Hawaii
GSK Investigational Site Lexington Kentucky
GSK Investigational Site Lexington Kentucky
GSK Investigational Site Omaha Nebraska
GSK Investigational Site Nashville Tennessee
GSK Investigational Site Fort Worth Texas
GSK Investigational Site Olympia Washington
GSK Investigational Site Buenos Aires Argentina
GSK Investigational Site Cipoletti Rio Negro Argentina
GSK Investigational Site Ciudad Autonoma de Buenos Aire Argentina
GSK Investigational Site Ciudad Autonoma de Bueno Argentina
GSK Investigational Site Córdoba Argentina
GSK Investigational Site Florida Argentina
GSK Investigational Site Mendoza Argentina
GSK Investigational Site Rosario Argentina
GSK Investigational Site San Miguel de Tucumán Argentina
GSK Investigational Site Hasselt Belgium
GSK Investigational Site Mont Gaston Belgium
GSK Investigational Site Barretos Brazil
GSK Investigational Site Belém Brazil
GSK Investigational Site CuritibaPR Brazil
GSK Investigational Site Florianópolis Brazil
GSK Investigational Site Fortaleza Brazil
GSK Investigational Site Londrina Brazil
GSK Investigational Site Porto VelhoRondOnia Brazil
GSK Investigational Site Salvador Brazil
GSK Investigational Site SAo JosE Do Rio PretoSP Brazil
GSK Investigational Site São Paulo Brazil
GSK Investigational Site Vitória Brazil
GSK Investigational Site Haskovo Bulgaria
GSK Investigational Site Plovdiv Bulgaria
GSK Investigational Site Halifax Nova Scotia
GSK Investigational Site Chengdu China
GSK Investigational Site Hangzhou China
GSK Investigational Site Hangzhou China
GSK Investigational Site Hefei China
GSK Investigational Site Nanjing China
GSK Investigational Site Shanghai China
GSK Investigational Site Kuopio Finland

+ 68 more sites — see the full list on the official registry below.

On this site

📄 Keytruda (pembrolizumab) drug profile →

More GlaxoSmithKline trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06472076 on ClinicalTrials.gov ↗ ← All trials in China