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)
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)
Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) — Up to approximately 138 weeks
Number of Participants with TEAEs or SAEs leading to dose withdrawals or treatment discontinuation — Up to approximately 138 weeks
Trial sites (108)
Facility
City
Region
Status
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.
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.
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