Last updated 6 months ago
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)
1000 patients around the world
Available in Panama, Spain, Brazil, Argentina, Mexico
GlaxoSmithKline
6Research sites
1000Patients around the world
This study is for people with
Lung cancer
Non-small cell lung carcinoma
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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:Epidermal growth factor receptor (EGFR) mutations that are sensitive to available targeted inhibitor therapy.Has NSCLC with a tumor that harbors any of the following molecular alterations: Anaplastic lymphoma kinase (ALK) translocations that are sensitive to available targeted inhibitor therapy.Has NSCLC with a tumor that harbors any of the following molecular alterations: 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 progressing 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.
Sites
Centro Médico Privado CEMAIC - Córdoba
Recruiting
Centro de Investigaciones Metabólicas (CINME) S.A. - CABA, Buenos Aires
Recruiting
CEMER Centro Médico de Enfermedades Respiratorias - Vicente Lopez
Recruiting
Centro Oncológico de Integración Regional C.O.I.R.
Recruiting
Sanatorio 9 de Julio - Tucumán
Recruiting
Centro Oncológico Korben
Recruiting
SponsorGlaxoSmithKline
Conditions
Non-small cell lung carcinoma
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06472076
