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)
NCT Number: NCT06472076
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Lung Cancer, Non-Small Cell
Interventions: BIOLOGICAL: Dostarlimab|BIOLOGICAL: Belrestotug|BIOLOGICAL: Pembrolizumab|DRUG: Placebo
Sponsor: GlaxoSmithKline
Collaborators: iTeos Therapeutics
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-10
Completion Date: 2029-09-19
Locations: GSK Investigational Site, Ciudad Autonoma de Buenos Aires, Buenos Aires, 1425, Argentina|GSK Investigational Site, Florida, Buenos Aires, 1602, Argentina|GSK Investigational Site, Cipoletti, Rio Negro, Río Negro, R8324CVE, Argentina|GSK Investigational Site, Rosario, Santa Fe, S2002KDT, Argentina|GSK Investigational Site, Rosario, Santa Fe, S2002, Argentina|GSK Investigational Site, San Miguel de Tucumán, Tucumán, T4000, Argentina|GSK Investigational Site, Buenos Aires, C1426AGE, Argentina|GSK Investigational Site, Ciudad Autonoma de Buenos Aires, C1056ABI, Argentina|GSK Investigational Site, Cordoba, 5000, Argentina|GSK Investigational Site, Mendoza, M5500AYB, Argentina|GSK Investigational Site, Gent, 9000, Belgium|GSK Investigational Site, Hasselt, 3500, Belgium|GSK Investigational Site, Namur, 5000, Belgium|GSK Investigational Site, Salvador, Bahia, 40414-120, Brazil|GSK Investigational Site, Fortaleza, Ceará, 60336-232, Brazil|GSK Investigational Site, Vitória, Espírito 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Summary:
The goal of this clinical trial is to evaluate the efficacy and safety 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. Researchers will compare belrestotug plus dostarlimab with pembrolizumab plus placebo to see if there is meaningful improvement in progression free survival (PFS) and overall survival (OS).

Primary Outcome Measures: Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1) by Blinded independent central review (BICR), PFS as assessed per RECIST v1.1 by BICR is time from date of randomization to date of first documented progressive disease (PD) or death due to any cause, whichever comes first., Up to approximately 5 years|Overall Survival (OS), OS is defined as the time from the date of randomization to the date of death due to any cause., Up to approximately 5 years
Secondary Outcome Measures: Objective Response Rate (ORR), ORR is defined as the percentage of participants achieving confirmed complete response (CR) or confirmed partial response (PR) per RECIST version 1.1 by investigator assessment., Up to approximately 5 years|Molecular Response Rate (MRR), MRR is defined as the percentage of participants with a molecular response (i.e., a greater than or equal to 50% reduction in Circulating tumor deoxyribonucleic acid (ctDNA) levels relative to baseline)., Up to approximately 5 years|PFS per RECIST 1.1 by investigator assessment, PFS per RECIST 1.1 by investigator assessment, defined as the time from the date of randomization to the date of first documented PD or death due to any cause, whichever comes first., Up to approximately 5 years|Duration of Response (DOR), DOR per RECIST v 1.1 by investigator assessment, defined as the time from the date of first confirmed response (CR or PR) to the date of first documented PD or death due to any cause, whichever comes first., Up to approximately 5 years|Time to first subsequent therapy (TFST), TFST is defined as the time from the date of randomization to the date of the first subsequent anticancer therapy or death, whichever occurs first., Up to approximately 5 years|Number of Participants with Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs), Up to approximately 5 years|Number of Participants with TEAEs or SAEs leading to dose modifications or study intervention discontinuation, Up to approximately 5 years|Time to Deterioration (TTD) of lung cancer symptoms, TTD of lung cancer symptoms is defined as time from randomization to the first confirmed clinically meaningful deterioration as assessed by the Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC SAQ) total score. The NSCLC-SAQ is a 7-item instrument that assesses symptoms relevant to NSCLC. It contains five domains and accompanying items that are identified as symptoms of NSCLC: cough (1 item), pain (2), dyspnea (1), fatigue (2), and appetite (1). The (total) lowest score possible is 0, and the highest (total) score possible is 20. Higher scores indicate more severe symptoms., Up to approximately 5 years|TTD in physical functioning, TTD in physical functioning is defined as time from randomization to the first confirmed clinically meaningful deterioration as assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ C30). The EORTC QLQ C30 is a 30-item questionnaire. Participant responses will be scored in a range of 0-100. A higher value indicates a better level of physical function., Up to approximately 5 years|Number of participants with anti-drug antibodies (ADA) against Dostarlimab, Up to approximately 5 years|Number of participants with ADA against Belrestotug, Up to approximately 5 years