Non-small cell lung cancer
Conditions
Interventions
Drug: Dostarlimab
Dostarlimab will be administered as an IV infusion.
Drug: Belrestotug
Belrestotug will be administered as an IV infusion.
Drug: GSK6097608
GSK6097608 will be administered as an IV
Sponsors
Ishibashi Hideyasu
Eligibility
Sex/Gender
All
Inclusion criteria
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 recent 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
Exclusion criteria: -Presence of Epidermal growth factor receptor (EGFR) mutations, Anaplastic lymphoma kinase (ALK) translocations, or other known genomic aberrations or oncogenic driver mutations for which a locally approved therapy is available. All participants with non squamous histology must have been tested for EGFR mutation and ALK translocation status -Had major surgery within 4 weeks or lung radiation of >30 grays (Gy) therapy within 6 months prior to the first dose of study intervention -Received prior therapy with any immune checkpoint inhibitors -Never smoker, 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 and/or leptomeningeal disease (regardless of symptomatology, treatment status, or stability) -Autoimmune disease or syndrome that required systemic treatment within the past 2 years -Receiving 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 <- 6 months prior to enrollment -Current unstable liver or biliary disease -Severe infection within 4 weeks prior to randomization -Positive for tuberculosis, human immunodeficiency virus (HIV) infection, hepatitis B, 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR, defined as the percentage of participants with complete response (CR) or partial response (PR) per RECIST 1.1 by investigator assessment. | — |
Secondary
| Measure | Time frame |
|---|---|
| -ORR for comparison between experimental arms -Progression free survival (PFS) -Overall survival (OS) -Duration of response (DOR) -Number of participants with Treatment Emergent adverse events (TEAEs) and Adverse events of Special Interest (AESIs) -Number of participants with Serious adverse events (SAEs) -Number of participants with TEAEs or SAEs leading to dose modifications (including dose delay and study intervention discontinuation) -Number of participants with positive antidrug antibodies (ADA) against belrestotug -Number of participants with positive antidrug antibodies (ADA) against dostarlimab -Number of participants with positive antidrug antibodies (ADA) against GSK6097608 -Maximum Observed Serum Concentration (Cmax) for belrestotug -Maximum Observed Serum Concentration (Cmax) for dostarlimab -Maximum Observed Serum Concentration (Cmax) for GSK6097608 -Minimum Observed Serum Concentration (Cmin) for belrestotug -Minimum Observed Serum Concentration (Cmin) for dostarlimab -Minimum Observed Serum Concentration (Cmin) for GSK6097608 | — |
Countries
Argentina, Belgium, Brazil, Finland, France, Germany, Greece, Hungary, Italy, Japan, Korea, Mexico, Netherlands, Poland, Portugal, South Africa, Spain, Thailand, Turkey, United Arab Emirates, United Kingdom, United States
Contacts
Public ContactHideyasu Ishibashi
GlaxoSmithKline K.K.
Outcome results
None listed