Non-small-cell lung cancer
Conditions
Interventions
Dostarlimab
Belrestotug
Pembrolizumab
Placebo (normal saline)
Sponsors
Ishibashi Hideyasu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Has a histologically or cytologically confirmed diagnosis of 1 of the following: a. Locally advanced, unresectable NSCLC (not eligible for curative surgery and/or definitive radiotherapy with or without chemotherapy), or b. Metastatic NSCLC. 2.Has not received prior systemic therapy for their locally advanced or metastatic NSCLC. 3.Provides a tumor tissue sample obtained at the time of or after the initial diagnosis of locally advanced or metastatic NSCLC. 4.Has measurable disease (at least 1 target lesion) based on RECIST 1.1, as determined by the investigator. 5.Has a PD-L1-high (TC>-50%) tumor as determined by the assay at a central laboratory. 6.Has adequate organ function.
Exclusion criteria
Exclusion criteria: 1.Has NSCLC with a tumor that harbors any of the following molecular alterations: a.EGFR mutations that are sensitive to available targeted inhibitor therapy. b.ALK translocations that are sensitive to available targeted inhibitor therapy. c.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. 2.Has had major surgery within 4 weeks of the first dose of study intervention or has received lung radiation therapy of >30Gy within 6months of the first dose of study intervention. 3.Has received prior therapy with any immune checkpoint inhibitors, including antibodies or drugs targeting PD-(L)1, CTLA-4, TIGIT, or other checkpoint pathways. 4.Has never smoked, defined as smoking <100 tobacco cigarettes in a lifetime 5.Has an invasive malignancy or history of invasive malignancy other than the disease under study within the last 5 years. 6.Has known symptomatic, untreated, or actively progressing brain metastases and/or leptomeningeal disease. 7.Has autoimmune disease or syndrome (current or history thereof) that required systemic treatment within the past 2 years. 8.Has symptomatic ascites or pleural effusion or pericardial effusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Incidence of TEAEs and SAEs -Incidence of TEAEs/SAEs leading to dose withdrawals or treatment discontinuations | — |
Countries
Argentina, Belgium, Brazil, Canada, China, Czechia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Italy, Japan, Korea, Mexico, Netherlands, Panama, Philippines, Poland, Portugal, Serbia, Singapore, Spain, Sweden, Taiwan, Thailand, Turkey, United Kingdom, United States
Contacts
Public ContactHideyasu Ishibashi
GlaxoSmithKline K.K.
Outcome results
None listed