Non-small Cell Lung Cancer (NSCLC)
Conditions
Interventions
Drug: Pumitamig
Drug: Pembrolizumab
Sponsors
Erdmann Coronado Cinthya
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Participants must have a histologically or cytologically confirmed diagnosis of Non-Small Cell Lung Cancer (NSCLC) (squamous and nonsquamous) with Stage IIIB/IIIC or Stage IV disease. - Participants must have a programmed death ligand-1 (PD-L1) expression >= 50%. - Participants must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. - Participants must have no prior systemic anti-tumor therapy for locally advanced or metastatic NSCLC. - Participants must have an Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
Exclusion criteria
Exclusion criteria: - Participants must not have any documented actionable genomic alteration (AGA) for which first-line (1L) approved therapies are indicated. - Participants must not have any symptomatic untreated central nervous system (CNS) metastases, leptomeningeal metastases (carcinomatous meningitis) or spinal cord compression. - Participants must not have any significant cardiovascular impairment as evidenced by uncontrolled hypertension (despite optimal medical treatment), congestive heart failure, active coronary disease (within 6 months prior to randomization), ventricular arrhythmias, or major thrombotic or embolic events or major hemorrhagic events (within 6 months prior to randomization), or significant risk of pulmonary hemorrhage. - Participants must not an active autoimmune disease. - Other protocol-defined Inclusion/Exclusion criteria apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Progression-free survival (PFS) by blinded independent central review (BICR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 - Overall survival (OS) | — |
Secondary
| Measure | Time frame |
|---|---|
| - PFS by investigator according to RECIST v1.1 - OR by BICR according to RECIST v1.1 - DCR by BICR according to RECIST v1.1 - DOR by BICR according to RECIST v1.1 - TTR by BICR according to RECIST v1.1 - Time to definitive deterioration (TTDD) based on NSCLC-SAQ defined as the time from randomization until a definitive clinically meaningful worsening in symptoms or in NSCLC-SAQ total score | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Finland, France, Germany, Hungary, India, Italy, Japan, Malaysia, Mexico, Netherlands, Norway, Peru, Poland, Portugal, Romania, Singapore, South Korea, Spain, Sweden, United States
Contacts
Public ContactCinthya Erdmann
Bristol-Myers Squibb
Outcome results
None listed