Non-Small Cell Lung Cancer (NSCLC)
Conditions
Keywords
Non-Small Cell Lung Cancer (NSCLC), 1L NSCLC, Programmed death ligand-1 (PD-L1), Frst line NSCLC, Advanced NSCLC, Metastatic NSCLC, Pumitamig, Pembrolizumab, ROSETTA LUNG-202, ROSETTA LUNG, CA2660002
Brief summary
The purpose of this study is to evaluate the efficacy of Pumitamig versus Pembrolizumab in participants with previously untreated advanced Non-Small Cell Lung Cancer and PD-L1 ≥ 50%.
Interventions
DRUGPumitamig
Specified dose on specified days
DRUGPembrolizumab
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
BioNTech SE
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
* 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/
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 | Up to approximately 3 years |
| Overall survival (OS) | Up to approximately 5 years |
Secondary
| Measure | Time frame |
|---|---|
| PFS by investigator according to RECIST v1.1 | Up to approximately 3 years |
| Objective Response (OR) by BICR according to RECIST v1.1 | Up to approximately 3 years |
| Duration of response (DOR) by BICR according to RECIST v1.1 | Up to approximately 3 years |
| Disease control rate (DCR) by BICR according to RECIST v1.1 | Up to approximately 3 years |
| Time to Response (TTR) by BICR according to RECIST v1.1 | Up to approximately 3 years |
| Time to definitive deterioration (TTDD) based on the Non-Small Cell Lung Cancer-Symptom Assessment Questionnaire (NSCLC-SAQ) defined as the time from randomization until a definitive clinically meaningful worsening in symptoms or in NSCLC-SAQ total score | Up to approximately 3 years |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czechia, Finland, France, Germany, Hungary, India, Italy, Japan, Malaysia, Mexico, Netherlands, Norway, Peru, Poland, Portugal, Romania, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, United States
Contacts
CONTACTBMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACTFirst line of the email MUST contain NCT # and Site #.
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed