Clareo Health | A Study to Evaluate the Efficacy of Pumitamig Versus Pembrolizumab in Participants With Previously Untreated Advanced Non-Small Cell Lung Cancer and PD-L1 ≥ 50%. (ROSETTA Lung-202)
A Study to Evaluate the Efficacy of Pumitamig Versus Pembrolizumab in Participants With Previously Untreated Advanced Non-Small Cell Lung Cancer and PD-L1 ≥ 50%. (ROSETTA Lung-202)
First line of the email MUST contain NCT # and Site #.
CONTACT
Lead
Bristol-Myers Squibb
With
BioNTech SE
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
