Trial purpose
Cancer treatment
Tumor type
Lung cancer
Age
18+
Trial acronym
ROSETTA Lung-202
Clinical summary
Summary
The purpose of this study is to evaluate the efficacy of two immunotherapies, Pumitamig versus Pembrolizumab, in people with previously untreated advanced Non-Small Cell Lung Cancer (NSCLC) with PD-L1 ≥ 50%.
You may be eligible for this study if you have:
- NSCLC with Stage IIIB/IIIC or Stage IV disease.
- Programmed death ligand-1 (PD-L1) expression ≥ 50%.
- Not had prior systemic anti-cancer treatment for locally advanced or metastatic NSCLC. Treatment at an earlier stage of disease may be permitted.
Eligible participants will be randomly assigned (by chance) to receive either Pumitamig or Pembrolizumab.
Conditions
This trial is treating people with locally advanced or metastatic non-small cell lung cancer
Eligibility
Inclusion
- 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
- 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.
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
Exclusion
- You have certain types of non-cancer medical conditions.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov, EU Clinical Trials Register *. View further details about this trial on the registry via the links below:
- NCT07361510 *
- 2025-523586-18 *
- CA266-0002; U1111-1326-9286
Trial sponsor
Bristol-Myers Squibb
Scientific Title
A Randomized, Double-Blind, Phase 3 Study of Pumitamig Monotherapy Compared to Pembrolizumab as First-line Treatment in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With PD-L1 ≥ 50%.
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