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RecruitingPhase 3

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)

ROSETTA Lung-202: 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%.

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares pumitamig with pembrolizumab to see how well they work for advanced non-small cell lung cancer. It is for people who have not had whole-body treatment for their advanced cancer and whose cancer has a PD-L1 protein level of 50% or higher.

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%.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have stage IIIB, IIIC, or IV non-small cell lung cancer, confirmed by a tissue or cell test.
  • Have a PD-L1 protein level of 50% or higher.
  • Have cancer that can be measured using the study’s rules.
  • Have had no whole-body cancer treatment for lung cancer that has spread nearby or to other parts of the body.
  • Be fully active or able to do light work despite limits on heavy physical activity.

Who can't join

  • Have a known cancer gene change with an approved drug recommended as the first treatment.
  • Have untreated cancer spread to the brain or spinal cord that causes symptoms.
  • Have cancer in the lining around the brain or spinal cord, or pressure on the spinal cord.
  • Have serious heart or blood vessel problems, such as blood pressure that stays high despite treatment, heart failure, or abnormal rhythms in the heart’s lower chambers.
  • Have had active heart artery disease, a major blood clot, or major bleeding within 6 months before being assigned a study treatment.
  • Have a high risk of bleeding in the lungs.
  • Have an active autoimmune disease, where the body’s defense system attacks healthy tissue.
  • Other study rules may also affect whether you can join.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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 * 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.

Study sites (41)

AL

AZ

CA

CO

FL

GA

IL

IN

MO

NC

NY

OH

OK

PA

TX

VA

WA

WI

WV

  • Charleston Area Medical Center (CAMC) · Charleston, WV 25304Ahmed Khalid, Site 0339 · Study contactMore trials in Charleston