Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
study ends around

Description

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%.

Official Title

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%.

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, Non-Small-Cell Lung Carcinoma

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 CAN'T join 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.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Locations

  • Local Institution - 0422 not yet accepting patients
    Los Angeles California 90095 United States
  • Local Institution - 0352 not yet accepting patients
    Beverly Hills California 90211 United States
  • Orange Coast Memorial Medical Center accepting new patients
    Fountain Valley California 92708 United States
  • Local Institution - 0403 not yet accepting patients
    Oakland California 94611 United States
  • Local Institution - 0407 not yet accepting patients
    Anaheim California 92801 United States
  • Local Institution - 0027 not yet accepting patients
    Los Alamitos California 90720 United States
  • Local Institution - 0208 not yet accepting patients
    Pleasant Hill California 94523 United States
  • Local Institution - 0416 not yet accepting patients
    Walnut Creek California 94598 United States
  • Texas Oncology - San Antonio accepting new patients
    San Antonio Texas 78217 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Bristol-Myers Squibb
Links
BMS Clinical Trial Information BMS Clinical Trial Patient Recruiting
ID
NCT07361510
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 750 study participants
Last Updated