A Study to Evaluate Pumitamig Versus Durvalumab Following Concurrent Chemoradiation Therapy in Participants With Unresectable Stage III Non-small Cell Lung Cancer (NSCLC) (ROSETTA Lung-201)

Sponsor: Bristol-Myers Squibb

Sponsor score: 60

ClinicalTrials ID:NCT07361497

This clinical trial compares Pumitamig and Durvalumab in patients with unresectable stage III NSCLC post-chemoradiation. Participants receive specified doses of either drug on designated days. Eligibility includes adults with confirmed stage III NSCLC who have completed concurrent chemoradiation therapy. The study aims to assess the efficacy and safety of these treatments.

Patient Parameters

Program Overview

A study to evaluate Pumitamig versus Durvalumab following concurrent chemoradiation therapy in participants with unresectable stage III Non-small Cell Lung Cancer (NSCLC)

Eligibility Criteria

Inclusion Criteria

  • Participants must have a histologically- or cytologically-confirmed diagnoses of non-small cell lung cancer (NSCLC) with unresectable Stage III disease.
  • Participants must have received at least 2 cycles of platinum-based concurrent chemoradiotherapy (a total dose of radiation of at least 54 Gy).
  • Participants must have no progressive disease (PD) following treatment with concurrent chemoradiotherapy (CCRT).
  • Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1.

Exclusion Criteria

  • Participants with non-squamous histology must not have documented Epidermal Growth Factor Receptor (EGFR) and anaplastic lymphoma kinase (ALK) rearrangements.
  • Participants must not have an active autoimmune disease.
  • Participants must not have significant cardiovascular impairment such as uncontrolled hypertension (despite optimal medical treatment), congestive heart failure, active coronary disease (within 6 months prior to randomization), ventricular arrhythmias, major thrombotic or embolic events or major hemorrhagic events within 6 months prior to randomization, or significant risk of pulmonary hemorrhage.
  • Participants must not have advanced/clinically significant lung disease (within 6 months prior to randomization) or history of interstitial lung disease (ILD) or pneumonitis requiring treatment with systemic steroids (≥ Grade 2), or current or suspected ILD or pneumonitis.
  • Participants must not have any prior anticancer therapy (outside of CCRT) for locally advanced Stage III disease.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Locations

FACILITYZIPCITYSTATE
Southern Cancer Center Pc36526DaphneAlabama
Local Institution - 078085224ChandlerArizona
Local Institution - 058580401GoldenColorado
Medical Oncology Hematology Consultants, PA19713NewarkDelaware
Local Institution - 071134474OcalaFlorida
Local Institution - 075630060MariettaGeorgia
Local Institution - 039860637ChicagoIllinois
Local Institution - 085060201EvanstonIllinois
Illinois Cancer Care61615PeoriaIllinois
Fort Wayne Medical Oncology and Hematology46804Fort WayneIndiana

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