Status:

RECRUITING

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)

Lead Sponsor:

Bristol-Myers Squibb

Collaborating Sponsors:

BioNTech SE

Conditions:

Non-small Cell Lung Cancer (NSCLC)

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief Summary

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.

Key Trial Info

Start Date :

March 16 2026

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2033

Estimated Enrollment :

850 Patients enrolled

Trial Details

Trial ID

NCT07361497

Start Date

March 16 2026

End Date

December 31 2033

Last Update

April 6 2026

Active Locations (255)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 64 (255 locations)

1

Southern Cancer Center Pc

Daphne, Alabama, United States, 36526

2

Local Institution - 0780

Chandler, Arizona, United States, 85224

3

Local Institution - 0585

Golden, Colorado, United States, 80401

4

Medical Oncology Hematology Consultants, PA

Newark, Delaware, United States, 19713

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) | DecenTrialz