Pumitamig versus durvalumab after chemoradiation for unresectable stage III NSCLC

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 trial enrolls people with unresectable stage III NSCLC who have completed at least two cycles of platinum-based concurrent chemoradiotherapy (including radiation ≥54 Gy) and who have no progressive disease after treatment. Participants will be assigned to receive either Pumitamig or durvalumab as consolidation therapy and will be followed for disease progression, survival, and side effects. Key exclusions include non-squamous tumors with documented EGFR or ALK alterations, active autoimmune disease, and significant cardiovascular impairment. The study directly compares efficacy and safety outcomes between the two drugs in this post-chemoradiation setting.

Why it matters

Who can join: the full rules

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.

Where it's running

• Southern Cancer Center Pc
  Daphne, Alabama, United States Recruiting
• Intermountain Health Cancer Center Lutheran Hospital
  Golden, Colorado, United States Recruiting
• Medical Oncology Hematology Consultants, PA
  Newark, Delaware, United States Recruiting
• Florida Clinical Trials Group
  Tamarac, Florida, United States Recruiting
• Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
  Marietta, Georgia, United States Recruiting
• University of Chicago Medical Center
  Chicago, Illinois, United States Recruiting

+209 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
• Email: Clinical.Trials@bms.com
• Phone: 855-907-3286

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.