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RecruitingInterventionalPhase 2

Repositioning Immunotherapy in Veterans With Lung Cancer

NCT ID: NCT06275360Sponsor: VA Office of Research and DevelopmentLast updated: 2026-03-02

Summary

This study is a multicenter Phase II single arm trial to assess the safety and efficacy of chemotherapy and immunotherapy followed by radiotherapy in patients with unresectable Stage III NSCLC.

Arms & interventions

  • DrugNivolumab

    Carboplatin, paclitaxel, and nivolumab for three cycles (for squamous cell lung cancer) or Carboplatin, pemetrexed, and nivolumab for three cycles (for lung adenocarcinoma) Followed by radiotherapy (60 Gy in 30 fractions) Followed by adjuvant nivolumab (six cycles)

Outcome measures

Primary

  • Progression-free survival

    Defined as the time from start of treatment to radiographic/clinical progression (per irRECIST1.1), or death from any cause, whichever occurs first.

    Time frame: Approximately two years after enrollment

  • Treatment Tolerance

    Proportion of patients able to complete prescribed treatment course (all planned cycles of systemic therapy and all fractions of radiotherapy).

    Time frame: Approximately three years after enrollment

Secondary

  • Adverse Events

    Time frame: Approximately two years after enrollment

  • Best overall response rate (BOR)

    Time frame: Approximately two years after enrollment

  • Overall survival

    Time frame: Approximately two years after enrollment

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
Inclusion Criteria: * Patient must have a performance status of 0-1 (ECOG Performance Scale) * Patient must be a candidate for concurrent chemoradiation * Unresectable Stage III NSCLC as assessed by investigator or multidisciplinary tumor board assessment * PD-L1 tumor expression greater than or equal to 1% * Presence of measurable disease according to RECIST v1.1 * Adequate organ function * Available tissue (archival FFPE preferred) with adequate tumor content ( 20% tumor cellularity) Exclusion Criteria: * Active autoimmune disease that has requires immunosuppressive therapy in the previous year * Uncontrolled primary or acquired immunodeficiency (including HIV) * Baseline corticosteroid usage (\>10 mg prednisone or equivalent daily) aside from supportive medication use * Tumor with known EGFR, ALK, ROS1, MET or RET mutations/fusions * Presence of significant comorbidities precluding participation in a clinical study as determined by investigator * Prior thoracic radiotherapy or prior systemic treatment for stage IIIB/IV NSCLC * Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial * Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with informed consent through 180 days after the last dose of trial treatment * Has a known history of active TB (Bacillus Tuberculosis) * Has known active Hepatitis B or Hepatitis C * Has received a live vaccine within 30 days of enrollment * Known diagnosis of Interstitial Lung Disease * Inability to provide informed consent

Study locations (7)

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

West Haven, Connecticut, 06516-2770

Recruiting
Michal Rose, MD · Contact
Alicia Roy · Contact

VA Central Office, Washington, DC

Washington D.C., District of Columbia, 20420-0001

Recruiting
Irina Veytsman, MD · Contact
Ramesh Subrahmanyam · Contact

Richard L. Roudebush VA Medical Center, Indianapolis, IN

Indianapolis, Indiana, 46202-2884

Recruiting
Shadia Jalal, MD · Contact
Aleksandra Radovanovich · Contact

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, 48105-2303

Recruiting
Brittany M Pannecouk, BS · Contact
Laura A Randolph, BA · Contact
Michael D Green · Sub Investigator
Nithya Ramnath, MD · Principal Investigator

Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE

Omaha, Nebraska, 68105-1850

Recruiting
Apar Kishor P Ganti, MD · Contact
Anna Kellogg · Contact

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030-4211

Recruiting
Daniel Shin, MD · Contact
Michael Sustaita · Contact

Richmond VA Medical Center, Richmond, VA

Richmond, Virginia, 23249-0001

Recruiting
Bhaumik Patel, MD · Contact