Repositioning Immunotherapy in Veterans With Lung Cancer
VA Office of Research and Development
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy 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 previou…
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)
Locations (7)
- VA Connecticut Healthcare System West Haven Campus, West Haven, CTWest Haven, Connecticut
- VA Central Office, Washington, DCWashington D.C., District of Columbia
- Richard L. Roudebush VA Medical Center, Indianapolis, INIndianapolis, Indiana
- VA Ann Arbor Healthcare System, Ann Arbor, MIAnn Arbor, Michigan
- Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NEOmaha, Nebraska
- Michael E. DeBakey VA Medical Center, Houston, TXHouston, Texas