Repositioning Immunotherapy in Veterans With Lung Cancer
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
Study locations (7)
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, 06516-2770
VA Central Office, Washington, DC
Washington D.C., District of Columbia, 20420-0001
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Indianapolis, Indiana, 46202-2884
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, 48105-2303
Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
Omaha, Nebraska, 68105-1850
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, 77030-4211
Richmond VA Medical Center, Richmond, VA
Richmond, Virginia, 23249-0001