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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
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)
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, United States
RECRUITINGVA Central Office, Washington, DC
Washington D.C., District of Columbia, United States
RECRUITINGProgression-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
Adverse Events
Frequency of adverse events assessed by Common Terminology Criteria for Adverse Events (CTCAE) criteria 5.0 classified by body system, grade, and attribution.
Time frame: Approximately two years after enrollment
Best overall response rate (BOR)
Defined as the proportion of participants who achieve a confirmed either a best response of complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria as assessed by central review.
Time frame: Approximately two years after enrollment
Overall survival
Defined as the time from start of treatment to the date of death from any cause..
Time frame: Approximately two years after enrollment
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Richard L. Roudebush VA Medical Center, Indianapolis, IN
Indianapolis, Indiana, United States
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, United States
RECRUITINGOmaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
Omaha, Nebraska, United States
RECRUITINGMichael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, United States
RECRUITINGRichmond VA Medical Center, Richmond, VA
Richmond, Virginia, United States
RECRUITING