NCT06275360PHASE2Recruiting
Repositioning Immunotherapy in VetArans With Lung Cancer
VA Office of Research and Development
Start Date
3/1/2024
Completion Date
3/31/2030
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 Criteria
Age Range: 18 years to No maximum
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
Interventions
DRUG
Nivolumab
Conditions
Non-Small Cell Lung Cancer
Locations
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut 06516-2770
United States
VA Central Office, Washington, DC
Washington D.C., District of Columbia 20420-0001
United States
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Indianapolis, Indiana 46202-2884
United States
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan 48105-2303
United States
Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
Omaha, Nebraska 68105-1850
United States
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas 77030-4211
United States
Richmond VA Medical Center, Richmond, VA
Richmond, Virginia 23249-0001
United States