Repositioning Immunotherapy in Veterans With Lung Cancer
Status: Recruiting
Location: See all (7) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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)
Locations
United States
Connecticut
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
RECRUITING
West Haven
Washington, D.c.
VA Central Office, Washington, DC
RECRUITING
Washington D.c.
Indiana
Richard L. Roudebush VA Medical Center, Indianapolis, IN
RECRUITING
Indianapolis
Michigan
VA Ann Arbor Healthcare System, Ann Arbor, MI
RECRUITING
Ann Arbor
Nebraska
Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
RECRUITING
Omaha
Texas
Michael E. DeBakey VA Medical Center, Houston, TX
RECRUITING
Houston
Virginia
Richmond VA Medical Center, Richmond, VA
RECRUITING
Richmond
Contact Information
Primary
Nithya Ramnath, MD
nithya.ramnath@va.gov
(734) 769-7100
Backup
Garth W Strohbehn, MD MSc
garth.strohbehn@va.gov
(734) 769-7100
Time Frame
Start Date: 2024-03-01
Estimated Completion Date: 2030-03-31
Participants
Target number of participants: 25
Treatments
Experimental: Chemoimmunotherapy followed by radiotherapy
Nivolumab (Opdivo) + plus platinum-doublet chemotherapy followed by radiotherapy
Related Therapeutic Areas
Sponsors
Leads: VA Office of Research and Development