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:

• Participants must be more than 18 years of age.

• 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
California
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
NOT_YET_RECRUITING
West Los Angeles
Connecticut
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
RECRUITING
West Haven
Michigan
VA Ann Arbor Healthcare System, Ann Arbor, MI
RECRUITING
Ann Arbor
North Carolina
Durham VA Medical Center, Durham, NC
NOT_YET_RECRUITING
Durham
Nebraska
Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
NOT_YET_RECRUITING
Omaha
Ohio
Louis Stokes VA Medical Center, Cleveland, OH
NOT_YET_RECRUITING
Cleveland
Virginia
Hunter Holmes McGuire VA Medical Center, Richmond, VA
NOT_YET_RECRUITING
Richmond
Contact Information
Primary
Nithya Ramnath, MD
nithya.ramnath@va.gov
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
Sponsors
Leads: VA Office of Research and Development

This content was sourced from clinicaltrials.gov