Repositioning Immunotherapy in VetArans With Lung Cancer

Description

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.

Conditions

Non-Small Cell Lung Cancer

Study Overview

Study Details

Study overview

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.

Repositioning Immunotherapy in Veterans With Lung Cancer

Repositioning Immunotherapy in VetArans With Lung Cancer

Condition
Non-Small Cell Lung Cancer
Intervention / Treatment

-

Contacts and Locations

West Los Angeles

VA Greater Los Angeles Healthcare System, West Los Angeles, CA, West Los Angeles, California, United States, 90073-1003

West Haven

VA Connecticut Healthcare System West Haven Campus, West Haven, CT, West Haven, Connecticut, United States, 06516-2770

Ann Arbor

VA Ann Arbor Healthcare System, Ann Arbor, MI, Ann Arbor, Michigan, United States, 48105-2303

Omaha

Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE, Omaha, Nebraska, United States, 68105-1850

Durham

Durham VA Medical Center, Durham, NC, Durham, North Carolina, United States, 27705-3875

Cleveland

Louis Stokes VA Medical Center, Cleveland, OH, Cleveland, Ohio, United States, 44106-1702

Richmond

Hunter Holmes McGuire VA Medical Center, Richmond, VA, Richmond, Virginia, United States, 23249-0001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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).
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

VA Office of Research and Development,

Michael D Green, PRINCIPAL_INVESTIGATOR, VA Ann Arbor Healthcare System, Ann Arbor, MI

Nithya Ramnath, MD, PRINCIPAL_INVESTIGATOR, VA Ann Arbor Healthcare System, Ann Arbor, MI

Study Record Dates

2030-03-31