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NCT06275360 | RECRUITING | Non-Small Cell Lung Cancer

Repositioning Immunotherapy in VetArans With Lung Cancer
Sponsor:

VA Office of Research and Development

Brief 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.

Condition or disease

Non-Small Cell Lung Cancer

Intervention/treatment

Nivolumab

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 25 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Repositioning Immunotherapy in Veterans With Lung Cancer
Actual Study Start Date : 2024-03-01
Estimated Primary Completion Date : 2027-02-28
Estimated Study Completion Date : 2030-03-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion 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).
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.
Repositioning Immunotherapy in VetArans With Lung Cancer

Location Details

NCT06275360

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

NOT YET RECRUITING

United States, California

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

West Los Angeles, California, United States, 90073-1003

RECRUITING

United States, Connecticut

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

West Haven, Connecticut, United States, 06516-2770

RECRUITING

United States, Road cancer

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Road cancer, United States, 48105-2303

NOT YET RECRUITING

United States, Nebraska

Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE

Omaha, Nebraska, United States, 68105-1850

NOT YET RECRUITING

United States, North Carolina

Durham VA Medical Center, Durham, NC

Durham, North Carolina, United States, 27705-3875

NOT YET RECRUITING

United States, Ohio

Louis Stokes VA Medical Center, Cleveland, OH

Cleveland, Ohio, United States, 44106-1702

NOT YET RECRUITING

United States, Virginia

Hunter Holmes McGuire VA Medical Center, Richmond, VA

Richmond, Virginia, United States, 23249-0001