Using immunotherapy for veterans with lung cancer
Repositioning Immunotherapy in Veterans With Lung Cancer
This study is testing if a combination of chemotherapy and immunotherapy can help veterans with advanced lung cancer feel better and live longer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Drugs / interventions | prednisone, chemotherapy, immunotherapy |
| Locations | 7 sites (West Haven, Connecticut and 6 other locations) |
| Trial ID | NCT06275360 on ClinicalTrials.gov |
What this trial studies
This Phase II multicenter trial evaluates the safety and efficacy of combining chemotherapy and immunotherapy, followed by radiotherapy, in veterans diagnosed with unresectable Stage III non-small cell lung cancer (NSCLC). Participants will receive nivolumab, an immunotherapy drug, and will be monitored for treatment outcomes. The study aims to determine if this approach can improve patient responses and overall survival rates in this challenging cancer stage.
Who should consider this trial
Good fit: Ideal candidates are veterans over 18 years old with unresectable Stage III NSCLC and specific tumor characteristics.
Not a fit: Patients with active autoimmune diseases requiring immunosuppressive therapy or those with certain genetic mutations may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for veterans suffering from advanced lung cancer.
How similar studies have performed: Other studies have shown promise in using immunotherapy for lung cancer, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
West Haven, Connecticut and 6 other locations
- VA Connecticut Healthcare System West Haven Campus, West Haven, CT — West Haven, Connecticut, United States (Recruiting)
- VA Central Office, Washington, DC — Washington D.C., District of Columbia, United States (Recruiting)
- Richard L. Roudebush VA Medical Center, Indianapolis, IN — Indianapolis, Indiana, United States (Recruiting)
- VA Ann Arbor Healthcare System, Ann Arbor, MI — Ann Arbor, Michigan, United States (Recruiting)
- Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE — Omaha, Nebraska, United States (Recruiting)
- Michael E. DeBakey VA Medical Center, Houston, TX — Houston, Texas, United States (Recruiting)
- Richmond VA Medical Center, Richmond, VA — Richmond, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Nithya Ramnath, MD — VA Ann Arbor Healthcare System, Ann Arbor, MI
- Study coordinator: Nithya Ramnath, MD
- Email: nithya.ramnath@va.gov
- Phone: (734) 769-7100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.