Using immunotherapy for veterans with lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.