Actively Recruiting
Repositioning Immunotherapy in Veterans With Lung Cancer
Led by VA Office of Research and Development · Updated on 2026-03-02
25
Participants Needed
7
Research Sites
161 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a treatment approach combining chemotherapy, immunotherapy, and radiotherapy for patients with unresectable Stage III non-small cell lung cancer NSCLC. This Phase II multicenter trial aims to assess the safety and effectiveness of this combined treatment in veterans with lung cancer, focusing on progression-free survival and treatment tolerance over several years. Participants receive chemotherapy with platinum-doublet drugs along with the immunotherapy drug nivolumab for three cycles. This is followed by radiotherapy delivered as 60 Gy in 30 fractions. After radiotherapy, patients receive six cycles of adjuvant nivolumab. The study examines this treatment sequence as a single arm without a comparison group. During the trial, participants will be monitored for disease progression, response to treatment, overall survival, and adverse events for approximately two to three years after enrollment. Researchers will evaluate tumor measurements, organ function, and patient performance status, along with safety and tolerability of the treatment. The total participation time includes treatment and follow-up assessments to gather comprehensive data on outcomes and side effects.
CONDITIONS
Brief Title
Repositioning Immunotherapy in VetArans With Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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)
You will not qualify if you...
- 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
Research Team
N
Nithya Ramnath, MD
G
Garth W Strohbehn, MD MSc
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