NCT06275360 · VA Office of Research and Development
Repositioning Immunotherapy in VetArans With Lung Cancer
(RIVAL)
What this study is about
This study is a conducted at multiple hospitals Phase II single treatment group$1 trial to assess the safety and effectiveness of chemotherapy and immunotherapy followed by radiotherapy in patients with unresectable Stage III NSCLC.
View original scientific 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.
Interventions
DRUG
Nivolumab
Carboplatin, paclitaxel, and nivolumab for three cycles (for squamous cell lung cancer) or Carboplatin, pemetrexed, and nivolumab for three cycles (for lung adenocarcinoma) Followed by radiotherapy (60 Gy in 30 fractions) Followed by adjuvant nivolumab (six cycles)
Primary outcome measures
Progression-free survival
Time frame: Approximately two years after enrollment
Defined as the time from start of treatment to radiographic/clinical progression (per irRECIST1.1), or death from any cause, whichever occurs first.
Treatment Tolerance
Time frame: Approximately three years after enrollment
Proportion of patients able to complete prescribed treatment course (all planned cycles of systemic therapy and all fractions of radiotherapy).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 determ
Where
- West Haven, Connecticut
- Washington D.C., District of Columbia
- Indianapolis, Indiana
- Ann Arbor, Michigan
- Omaha, Nebraska
- Houston, Texas
- Richmond, Virginia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 2, 2026 · Source of record for eligibility and locations