Repositioning Immunotherapy in VetArans With Lung Cancer (RIVAL)

February 26, 2026 updated by: VA Office of Research and Development

Repositioning Immunotherapy in Veterans With Lung Cancer

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Connecticut
      • West Haven, Connecticut, United States, 06516-2770
        • Recruiting
        • VA Connecticut Healthcare System West Haven Campus, West Haven, CT
        • Contact:
        • Contact:
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20420-0001
    • Indiana
      • Indianapolis, Indiana, United States, 46202-2884
        • Recruiting
        • Richard L. Roudebush VA Medical Center, Indianapolis, IN
        • Contact:
        • Contact:
    • Michigan
      • Ann Arbor, Michigan, United States, 48105-2303
        • Recruiting
        • VA Ann Arbor Healthcare System, Ann Arbor, MI
        • Principal Investigator:
          • Nithya Ramnath, MD
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Michael D Green
    • Nebraska
      • Omaha, Nebraska, United States, 68105-1850
        • Recruiting
        • Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
        • Contact:
        • Contact:
    • Texas
      • Houston, Texas, United States, 77030-4211
        • Recruiting
        • Michael E. DeBakey VA Medical Center, Houston, TX
        • Contact:
        • Contact:
    • Virginia
      • Richmond, Virginia, United States, 23249-0001
        • Recruiting
        • Richmond VA Medical Center, Richmond, VA
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chemoimmunotherapy followed by radiotherapy
Nivolumab (Opdivo) + plus platinum-doublet chemotherapy followed by radiotherapy
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)
Other Names:
  • Opdivo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Approximately two years after enrollment
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).
Approximately three years after enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: Approximately two years after enrollment
Frequency of adverse events assessed by Common Terminology Criteria for Adverse Events (CTCAE) criteria 5.0 classified by body system, grade, and attribution.
Approximately two years after enrollment
Best overall response rate (BOR)
Time Frame: Approximately two years after enrollment
Defined as the proportion of participants who achieve a confirmed either a best response of complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria as assessed by central review.
Approximately two years after enrollment
Overall survival
Time Frame: Approximately two years after enrollment
Defined as the time from start of treatment to the date of death from any cause..
Approximately two years after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: Nithya Ramnath, MD, VA Ann Arbor Healthcare System, Ann Arbor, MI

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2024

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

March 31, 2030

Study Registration Dates

First Submitted

January 30, 2024

First Submitted That Met QC Criteria

February 16, 2024

First Posted (Actual)

February 23, 2024

Study Record Updates

Last Update Posted (Actual)

March 2, 2026

Last Update Submitted That Met QC Criteria

February 26, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPLP-002-23F

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe