Non-Small Cell Lung CancerPhase 2RIVALNCT06275360
Repositioning Immunotherapy in VetArans With Lung Cancer
A Phase 2 study testing Nivolumab in people with Non-Small Cell Lung Cancer, run by VA Office of Research and Development at 7 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Nivolumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 7 sitesUnited States
- Study dates
- 1 Mar 2024to 31 Mar 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, 48105-2303
Brittany M Pannecouk, BS, (734) 845-3966, brittany.pannecouk@va.gov
Laura A Randolph, BA, (734) 845-5091, Laura.Randolph@va.gov
- Recruiting
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, 77030-4211
Daniel Shin, MD, (71-3) -7939, Daniel.Shin@va.gov
Michael Sustaita, (713) 7947939, Michael.Sustaita@va.gov
- Recruiting
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Indianapolis, Indiana, 46202-2884
Shadia Jalal, MD, 317-903-1978, SHADIA.JALAL@va.gov
Aleksandra Radovanovich, 3177199841, Aleksandra.Radovanovich@va.gov
- Recruiting
Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
Omaha, Nebraska, 68105-1850
Apar Kishor P Ganti, MD, 402-346-8800 ext. 3846, Aparkishor.Ganti@va.gov
Anna Kellogg, 4029954143, Anna.Kellogg@va.gov
- Recruiting
Richmond VA Medical Center, Richmond, VA
Richmond, Virginia, 23249-0001
Bhaumik Patel, MD, 804-675-5446, Bhaumik.Patel@va.gov
- Recruiting
VA Central Office, Washington, DC
Washington D.C., District of Columbia, 20420-0001
Irina Veytsman, MD, 202-745-8000, Irina.Veytsman@va.gov
Ramesh Subrahmanyam, 2027458000 ext. 57292, Ramesh.Subrahmanyam@va.gov
- Recruiting
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, 06516-2770
Michal Rose, MD, 203-932-5711 ext. 2832, Michal.Rose@va.gov
Alicia Roy, 2039325711 ext. 3006, Alicia.Roy@va.gov
About this study
Official title: 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.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Nivolumab
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabDrug
Also called Opdivo
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)
| Study group | Role | What they receive |
|---|---|---|
| Chemoimmunotherapy followed by radiotherapy | Experimental | Nivolumab (Opdivo) + plus platinum-doublet chemotherapy followed by radiotherapy Receives: Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Defined as the time from start of treatment to radiographic/clinical progression (per irRECIST1.1), or death from any cause, whichever occurs first.
Measured: Approximately two years after enrollment
Treatment Tolerance
Proportion of patients able to complete prescribed treatment course (all planned cycles of systemic therapy and all fractions of radiotherapy).
Measured: Approximately three years after enrollment
Secondary outcomes (3)
Adverse Events
Frequency of adverse events assessed by Common Terminology Criteria for Adverse Events (CTCAE) criteria 5.0 classified by body system, grade, and attribution.
Measured: Approximately two years after enrollment
Best overall response rate (BOR)
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.
Measured: Approximately two years after enrollment
Overall survival
Defined as the time from start of treatment to the date of death from any cause..
Measured: Approximately two years after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start1 Mar 2024
- Primary completion28 Feb 2027 (estimated)
- Study completion31 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Carboplatin, paclitaxel, and nivolumab for three cycles followed by radiotherapy followed by nivolumab (for squamous cell lung cancer) OR Carboplatin, pemetrexed, and nivolumab for three cycles followed by radiotherapy followed by nivolumab (for lung adenocarcinoma)
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Nithya Ramnath, MD, Principal investigator, VA Ann Arbor Healthcare System, Ann Arbor, MI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06275360
- Sponsor's protocol ID
- SPLP-002-23F
- Acronym
- RIVAL
- Status last verified
- Feb 2026
- First submitted
- 30 Jan 2024
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repositioning Immunotherapy in Veterans With Lung Cancer
- ClinicalTrials.gov ID
- NCT06275360
- Acronym / sponsor ID
- RIVAL / SPLP-002-23F
- Conditions
- Non-Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 31 Mar 2030 (estimated)
- First posted
- 23 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Carboplatin, paclitaxel, and nivolumab for three cycles followed by radiotherapy followed by nivolumab (for squamous cell lung cancer) OR Carboplatin, pemetrexed, and nivolumab for three cycles followed by radiotherapy followed by nivolumab (for lung adenocarcinoma)
| Arm | Type | Receives |
|---|---|---|
| Chemoimmunotherapy followed by radiotherapy | Experimental | Drug: NivolumabNivolumab (Opdivo) + plus platinum-doublet chemotherapy followed by radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NivolumabAlso: OpdivoCarboplatin, 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) | Drug | Chemoimmunotherapy followed by radiotherapy |
Primary outcome
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).
3 secondary outcomes
Adverse Events
Time frame: Approximately two years after enrollment
Best overall response rate (BOR)
Time frame: Approximately two years after enrollment
Overall survival
Time frame: Approximately two years after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nithya Ramnath, MD principal investigator
VA Ann Arbor Healthcare System, Ann Arbor, MI
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nivolumab in people with Non-Small Cell Lung Cancer, run by VA Office of Research and Development at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nithya Ramnath, MD ((734) 769-7100, nithya.ramnath@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: Approximately two years after enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.