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Repositioning Immunotherapy in Veterans With Lung Cancer

This study is testing a treatment plan for unresectable Stage III non-small cell lung cancer (NSCLC), a type of lung cancer that cannot be removed by surgery. The plan involves chemotherapy (carboplatin and paclitaxel or pemetrexed) and nivolumab (an immunotherapy drug) for three cycles, followed by radiation therapy, and then more nivolumab for six cycles. You might be able to join if you have unresectable Stage III NSCLC, a good performance status (meaning you can do most daily activities), and your tumor shows at least 1% PD-L1 expression (a biomarker that helps predict response to immunotherapy). The study aims to see how long people live without their cancer growing (progression-free survival) and how well they tolerate the treatment. The current recruitment status is unclear.

Study design
This is a Phase II study involving 25 participants. It is a single-arm trial, meaning everyone receives the same treatment.
What's involved
You would receive three cycles of chemotherapy and nivolumab, followed by radiation therapy, and then six cycles of nivolumab. The study will assess your progression-free survival for approximately two years and treatment tolerance for approximately three years.
Compensation
Not stated in the trial record.
Follow-up
Progression-free survival will be measured at approximately two years after enrollment, and treatment tolerance will be measured at approximately three years after enrollment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06275360

Repositioning Immunotherapy in VetArans With Lung Cancer

Recruiting
PHASE2Ages 18+InterventionalTreatment
VA Office of Research and Development
~25 participants
Updated 2026-03-02 on ClinicalTrials.gov
What's tested:Nivolumab

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-free survival
Measured over Approximately two years after enrollment
+1 more outcome measured

Conditions

Non-Small Cell Lung Cancer

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Where it's being run

7 sites across 7 states
Connecticut1
District of Columbia1
Indiana1
Michigan1
Nebraska1
Texas1
Virginia1

Study leadership

  • Nithya Ramnath, MD · PRINCIPAL_INVESTIGATOR · VA Ann Arbor Healthcare System, Ann Arbor, MI

Who to contact

Nithya Ramnath, MD
[email protected]
(734) 769-7100
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Progression-free survivalApproximately 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 ToleranceApproximately three years after enrollment

    Proportion of patients able to complete prescribed treatment course (all planned cycles of systemic therapy and all fractions of radiotherapy).