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Recruiting NCT06275360

Repositioning Immunotherapy in VetArans With Lung Cancer

Phase II Interventional Non-Small Cell Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nivolumab.
Who it may be relevant to
Registry conditions: Non-Small Cell Lung Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Repositioning Immunotherapy in Veterans With Lung Cancer

Overview

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]
  • Treatment Tolerance [Time frame: Approximately three years after enrollment]
Secondary outcome measures (3)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 7 centers
  • VA Connecticut Healthcare System West Haven Campus, West Haven, CT — West Haven
  • VA Central Office, Washington, DC — Washington D.C.
  • Richard L. Roudebush VA Medical Center, Indianapolis, IN — Indianapolis
  • VA Ann Arbor Healthcare System, Ann Arbor, MI — Ann Arbor
  • Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE — Omaha
  • Michael E. DeBakey VA Medical Center, Houston, TX — Houston
  • Richmond VA Medical Center, Richmond, VA — Richmond

Identifiers

NCT: NCT06275360 · SPLP-002-23F

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗