BrUOG 397: NEO Rad (LOW): Neoadjuvant Low Dose Stereotactic Body Radiotherapy, Ipilimumab and Nivolumab

This single-arm phase 2 study will enroll patients with resectable and operable stage IB - III non-small cell lung cancer and treat them with pre-operative ipilimumab + nivolumab plus low-dose stereotactic body radiation therapy (SBRT) delivered concurrently. Only patients who proceed to surgery will be evaluable for the primary endpoint. The primary efficacy outcome measurement will be pathologic response (including Major Pathologic Response (MPR), and Complete Pathologic Response (CPR)). Secondary outcome measures include safety, and exploratory biomarkers of immune response in pre- and post

Trial Details

NCT ID
NCT04933903
Phase
PHASE2
Sponsor
Brown University
Status
RECRUITING
Cancer Type
Lung Cancer
Interventions
  • Ipilimumab
  • Nivolumab
  • SBRT
Locations (sample)
  • Providence, Rhode Island, United States|41.82399,-71.41283

Key Eligibility Criteria

  • Pathologically confirmed NSCLC
  • ECOG Performance Status 0-1.
  • Pulmonary function capacity capable of tolerating the proposed lung resection. FEV1 at least 2 L. If less than 2 L, the predicted postoperative for…
  • Resectable stage IB-IIIB (T2-3N0, T1-T3N1-2) NSCLC (per the 8th Edition American Joint Committee on Cancer (AJCC) classification) who are candidate…

For full eligibility, visit ClinicalTrials.gov.

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