Lung Cancer EA5142

May 09, 2017

Sponsor: National Cancer Institute (NCI)

Number: EA5142

Eligible patients who enroll in the study will be randomly assigned (by chance) to this phase III trial that studies how well Nivolumab after surgery and chemotherapy work in treating patients with stage IB-IIIA (Click here for lung cancer staging definitions) non-small cell lung cancer. Phase III trials: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.  Monoclonal antibodies, such as Nivolumab, may stimulate the immune system in different ways and kill tumor cells remaining after surgery and standard of care chemotherapy.

Who’s eligible:

  • Patients must have undergone complete surgical resection (surgically cut out) of their stage IB (>= 4 cm), II or IIIA NSCLC (non-small cell lung cancer) according to the American Joint Committee on Cancer (AJCC) 7th edition and have had negative surgical margins. Baseline chest computed tomography (CT) must be performed within 1 month (30 days) of randomization to ensure no evidence of disease. If clinically indicated; additional imaging studies must be performed to rule out metastatic disease.
  • Patients must be registered to the ALCHEMIST-SCREEN (ALLIANCE A151216) trial prior to randomization. Non-squamous tumors must be epidermal growth factor receptor (EGFR) and anaplastic lymphoma receptor tyrosine kinase (ALK) wild-type (results ascertained in centrally as part of ALCHEMIST-SCREEN protocol).
  • This study is for patients age 18 and older.

Available at: The Hospital of Central Connecticut, Hartford Hospital, Backus Hospital- Eastern Connecticut Hematology and Oncology.

Cancer Clinical Research Office