Lung Cancer - S1800D (Lung-MAP Non-Match Sub-Study)

Phase II/III Study of N-803 (ALT-803) plus Pembrolizumab versus Standard of Care in Participants with Stage IV or Recurrent Non-Small Cell Lung Cancer Previously Treated with Anti-PD-1 or Anti-PD-L1 Therapy

This phase II/III Lung-MAP trial studies how well immunotherapy treatment with N-803 (ALT-803) and pembrolizumab working in treating patients with non-small cell lung cancer that has spread to other places in the body (advanced). Natural killer cells, part of our immune system, are always on alert and ready to defend our bodies from many kinds of infection or rogue cells, such as those that cause cancer. N-803 (ALT-803) may activate natural killer cells so that they can stimulate an immune response to help fight cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving N-803 (ALT-803) and pembrolizumab may help shrink and stabilize lung cancer or prevent it from returning.

Eligibility Criteria

• Participant must have been assigned to S1800D by the SWOG Statistics and Data Management Center (SDMC) via the LUNGMAP or S1400 protocol.
• Participants with a known sensitizing mutation for which an FDA-approved targeted therapy for NSCLC exists, must have previously received at least one of the approved therapy(s).
• Participants must have received exactly one line of anti-PD-1 or anti-PD-L1 therapy for advanced disease; given lone or in combination with platinum-based chemotherapy.
• Participants must not have received any anti-CTLA4 therapy or other immune-modulatory therapy (e.g., anti-TIM-3; anti-LAG-3; anti-GITR, IL-2, IL-15)

This study is for patients age 18 Years and older.

Available at: Hartford Hospital, Manchester, Avon, Midstate Medical Center and Hospital of Central Connecticut