Harnessing Allo-immunity to Enhance Immune Checkpoint Inhibitor Responses in Advanced NSCLC

• Status: Not yet recruiting
• Trial end date: 2028-04-04
• Target enrollment: 0
• Participant gender: All

Summary

Veterans with advanced lung cancer may benefit from recent advances in technologies that is designed to change the activities of their own white blood cells and help kill tumors. However, many cancers can hide from white blood cells making white blood cells less effective in killing tumors. In this study the investigators plan to boost the activity of patients white blood cell by making tumor cells more visible to the white blood cells. This will be done by injecting antibodies and a new drug that together can make white blood cells inside tumors more active. The investigators plan to recruit sixteen people with advanced lung cancer to make sure that this treatment, which has not been done in any humans, is safe and well tolerated.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VA Office of Research and Development
• Collaborator: Oncovir, Inc.
• Treatments: Poly ICLC

Criteria

Inclusion Criteria:

• Veterans with advanced (stage IV) NSCLC

• Eligible to receive ICI/antiPD-1mAb

• No known mutation actionable for first line treatment

• An Eastern Cooperative Oncology Group (ECOG) performance-status (PS) score of 2 or less (ECOG PS is a 5-point scale in which higher scores reflect greater disability)

• Veterans' responses will be defined as eligible to enroll in HAITEN-ICIs if they meet all criteria

• To minimize the effects of immunosuppression on the ability to induce antitumor immunity, the investigators will recruit those who have not received systemic cytotoxic chemotherapy (e.g., platinum, taxane, pemetrexed, etc.), do not have major immunosuppression, and are not recipients of organ transplantation

• Based on our patient population at the MEDVAMC, the investigators estimate that ~30-40% of participants would be receiving systemic chemotherapy and ICIs concurrently, and ~60-70% will be receiving ICI monotherapy

• Therefore, the investigators anticipate no difficulty in meeting the recruitment goal of 16 persons at our center over two years and ~18 at each of the other sites over the 4-year study period

Exclusion Criteria:

Veterans with

• Concurrent other malignancies, except for localized prostate or localized skin cancer

• Uncontrolled rheumatologic diseases (such as rheumatoid arthritis)

• Current usage of biologics or immunosuppressive therapies

• Status post organ transplant

• An acute respiratory illness (pneumonia, bronchitis, upper respiratory tract infection) in the preceding 4 weeks