Personalizing Immune Checkpoint Inhibitor Therapy

Overall Goal: The long-term goal of this study is to predict whether checkpoint inhibitors will be effective in individual patients with solid tumors.

Objectives: In this pilot study to be conducted in ten subjects with lung cancer who are to receive checkpoint inhibitors, we will use cellular and molecular techniques to characterize

* tumor immunogenicity
* anti-tumor T-cell response
* effect of checkpoint inhibitors on antigen presentation and T-cell response, and
* the tumor microenvironment

Planned enrollment:

• Ten subjects with lung cancer

Methods for Informed Consent:

Investigators will approach subjects for informed consent

• Blood and tumor tissue analysis, Clinical response. (Other): DNA sequencing and functional testing of peripheral blood mononuclear cells. DNA and RNA sequencing and immune cell analysis of tumor. Clinical response at 12 months.

Primary outcomes

• Anti-tumor immune response [12 months]: Tumor antigen presentation and anti-tumor T-cell response

Secondary outcomes

• Clinical response [12 months for each subject]: Clinical response is defined as 50% or greater decrease of the sum of the products of two-dimensional measurements of lesions on imaging within the first year.
• Tumor microenvironment [24 months total study duration]: Tumor mutation burden from tumor genome landscape using DNA sequencing, tumor transcriptome with RNA sequencing, tumor infiltrating immune cells with flow cytometry

Sex: All, ages: 18 Years to 70 Years

Inclusion Criteria:

* Subjects with lung cancer about to undergo diagnostic/excisional biopsy with the intent to receive therapy with immune checkpoint inhibitors
* Availability of fresh tumor tissue removed at excisional biopsy or diagnostic biopsy
* Informed consent

Exclusion Criteria:

• Lack of informed consent

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