Lung Cancer Stage IV
Conditions
Brief summary
This prospective, observational study will evaluate whether vitro testing of tumor tissue and white blood cells from patients with lung cancer who are being treated with immune checkpoint inhibitors and other standard of care approaches, predicts clinical response to these agents.
Detailed description
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
Interventions
OTHERBlood and tumor tissue analysis, Clinical response.
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.
Sponsors
Holy Cross Hospital, Maryland
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anti-tumor immune response | 12 months | Tumor antigen presentation and anti-tumor T-cell response |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed