Use Peripheral Blood Proteomics to Predict the Treatment Response and Toxicities in NSCLC Immunotherapy

Study Overview
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Brief Summary
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Peripheral blood contains enormous quantity of biological information that can improve our patient care. Investigators plan to use proteomics from serum to study its value in predicting the therapeutic response and toxicities of immunotherapy in non-small cell lung cancer (NSCLC).

Detailed Description
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An extra tube of blood for research will be collected from consented subjects prior to the initiation of anti-PD-1/L1 based immunotherapy, either single agent or in combination with chemotherapy. The blood will be coded, processed and sent for analysis. Results of analysis will be correlated with clinical data to see whether serum proteomics can be a good therapeutic predictor for future studies and treatments of NSCLC.

Official Title
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Use Peripheral Blood Proteomics to Predict the Treatment Response and Toxicities in NSCLC Immunotherapy

Conditions
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Non Small Cell Lung Cancer

Intervention / Treatment
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* Procedure: Blood draw


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Non Small Cell Lung Cancer (NSCLC) patients who were previously untreated receiving anti-PD1 or anti-PD-L1 therapies, either single agent or in combination with chemotherapy. NSCLC patients who were treated with one previous line of therapy (not containing IO) and now receiving anti-PD1 or anti-PD-L1 therapies, either single agent or in combination with chemotherapy. Exclusion Criteria: Patients not capable of making medical decisions Any patients who do not meet the inclusion criteria

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Blood draw|Participants will be approached during their regular clinic visits and asked if an extra tube of blood may be collected prior to the treatment. If consent is not obtained before this visit, a participant will be asked later in the same day. The amount of blood collected will be 2 teaspoons (10mL).|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment response | Treatment response will be measured every 2-3 months using iRECIST criteria. | Time of study enrollment up to one year | 
| Treatment toxicities | The treatment toxicities will be recorded using CTCAE version 5.0 | Time of study enrollment up to one year | 
| Correlate peripheral blood proteomics data with patients' clinical information | An extra tube of peripheral blood ( 10ml) will be collected prior to the treatment. This blood specimen will be spun down and the serum collected and aliquoted.  1ml serum will be shipped to Biodesix Inc. for the analysis of blood proteomics using matrix-assisted laser/desorption ionization (MALDI) mass spectrometry. We will correlate proteomics data with patients clinical information including treatment response, toxicities, tumor mutation/PD-L1 status, etc. to determine if peripheral blood protemoics can predict therapeutic response. | Time of study enrollment up to one year |