Non Small Cell Lung Cancer
Conditions
Brief summary
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
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.
Interventions
PROCEDUREBlood 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).
Sponsors
Biodesix, Inc.
Muhammad Furqan
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment response | Time of study enrollment up to one year | Treatment response will be measured every 2-3 months using iRECIST criteria. |
| Treatment toxicities | Time of study enrollment up to one year | The treatment toxicities will be recorded using CTCAE version 5.0 |
| Correlate peripheral blood proteomics data with patients' clinical information | Time of study enrollment up to one year | 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. |
Countries
United States
Outcome results
None listed