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

Terminated

• Conditions: Non Small Cell Lung Cancer

• Registration Number: NCT03951012
• Lead Sponsor: Muhammad Furqan

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.

Study Timeline

• Study Start: 2019-04-15
• Study First Submitted: 2019-04-17
• Study First Submitted QC: 2019-05-13
• Study First Posted: 2019-05-15
• Primary Completion: 2022-08-30
• Study Completion: 2023-09-08
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-10
• Last Update Posted: 2023-10-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 29

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Treatment toxicities	Time of study enrollment up to one year	The treatment toxicities will be recorded using CTCAE version 5.0
Treatment response	Time of study enrollment up to one year	Treatment response will be measured every 2-3 months using iRECIST criteria.
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.

Trial Locations

Locations (1)

University of Iowa Hospitals and Clinics; 🇺🇸 Iowa City, Iowa, United States