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

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).

Study Overview

• Status: Terminated
• Conditions: Non Small Cell Lung Cancer
• Intervention / Treatment: Procedure: Blood draw

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 Type: Observational
• Enrollment (Actual): 29

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals and Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants are current patients at Holden Comprehensive Cancer Center undergoing immunotherapy for Non Small Cell Lung Cancer (NSLC) prior to first chemotherapy treatment.

Description

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 Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Muhammad Furqan
• Collaborators: Biodesix, Inc.
• Investigators: Principal Investigator: Taher Abu Hejleh, MBBS, University of Iowa

Publications and helpful links

General Publications

• Ascierto PA, Capone M, Grimaldi AM, Mallardo D, Simeone E, Madonna G, Roder H, Meyer K, Asmellash S, Oliveira C, Roder J, Grigorieva J. Proteomic test for anti-PD-1 checkpoint blockade treatment of metastatic melanoma with and without BRAF mutations. J Immunother Cancer. 2019 Mar 29;7(1):91. doi: 10.1186/s40425-019-0569-1.
• Quandt D, Dieter Zucht H, Amann A, Wulf-Goldenberg A, Borrebaeck C, Cannarile M, Lambrechts D, Oberacher H, Garrett J, Nayak T, Kazinski M, Massie C, Schwarzenbach H, Maio M, Prins R, Wendik B, Hockett R, Enderle D, Noerholm M, Hendriks H, Zwierzina H, Seliger B. Implementing liquid biopsies into clinical decision making for cancer immunotherapy. Oncotarget. 2017 Jul 18;8(29):48507-48520. doi: 10.18632/oncotarget.17397.

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2019
• Primary Completion (Actual): August 30, 2022
• Study Completion (Actual): September 8, 2023

Study Registration Dates

• First Submitted: April 17, 2019
• First Submitted That Met QC Criteria: May 13, 2019
• First Posted (Actual): May 15, 2019

Study Record Updates

• Last Update Posted (Actual): October 12, 2023
• Last Update Submitted That Met QC Criteria: October 10, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: 201710764

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No