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

Non Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03951012
• Other study ID #: 201710764
• Status: Terminated
• Start date: April 15, 2019
• Est. completion date: September 8, 2023

Study information

• Verified date: October 2023
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 29
• Est. completion date: September 8, 2023
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non Small Cell Lung Cancer

Intervention

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).

Locations

Country	Name	City	State
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa

Sponsors (2)

Lead Sponsor	Collaborator
Muhammad Furqan	Biodesix, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment response	Treatment response will be measured every 2-3 months using iRECIST criteria.	Time of study enrollment up to one year
Primary	Treatment toxicities	The treatment toxicities will be recorded using CTCAE version 5.0	Time of study enrollment up to one year
Primary	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