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

NCT ID: NCT03951012

Last Updated: 2023-10-12

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 29 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-04-15
• Study Completion Date: 2023-09-08

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.

Conditions

Non Small Cell Lung Cancer

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

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).

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biodesix, Inc.

INDUSTRY

Sponsor Role: collaborator

Muhammad Furqan

OTHER

Sponsor Role: lead

Responsible Party

Muhammad Furqan

Clinical Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Taher Abu Hejleh, MBBS

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 30925943 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28501851 (View on PubMed)

Other Identifiers

201710764

Identifier Type: -

Identifier Source: org_study_id