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NCT03047616 Clinical Trial

A Pilot Study to Develop Predictive Biomarkers for the Response to Immunotherapy in Lung Cancer

Lung Cancer Clinical Trial

Official title:
A Pilot Study to Develop Predictive Biomarkers for the Response to Immunotherapy in Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03047616
Other study ID # 27516
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 22, 2016
Est. completion date May 31, 2019

Study information
Verified date April 2021
Source Abramson Cancer Center of the University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Several immune checkpoint inhibitors targeting the PD-1 pathway have been developed with clinical trials showing an approximately 20% durable response in unselected patients with advanced non-small cell lung cancer (NSCLC). At the moment, no clear biomarker exists to accurately predict anti-PD1/PDL1 tumor responsiveness. The goal of this study is to broadly discover and evaluate the utility of blood based biomarkers for use in measuring and predicting response to immunotherapy in patients with lung cancer.

Recruitment information / eligibility
Status Completed
Enrollment 88
Est. completion date May 31, 2019
Est. primary completion date January 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Advanced Metastatic NSCLC - Scheduled to initiate an immune checkpoint inhibitor - Age >= 18 years - Able to provide informed consent Exclusion Criteria: - Other, unrelated, concomitant active, invasive malignancy

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Blood and Urine Collection

Locations
Country Name City State
United States Abramson Cancer Center of the University of Pennsylvania Philadelphia Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
Abramson Cancer Center of the University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary the correlation between markers identified in the blood and in the primary tumor. 5 years
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