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

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.

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood and Urine Collection

Other

Primary outcomes

the correlation between markers identified in the blood and in the primary tumor.

Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Registry information

Important dates

Study start: 2016
Primary completion: 2019
Study completion: 2019
First posted: Feb 9, 2017
Registry last updated: Apr 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed