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

• Sponsor: Abramson Cancer Center of the University of Pennsylvania (Other)
• Overall Status: Completed
• CT.gov ID: NCT03047616
• Collaborator: (none)
• Enrollment: 88
• Location: 1
• Actual Duration (Months): 30.2
• Patients Per Site Per Month: 2.9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer	Other: Blood and Urine Collection

Study Design

• Study Type: Observational
• Actual Enrollment: 88 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: A Pilot Study to Develop Predictive Biomarkers for the Response to Immunotherapy in Lung Cancer
• Actual Study Start Date: Nov 22, 2016
• Actual Primary Completion Date: Jan 1, 2019
• Actual Study Completion Date: May 31, 2019

Outcome Measures

Primary Outcome Measures

1. the correlation between markers identified in the blood and in the primary tumor. [5 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• Abramson Cancer Center of the University of Pennsylvania

Investigators

• Principal Investigator: Charu Aggarwal, MD, Abramson Cancer Center of the University of Pennsylvania

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 25, 2018

More Information

Publications

None provided.

• Responsible Party: Abramson Cancer Center of the University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT03047616
• Other Study ID Numbers: 27516
• First Posted: Feb 9, 2017
• Last Update Posted: Apr 19, 2021
• Last Verified: Apr 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lung Neoplasms

Study Results

No Results Posted as of Apr 19, 2021