A Pilot Study to Develop Predictive Biomarkers for the Response to Immunotherapy in Lung Cancer
1 other identifier
observational
88
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2016
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 22, 2016
CompletedFirst Submitted
Initial submission to the registry
February 6, 2017
CompletedFirst Posted
Study publicly available on registry
February 9, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2019
CompletedApril 19, 2021
April 1, 2021
2.1 years
February 6, 2017
April 15, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
the correlation between markers identified in the blood and in the primary tumor.
5 years
Interventions
Eligibility Criteria
Adults with non-small cell lung cancer (NSCLC)
You may qualify if:
- Advanced Metastatic NSCLC
- Scheduled to initiate an immune checkpoint inhibitor
- Age \>= 18 years
- Able to provide informed consent
You may not qualify if:
- Other, unrelated, concomitant active, invasive malignancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Related Publications (1)
Aggarwal C, Thompson JC, Chien AL, Quinn KJ, Hwang WT, Black TA, Yee SS, Christensen TE, LaRiviere MJ, Silva BA, Banks KC, Nagy RJ, Helman E, Berman AT, Ciunci CA, Singh AP, Wasser JS, Bauml JM, Langer CJ, Cohen RB, Carpenter EL. Baseline Plasma Tumor Mutation Burden Predicts Response to Pembrolizumab-based Therapy in Patients with Metastatic Non-Small Cell Lung Cancer. Clin Cancer Res. 2020 May 15;26(10):2354-2361. doi: 10.1158/1078-0432.CCR-19-3663. Epub 2020 Feb 26.
PMID: 32102950DERIVED
Biospecimen
Collection of blood and urine specimens from patients receiving immunotherapy as part of their standard of care for the treatment of NSCLC
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Charu Aggarwal, MD
Abramson Cancer Center at Penn Medicine
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 6, 2017
First Posted
February 9, 2017
Study Start
November 22, 2016
Primary Completion
January 1, 2019
Study Completion
May 31, 2019
Last Updated
April 19, 2021
Record last verified: 2021-04