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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03047616

Enrollment

Registered

2017-02-09

Start date

2016-11-22

Completion date

2019-05-31

Last updated

2021-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

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.

Interventions

OTHERBlood and Urine Collection

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
the correlation between markers identified in the blood and in the primary tumor.	5 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026