Status:
TERMINATED
Biomarker Analysis in High PD-L1 Expressing NSCLC Patients Treated With PD-1/PD-L1 Based Therapy With or Without the Addition of Platinum Based Chemotherapy
Lead Sponsor:
Addario Lung Cancer Medical Institute
Collaborating Sponsors:
Biodesix, Inc.
Conditions:
NSCLC Stage IV
NSCLC, Stage IIIC
Eligibility:
All Genders
18-70 years
Brief Summary
This Observational study will explore the utility of the Biodesix, Inc. "PIR" (primary immune response) test to predict outcomes in treatment-naïve advanced stage NSCLC with PD-L1 tumor proportion sco...
Detailed Description
This is an observational, multicenter study designed to assess biomarkers (serum and plasma) as predictive of early progression in 390 treatment-naive patients with advanced stage non-small cell lung ...
Eligibility Criteria
Inclusion
- Treatment naïve for their stage IIIC/IV AJCC 8 non-small cell lung cancer with a tumor biopsy PD-L1 TPS \> 50%
- Intent to treat with PD-1/PD-L1 or PD-1/PD-L1 plus pemetrexed/carboplatin or paclitaxel/nab-paclitaxel/carboplatin
- ECOG PS 0-2
- Ability to consent to participate in the study
Exclusion
- Ability to understand the requirements of the protocol or to provide informed consent is impaired or is unwilling to comply with the protocol requirements
Key Trial Info
Start Date :
February 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 30 2023
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT04676386
Start Date
February 1 2021
End Date
December 30 2023
Last Update
February 2 2024
Active Locations (2)
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1
Addario Lung Cancer Medical Institute (ALCMI)
San Carlos, California, United States, 94070
2
Rush University Medical Center
Chicago, Illinois, United States, 60612