TerminatedNo phase
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
Key facts
- Who runs it
- Addario Lung Cancer Medical Institute
- Where
- Chicago and San Carlos, United StatesSee the 2 sites
- Trial code
- Status
- Terminated
- People taking part
- 29 people enrolled
- Started
- 1 Feb 2021
- Ended
- 30 Dec 2023
- Type of study
- Observational, 2 groups
- Treatments tested
- Primary Immune Response (PIR) test by Biodesix, Inc.
- Record updated
- 2 February 2024
- Why it stopped
- Recruitment futility
Who can take part
- Age
- 18 years to 70 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 5 criteriaShow less
Who can take part
- 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
Who cannot take part
- Ability to understand the requirements of the protocol or to provide informed consent is impaired or is unwilling to comply with the protocol requirements
Where in United States
- Rush University Medical CenterChicago, United StatesNo longer taking part
- Addario Lung Cancer Medical Institute (ALCMI)San Carlos, United StatesNo longer taking part
About the trial
What the trial wants to find out
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 score (TPS) > 50% and ECOG performance status (PS) 0-2 NSCLC patients who are treated with PD-1/PD-L1 based therapy with or without the addition of platinum based chemotherapy.
The 2 groups in the trial
- PD1/PD-L1
Standard of Care: PD1/PD-L1 monotherapy
Treatment: Primary Immune Response (PIR) test by Biodesix, Inc.
- PD1/PD-L1 + chemo
Standard of Care: Platinum doublet-based chemotherapy plus PD-1/PD-L1 combination
Treatment: Primary Immune Response (PIR) test by Biodesix, Inc.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 2 February 2024