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

NCT04676386 | Terminated

• 1 other identifier: ALCMI-014
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 2

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 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.

Conditions

NSCLC Stage IV; NSCLC, Stage IIIC

Outcome Measures

Primary Outcomes (1)

• Biomarker PIR evaluation

  To collect biospecimens and evaluate candidate biomarkers of early progression on patients with \>50% PD-L1 positive tumors treated with PD-1/PD-L1 monotherapy or PD-1/PD-L1/chemotherapy combination

  3 years

Study Arms (2)

PD1/PD-L1

Standard of Care: PD1/PD-L1 monotherapy

Diagnostic Test: 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

Diagnostic Test: Primary Immune Response (PIR) test by Biodesix, Inc.

Interventions

Primary Immune Response (PIR) test by Biodesix, Inc. DIAGNOSTIC_TEST

Blood draw for biomarker assessment will be performed at these time-points: pretreatment, start of 3rd cycle and investigator assessed progression. The biomarker analysis will be performed retrospectively.

PD1/PD-L1; PD1/PD-L1 + chemo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Eligible patients will be treatment-naïve advanced NSCLC patients with PD-L1 TPS ≥50% who will receive PD-1/PD-L1 or PD-1/PD-L1 plus pemetrexed/carboplatin or paclitaxel/nab-paclitaxel/carboplatin and are managed per treating physician's standard of care.

You may qualify if:

• 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

You may not qualify if:

• Ability to understand the requirements of the protocol or to provide informed consent is impaired or is unwilling to comply with the protocol requirements

Sponsors & Collaborators

• Addario Lung Cancer Medical Institute: lead
• Biodesix, Inc.: collaborator

Study Sites (2)

Addario Lung Cancer Medical Institute (ALCMI)

San Carlos, California, 94070, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

A maximum of three blood draws will be performed over three years. Approximately 25 mLs venous blood will be collected into blood collection tubes provided in the study kit. Blood should be drawn at the time of other clinical laboratories whenever possible to prevent additional venipuncture or port access, otherwise, a study-specific blood draw may occur at the time of the standard of care office visit. Peripheral blood draws may occur on-site or via a remote phlebotomist dispatched by the enrolling institution. Sites may mail the blood draw kit to the subject prior to arrival of the remote phlebotomist.

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2020
• First Posted: December 21, 2020
• Study Start: February 1, 2021
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: February 2, 2024

Record last verified: 2024-02

Locations

US (2)