Risk-adapted, Proteomic-guided Systemic Therapy for Previously Untreated Advanced Non-small Cell Lung Cancer
Purpose
This is a phase 2, pragmatic, 1:1 randomized, open-label study that evaluates risk-adapted, proteomic-guided systemic therapy to improve 12-month progression free survival (PFS) among patients with previously untreated advanced non-small cell lung cancer.
Conditions
- Non-small Cell Lung Cancer Stage IIIC
- Non-small Cell Lung Cancer Stage IV
- Non Small Cell Lung Cancer
- Non-small Cell Lung Cancer Metastatic
- Non-small Cell Lung Cancer Unresectable
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Participants must have histologically confirmed non-small cell lung cancer that is metastatic or unresectable (stage IIIC or IV), deemed appropriate to receive standard of care immune checkpoint inhibitor-based therapy given with palliative intent. - Age ≥18 years at the time of consent. - Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥50%). - Ability to understand and willingness to sign the informed consent form (ICF). - Stated ability and willingness to adhere to all protocol requirements while on study
Exclusion Criteria
- Tumor with known sensitizing alteration in ALK, EGFR, HER2, MET exon 14, NTRK, RET, or ROS1. - Medical comorbidities precluding immune checkpoint inhibitor-based therapy per treating investgator's discretion. - Previous systemic therapy for metastatic Stage IIIC or IV NSCLC. Patients who previously completed systemic therapy for early stage or locally advanced NSCLC ≥ 80 days prior to trial registration are eligible for inclusion. - Any condition that in the opinion of the investigator would interfere with the participant's safety or compliance while on study
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Systemic immune checkpoint inhibitor (ICI)-based therapy informed by PROphet CB and CARG-TT |
|
|
|
Active Comparator Standard of Care |
Standard of care (SOC) biomarker assessment and subsequent selection of SOC systemic therapy. |
|
Recruiting Locations
Chico, California 95926
Marysville, California 95901
Sacramento, California 95817
Truckee, California 96161
More Details
- Status
- Recruiting
- Sponsor
- University of California, Davis
Detailed Description
Participants will be randomized to an intervention arm or a standard of care (SOC) arm. Participants in the intervention arm will undergo pretreatment assessment with PROphet Clinical Benefit (CB) and the Cancer and Aging Research Group Toxicity Tool (CARG-TT); data from the assessments will be used to select systemic therapy, which can be any SOC treatment that incorporates a Programmed death-ligand 1 (PD-(L)1) antibody with or without chemotherapy and/or with or without Cytotoxic T-lymphocyte associated protein 4 (CTLA4) antibody. Participants in the SOC arm will undergo SOC biomarker assessment and subsequent selection of SOC systemic therapy. The primary endpoint is 12-month progression free survival (PFS). The findings will be stratified according to participant performance status and tumor PD-L1 score. The hypothesis is that risk-adapted, proteomic-guided systemic therapy will improve PFS among patients with previously untreated advanced NSCLC compared to SOC systemic therapy.