Actively Recruiting
Risk-adapted, Proteomic-guided Systemic Therapy for Previously Untreated Advanced Non-small Cell Lung Cancer
Led by University of California, Davis · Updated on 2026-02-09
56
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
Sponsors
U
University of California, Davis
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a phase 2, open-label, randomized study to compare risk-adapted, proteomic-guided systemic therapy against standard of care (SOC) treatment for patients with previously untreated advanced non-small cell lung cancer (NSCLC). The goal is to improve 12-month progression free survival (PFS) by selecting therapies based on specific risk assessments and biomarkers. This study focuses on patients with metastatic or unresectable NSCLC, considering tumor PD-L1 scores and participant performance status. Participants will be randomly assigned to either an intervention arm or a standard of care arm. Those in the intervention arm will have pretreatment assessments using the PROphet Clinical Benefit (CB) assay and the Cancer and Aging Research Group Toxicity Tool (CARG-TT), which guide the choice of systemic therapy. Treatments may include any SOC regimen that includes a PD-(L)1 antibody with or without chemotherapy and/or CTLA4 antibody. The SOC arm will receive biomarker testing followed by SOC systemic therapy, typically immune checkpoint inhibitor (ICI) monotherapy or ICI combined with chemotherapy. Throughout the study, participants will be monitored for up to 12 months for progression free survival and treatment-related adverse events, with additional follow-up extending to 60 months to assess overall survival and overall PFS. The study will include evaluations of time to treatment discontinuation and safety assessments at scheduled intervals. Participants will undergo regular clinical evaluations and biomarker assessments to track response and safety during and after treatment.
CONDITIONS
Brief Title
Risk-adapted, Proteomic-guided Systemic Therapy for Previously Untreated Advanced Non-small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have histologically confirmed metastatic or unresectable non-small cell lung cancer (stage IIIC or IV) appropriate for immune checkpoint inhibitor-based therapy with palliative intent.
- Age 18 years or older at the time of consent.
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less (Karnofsky score of 50% or higher).
- Ability to understand and willingness to sign the informed consent form.
- Willingness and ability to adhere to all study protocol requirements during participation.
You will not qualify if you...
- Tumor with known sensitizing alterations in ALK, EGFR, HER2, MET exon 14, NTRK, RET, or ROS1 genes.
- Medical conditions that prevent receiving immune checkpoint inhibitor-based therapy as determined by the treating investigator.
- Previous systemic therapy for metastatic stage IIIC or IV NSCLC. Patients who completed systemic therapy for earlier-stage NSCLC at least 80 days before enrollment are eligible.
- Any condition that the investigator believes would interfere with participant safety or study compliance.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants receive systemic immune checkpoint inhibitor-based therapy informed by PROphet CB and CARG-TT assessment or standard of care systemic therapy.
Regular visits for treatment and monitoring during therapy
Duration - Up to 48 months after treatment
Participants are monitored for progression free survival, overall survival, and treatment-related adverse events after treatment ends.
Periodic visits up to 60 months from treatment start
Trial Site Locations
Total: 1 location
1
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Actively Recruiting
Research Team
S
Surbhi Singhal, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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