RecruitingPhase 2NCT07250477

Risk-adapted, Proteomic-guided Systemic Therapy for Previously Untreated Advanced Non-small Cell Lung Cancer


Sponsor

University of California, Davis

Enrollment

56 participants

Start Date

Jan 30, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study uses protein analysis (proteomics) to guide and personalize the selection of immune checkpoint-based treatments for patients with newly diagnosed advanced non-small cell lung cancer (NSCLC). Rather than giving everyone the same treatment, this approach uses detailed protein profiling to determine which combination may work best for each individual. **You may be eligible if...** - You are 18 or older - You have confirmed advanced (stage IIIC or IV) non-small cell lung cancer that cannot be surgically removed - You are a good candidate for standard immune checkpoint inhibitor-based therapy - You have not yet received treatment for metastatic disease (prior early-stage treatment is acceptable if finished more than 80 days ago) **You may NOT be eligible if...** - Your tumor has certain genetic mutations (in ALK, EGFR, HER2, MET exon 14, NTRK, RET, or ROS1) that would direct you to a targeted therapy instead - You have health conditions that prevent the safe use of immune checkpoint drugs - You have already received systemic treatment for stage IIIC or IV lung cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSystemic (ICI)-based therapy informed by the PROphet CB assay and the CARG-TT assessment.

Pretreatment assessment with PROphet CB and CARG-TT, which will be used to determine which first-line systemic treatment participants in the intervention arm receive. Systemic treatment will be pre-determined by the trial, according to the results from PROphet CB and CARG-TT.

DRUGStandard of Care

Standard of care (SOC) biomarker testing followed by first-line treatment with either anti-PD(L)1 Immune checkpoint inhibitor (ICI) monotherapy or anti-PD(L)1 ICI + chemotherapy.


Locations(4)

Enloe Health Regional Cancer Center

Chico, California, United States

Rideout Cancer Center

Marysville, California, United States

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

Tahoe Forest Cancer Center

Truckee, California, United States

View Full Details on ClinicalTrials.gov

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NCT07250477


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