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(1)

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

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NCT07250477


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