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

Part of paid clinical trials in Sacramento, California.

Sponsor
University of California, Davis
Study ID
NCT07250477
Phase
PHASE2
Status
Recruiting
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Conditions

  • Non Small Cell Lung Cancer
  • Non-small Cell Lung Cancer Metastatic
  • Non-small Cell Lung Cancer Stage IIIC
  • Non-small Cell Lung Cancer Stage IV
  • Non-small Cell Lung Cancer Unresectable

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Systemic (ICI)-based therapy informed by the PROphet CB assay and the CARG-TT assessment. — DRUG
    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.
  • Standard of Care — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jan 30, 2026
Status verified
Feb 2026
Primary completion
May 31, 2036
Completion
Dec 31, 2036

Study Design

Enrollment
56 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

The primary objective is to evaluate 12-month progression free survival (PFS) of systemic therapy informed by PROphet CB and CARG-TT (intervention arm) versus standard of care systemic therapy [ Time Frame: Up to 12 months. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California Davis Comprehensive Cancer CenterSacramentoCalifornia95817
Surbhi Singhal, MD
[email protected]
916-734-3772
Surbhi Singhal, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Sacramento, CA

By condition
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By specialty
OncologyLung oncologyLung disease
By research site
University of California Davis Comprehensive Cancer Center· Sacramento, CA

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