A Phase 2 interventional study of Systemic (ICI)-based therapy informed by the PROphet CB assay and the CARG-TT assessment. and Standard of Care in Non-small Cell Lung Cancer Stage IIIC, Non-small Cell Lung Cancer Stage IV and Non Small Cell Lung Cancer, sponsored by University of California, Davis. Recruiting at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-25.
Sponsored by University of California, Davis · Phase 2, Interventional, and Treatment
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.
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.
6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.
This study's planned enrollment of 56 is close to the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →University of California, Davis is the lead sponsor of 798 studies on the registry; 146 are open to participants now.
Of its 65 completed or terminated interventional studies of FDA-regulated products, 43 (66%) have results posted.
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Exclusion Criteria:
Drug: Systemic (ICI)-based therapy informed by the PROphet CB assay and the CARG-TT assessment.
Standard of care (SOC) biomarker assessment and subsequent selection of SOC systemic therapy.
Drug: Standard of Care
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 (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.
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
Progression free survival (PFS) at 12 months, defined as progression assessed per investigator using Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 or death due to any cause at 12 months (± 28 days) from start of treatment.
Time frame: Up to 12 months.
To evaluate treatment-related adverse events of systemic therapy informed by PROphet CB and CARG-TT (intervention arm) versus standard of care systemic therapy.
* Grade ≥3 treatment-related adverse events from chemotherapy classified and graded per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 * Grade ≥2 treatment-related adverse events from immune checkpoint inhibitors classified and graded per NCI CTCAE v5.0 * Number of dose delays, dose reductions, and/or dose discontinuations for treatment-related adverse event * Initiation and dose of systemic steroids for possible immune-related adverse event
Time frame: 3, 6, 9, and 12 months
To evaluate time to treatment discontinuation of systemic therapy informed by PROphet CB and CARG-TT (intervention arm) versus standard of care systemic therapy
Time from the start of treatment to the date of treatment discontinuation or death due to any cause, whichever occurs first
Time frame: Up to 12 months
To evaluate overall PFS of systemic therapy informed by PROphet CB and CARG-TT (intervention arm) versus standard of care systemic therapy.
Overall progression free survival (PFS) defined as the time from the start of treatment to the first date of the progression (any progression assessed per investigator using RECIST v1.1) or death due to any cause, whichever occurs first.
Time frame: Up to 60 months.
To evaluate overall survival (OS) among participants treated with systemic therapy informed by PROphet CB and CARG-TT (intervention arm) versus standard of care systemic therapy.
Overall survival (OS) defined as the time from the start of treatment to death due to any cause or 60 months, whichever occurs first.
Time frame: Up to 60 months.
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Carcinoma, Non-Small-Cell Lung→
University of California, Davis