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Risk-adapted Systemic Therapy for Advanced Non-small Cell Lung Cancer

This study is for people with advanced non-small cell lung cancer (stage IIIC or IV) who haven't received treatment yet. It's comparing two ways to decide on your first treatment. One group will have their treatment chosen based on special tests called PROphet CB and CARG-TT. The other group will receive standard biomarker testing to guide their treatment, which could be anti-PD(L)1 Immune checkpoint inhibitor (ICI) alone or with chemotherapy. The main goal is to see if the PROphet CB and CARG-TT guided approach helps people live longer without their cancer getting worse (progression-free survival) over 12 months. You can join if you are 18 or older and meet certain health criteria.

Study design
This is a phase 2, open-label study where about 56 participants will be randomly assigned to one of two treatment decision groups. It is designed to compare a new way of choosing treatment against the standard approach.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary goal is to measure how long participants live without their cancer getting worse for up to 12 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07250477

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
University of California, Davis
~56 participants
Updated 2026-08-25 on ClinicalTrials.gov
What's tested:Systemic (ICI)-based therapy informed by the PROphet CB assay and the CARG-TT assessment.Standard of Care

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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
Measured over Up to 12 months.

Conditions

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

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Lung Non-Small Cell Carcinoma

Where it's being run

4 sites across 1 states
California4

Study leadership

  • Surbhi Singhal, MD · PRINCIPAL_INVESTIGATOR · University of California, Davis

Who to contact

Office of Clinical Research
[email protected]
(916) 734-3772 · ext. 916-382-6970
Email the study team

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Eligibility criteria

Inclusion

Participants must have histologically confirmed non-small cell lung cancer that is metastatic or unresectable (stage IIIC or IV), deemed appropriate to receive standard of care immune checkpoint inhibitor-based therapy given with palliative intent.
Age ≥18 years at the time of consent.
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥50%).
Ability to understand and willingness to sign the informed consent form (ICF).
Stated ability and willingness to adhere to all protocol requirements while on study

Exclusion

Tumor with known sensitizing alteration in ALK, EGFR, HER2, MET exon 14, NTRK, RET, or ROS1.
Medical comorbidities precluding immune checkpoint inhibitor-based therapy per treating investgator's discretion.
Previous systemic therapy for metastatic Stage IIIC or IV NSCLC. Patients who previously completed systemic therapy for early stage or locally advanced NSCLC ≥ 80 days prior to trial registration are eligible for inclusion.
Any condition that in the opinion of the investigator would interfere with the participant's safety or compliance while on study

What this trial measures

  • 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 therapyUp to 12 months.

    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.