Recruiting
Phase 2

Systemic Therapy

Sponsor:

UCLA

Code:

NCT07250477

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

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

Standard of Care

Study Details

Brief 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.

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

Study ID

NCT07250477

Start date

Jan 30, 2026

Status verified date

Aug, 2026

Completion date

Dec, 2036

Anticipated

Primary completion date

May, 2036

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

56 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Systemic (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.

Standard 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.

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 and Locations

Central contacts

Office of Clinical Research

(916) 734-3772OCRReferral@health.ucdavis.edu

Locations

Enloe Health Regional Cancer Center

Recruiting

Chico, California, United States, 95926

Contacts

Ranjan Pathak, MD

530-332-7300ranjan.pathak@enloe.org

Principal Investigator:

Ranjan Pathak, MD

Rideout Cancer Center

Recruiting

Marysville, California, United States, 95901

Contacts

Hoa Nguyen, MD

530-749-4400nguyenh01@ah.org

Principal Investigator:

Hoa Nguyen, MD

University of California Davis Comprehensive Cancer Center

Recruiting

Sacramento, California, United States, 95817

Contacts

Surbhi Singhal, MD

916-734-3772susinghal@health.ucdavis.edu

Principal Investigator:

Surbhi Singhal, MD

Tahoe Forest Cancer Center

Recruiting

Truckee, California, United States, 96161

Contacts

Thomas Semrad, MD

530-582-6450tsemrad@tfhd.com

Principal Investigator:

Thomas Semrad, MD

More Information

Sponsor

University of California, Davis

Last update posted

Aug 25, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Davis on 2026-08-25.