Proteomic-guided, risk-adapted therapy for advanced non-small cell lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 2, pragmatic, open-label, 1:1 randomized trial comparing a proteomic-guided, risk-adapted approach to standard-of-care treatment selection in previously untreated advanced NSCLC. Participants in the intervention arm receive pretreatment assessments with the PROphet Clinical Benefit (CB) proteomic assay and the CARG-TT toxicity tool, and those results guide choice of any SOC regimen that includes a PD-(L)1 antibody with or without chemotherapy and/or a CTLA4 antibody. The control arm receives standard biomarker assessment and SOC systemic therapy selected per usual practice. The primary endpoint is progression-free survival at 12 months, with analyses stratified by performance status and tumor PD-L1 score.

Why it matters

Who can join: the full rules

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

Where it's running

• Enloe Health Regional Cancer Center
  Chico, California, United States Recruiting
• Rideout Cancer Center
  Marysville, California, United States Recruiting
• University of California Davis Comprehensive Cancer Center
  Sacramento, California, United States Recruiting
• Tahoe Forest Cancer Center
  Truckee, California, United States Recruiting

Study contacts

• Principal investigator: Surbhi Singhal, MD — University of California, Davis
• Study coordinator: Office of Clinical Research
• Email: OCRReferral@health.ucdavis.edu
• Phone: (916) 734-3772

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.