Proteomic-guided, risk-adapted therapy for advanced non-small cell lung cancer
Risk-adapted, Proteomic-guided Systemic Therapy for Previously Untreated Advanced Non-small Cell Lung Cancer
This trial tests whether using a proteomic test plus a toxicity risk tool to pick immune checkpoint inhibitor–based treatment can improve 12-month progression-free survival for people with previously untreated advanced non-small cell lung cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, Davis Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Sacramento, California) |
| Trial ID | NCT07250477 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults with histologically confirmed unresectable or metastatic (stage IIIC/IV) NSCLC who are eligible for PD-(L)1–based therapy, have ECOG performance status 0–2, and have not received prior systemic therapy for advanced disease.
Not a fit: Patients with known sensitizing driver mutations (ALK, EGFR, HER2, MET exon 14, NTRK, RET, ROS1), those with medical contraindications to immune checkpoint inhibitors, or those who have already received prior systemic therapy for metastatic disease are unlikely to benefit from enrollment.
Why it matters
Potential benefit: If successful, this approach could increase the number of patients who are progression-free at 12 months by better matching treatment intensity to an individual’s proteomic risk and toxicity vulnerability.
How similar studies have performed: PD-(L)1 immunotherapies are proven effective in advanced NSCLC, but using proteomic-guided treatment selection combined with a toxicity risk tool is a relatively novel approach with limited randomized evidence to date.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Sacramento, California
- University of California Davis Comprehensive Cancer Center — Sacramento, California, United States (Recruiting)
Study contacts
- Principal investigator: Surbhi Singhal, MD — University of California, Davis
- Study coordinator: Surbhi Singhal, MD
- Email: susinghal@health.ucdavis.edu
- Phone: (916) 734-3772
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.