Risk-adapted, Proteomic-guided Systemic Therapy for Previously Untreated Advanced Non-small Cell Lung Cancer
Recruiting · NCT07250477 · Interventional (participants receive a specific treatment) · Lead sponsor: University of California, Davis
View the official record on ClinicalTrials.gov →Interventions studied
Standard of CareSystemic (ICI)-based therapy informed by the PROphet CB assay and the CARG-TT assessment.
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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 is running
4 locations listed across 1 US state.
- Enloe Health Regional Cancer Center - Chico, California, United States
- Rideout Cancer Center - Marysville, California, United States
- University of California Davis Comprehensive Cancer Center - Sacramento, California, United States
- Tahoe Forest Cancer Center - Truckee, California, United States