Phase 2 Study of Risk-Adapted Proteomic-Guided Systemic Therapy Versus Standard Treatment for Advanced Non-Small Cell Lung Cancer

What this Trial Is About

Researchers are evaluating a phase 2, open-label, randomized study to compare risk-adapted, proteomic-guided systemic therapy against standard of care SOC treatment for patients with previously untreated advanced non-small cell lung cancer NSCLC. The goal is to improve 12-month progression free survival PFS by selecting therapies based on specific risk assessments and biomarkers. This study focuses on patients with metastatic or unresectable NSCLC, considering tumor PD-L1 scores and participant performance status. Participants will be randomly assigned to either an intervention arm or a standard of care arm. Those in the intervention arm will have pretreatment assessments using the PROphet Clinical Benefit CB assay and the Cancer and Aging Research Group Toxicity Tool CARG-TT, which guide the choice of systemic therapy. Treatments may include any SOC regimen that includes a PD-L1 antibody with or without chemotherapy andor CTLA4 antibody. The SOC arm will receive biomarker testing followed by SOC systemic therapy, typically immune checkpoint inhibitor ICI monotherapy or ICI combined with chemotherapy. Throughout the study, participants will be monitored for up to 12 months for progression free survival and treatment-related adverse events, with additional follow-up extending to 60 months to assess overall survival and overall PFS. The study will include evaluations of time to treatment discontinuation and safety assessments at scheduled intervals. Participants will undergo regular clinical evaluations and biomarker assessments to track response and safety during and after treatment.

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