drugset / Trial / NCT06067776

Osimertinib, Cetuximab, and Tucatinib for the Treatment of EGFR-Mutant Stage IV or Recurrent Non-small Lung Cell Cancer

NCT06067776

Phase 1 Not yet recruiting 36 enrolled Jonathan Riess National Cancer Institute (NCI) · collab
NaSingle-groupOpen-labelTreatment

Summary

This phase I trial tests the safety, side effects, and best dose of osimertinib, cetuximab, and tucatinib in treating patients with EFGR-mutant non-small cell lung cancer that is stage IV or has come back (recurrent). Osimertinib and tucatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Cetuximab is a chimeric human/mouse IgG1 monoclonal antibody that targets epidermal growth factor receptor (EGFR), a receptor overexpressed in many types of cancer, and may interfere with the ability of tumor cells to grow and spread. Giving osimertinib, cetuximab, and tucatinib may work better in treating patients with non-small cell lung cancer.

Timeline

Start
2024-01-01
Primary completion
2025-01-01
Completion
2026-11-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Cetuximab Monoclonal antibody 250 mg/m2 Intravenous
Subject Osimertinib Small molecule 80 mg Oral
Subject Tucatinib Small molecule 200 mg Oral