drugset / Trial / NCT04285671

Necitumumab and Trastuzumab in Combination With Osimertinib for the Treatment of Refractory Epidermal Growth Factor Receptor (EGFR)-Mutated Stage IV Non-small Cell Lung Cancer

NCT04285671

NaSingle-groupOpen-labelTreatment

Summary

This phase Ib/II trial studies the side effects and best dose of trastuzumab and necitumumab together with osimertinib, and to see how well they work for the treatment of stage IV non-small cell lung cancer that is EGFR-mutated, resistant to osimertinib, and has not responded to previous treatment (refractory). Immunotherapy with monoclonal antibodies, such as trastuzumab and necitumumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving trastuzumab and necitumumab together with osimertinib may work better than osimertinib alone in treating patients with stage IV EGFR-mutated non-small cell lung cancer.

Timeline

Start
2021-01-29
Primary completion
2026-12-02
Completion
2027-12-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Necitumumab Monoclonal antibody Intravenous
Subject Osimertinib Small molecule Oral
Subject Trastuzumab Monoclonal antibody Intravenous