NCT03333343

Study of EGF816 in Combination With Selected Targeted Agents in EGFR-mutant NSCLC

A Phase Ib, Open Label, Multi-center Study to Characterize the Safety, Tolerability and Preliminary Efficacy of EGF816 in Combination With Selected Targeted Agents in EGFR Mutant NSCLC

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The study purpose is to evaluate the safety, tolerability, and preliminary efficacy of the addition of INC280, trametinib, ribociclib, gefitinib, or LXH254 to EGF816 in adult patients with advanced Epidermal growth factor receptor- mutant (EGFR-mutant) non-small cell lung cancer (NSCLC).

Detailed description

This is a Phase Ib, open label, non-randomized dose escalation study of EGF816 in combination with ribociclib, trametinib, or LXH254, followed by dose expansion of EGF816 in combination with ribociclib, trametinib, LXH254, INC280, or gefitinib in adult patients with advanced EGFR-mutant NSCLC. During the dose escalation part, patients were assigned to the addition of trametinib, ribociclib, or LXH254 to EGF816. Following determination of the recommended dose for the combination of EGF816 + trametinib, EGF816 + ribociclib, and EGF816 + LXH254, patients could be enrolled to the dose expansion arms of each of these combinations. Patients could also be assigned to EGF816 + INC280. The planned arm EGF816 + gefitinib in dose expansion was not opened for enrollment.

Conditions

• EGFR-mutant Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	EGF816	Study Drug
DRUG	trametinib	Study Drug
DRUG	ribociclib	Study Drug
DRUG	LXH254	Study Drug
DRUG	INC280	Study Drug
DRUG	gefitinib	Study Drug

Timeline

• Start date: 2018-01-29
• Primary completion: 2026-10-05
• Completion: 2026-10-05
• First posted: 2017-11-06
• Last updated: 2026-01-16

Locations

11 sites across 6 countries: Canada, Germany, Hong Kong, Italy, Singapore, Taiwan