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Clinical Trial 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 EGFR-mutant NSCLC.


Clinical Trial 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 will be 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 may be enrolled to the dose expansion arms of each of these combinations. Patients may also be assigned to EGF816 + INC280 or EGF816 + gefitinib in dose expansion. Efficacy assessments will be performed at baseline and every 2 cycles during treatment. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03333343
Study type Interventional
Source Novartis
Contact
Status Active, not recruiting
Phase Phase 1
Start date January 29, 2018
Completion date December 16, 2024

See also
  Status Clinical Trial Phase
Recruiting NCT03904823 - A Study of Famitinib in Combination With HS-10296 in Patients With EGFR-mutant NSCLC Phase 2