EGF816 and Trametinib in Patients With Non-small Cell Lung Cancer Harboring Activating EGFR Mutations

Conditions

• Bronchial Neoplasms

Eligibility Criteria

Sex

ALL

Age

18 Years - 99 Years

Healthy Volunteers

Not accepted

Interventions

• EGF816 — DRUG
  Continuous oral treatment (once daily) with the 3rd generation EGFR inhibitor EGF816.
• Trametinib — DRUG
  Continuous oral treatment (once daily) with the MEK inhibitor trametinib.

Study Details

The aim of this trial is to identify the maximum tolerated dose (MTD)/recommended phase II dose (RP2D), to define pharmacokinetic (PK) parameters and the preliminary efficacy of a continuous treatment with EGF816 and trametinib in locally advanced or metastatic (stage IIIB or IV) lung cancer patients with activating mutations in the epithelial growth factor receptor (EGFR).

Key Dates

Start date

Apr 25, 2018

Status verified

Feb 2024

Primary completion

Sep 30, 2022

Completion

Nov 27, 2023

Study Design

Enrollment

18 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: EGF816 (nazartinib) and trametinib
  Patients will receive oral EGF816 (nazartinib) and trametinib at escalating dose levels. Intra-patient dose-escalation will not be allowed.

Primary Outcome Measure

Incidence of dose-limiting-toxicities (DLT) of the combination of EGF816 and trametinib to assess the maximum tolerated dose (MTD)/recommended phase II dose (RP2D) [ Time Frame: Approximately one and a half years (from FPFV until the end of the DLT period of the last patient included into the trial or until death of the last patient, whichever occurs first) ]