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

NCT03516214 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2024-02-15

No results posted yet for this study

Summary

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).

Conditions

  • Bronchial Neoplasms

Interventions

DRUG

EGF816

Continuous oral treatment (once daily) with the 3rd generation EGFR inhibitor EGF816.

DRUG

Trametinib

Continuous oral treatment (once daily) with the MEK inhibitor trametinib.

Sponsors & Collaborators

  • University of Cologne

    lead OTHER

Principal Investigators

  • Jürgen Wolf, Prof. Dr. · University Hospital of Cologne

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-25
Primary Completion
2022-09-30
Completion
2023-11-27
FDA Drug
Yes

Countries

  • Germany
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03516214 on ClinicalTrials.gov