NCT03516214 (EATON) is a Phase 1 clinical trial of EGF816 in Bronchial Neoplasms, sponsored by University of Cologne.

Who is sponsoring NCT03516214?

NCT03516214 is sponsored by University of Cologne.

What drugs are being tested in NCT03516214?

Interventions in NCT03516214: EGF816, Trametinib.

What condition does NCT03516214 study?

NCT03516214 studies Bronchial Neoplasms.

Is NCT03516214 still recruiting?

NCT03516214 is currently completed. Last updated 15 February 2024.

Last reviewed 2024-02-15 · How we verify

NCT03516214: EATON

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Last updated 15 February 2024

What this trial tests

Phase 1 trial testing EGF816 in Bronchial Neoplasms in 18 participants. Completed in 27 November 2023.

Timeline

25 April 2018

Primary endpoint
30 September 2022

27 November 2023

Quick facts

Lead sponsor	University of Cologne
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	18
Start date	25 April 2018
Primary completion	30 September 2022
Estimated completion	27 November 2023
Sites	7 locations across Germany, Spain

Drugs / interventions tested

EGF816 — full drug profile →
Trametinib (trametinib) — full drug profile →

Conditions studied

Bronchial Neoplasms — all drugs for Bronchial Neoplasms →

Sponsor

University of Cologne

Who can join

Adults 18 to 99, any sex, with Bronchial Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Targeted therapy in advanced non-small cell lung cancer: current advances and future trends.
Majeed U, Manochakian R, Zhao Y, Lou Y. · · 2021 · cited 193× · PMID 34238332 · DOI 10.1186/s13045-021-01121-2
Third-generation epidermal growth factor receptor tyrosine kinase inhibitors for the treatment of non-small cell lung cancer.
Andrews Wright NM, Goss GD. · · 2019 · cited 66× · PMID 31857949 · DOI 10.21037/tlcr.2019.06.01
The Role of <i>TP53</i> Mutations in <i>EGFR</i>-Mutated Non-Small-Cell Lung Cancer: Clinical Significance and Implications for Therapy.
Canale M, Andrikou K, Priano I, Cravero P, et al · · 2022 · cited 57× · PMID 35267450 · DOI 10.3390/cancers14051143
Treating disease progression with osimertinib in EGFR-mutated non-small-cell lung cancer: novel targeted agents and combination strategies.
Di Noia V, D'Aveni A, D'Argento E, Rossi S, et al · · 2021 · cited 46× · PMID 34634633 · DOI 10.1016/j.esmoop.2021.100280
Mechanisms of resistance to tyrosine kinase inhibitor-targeted therapy and overcoming strategies.
Ou X, Gao G, Habaz IA, Wang Y. · · 2024 · cited 30× · PMID 39184861 · DOI 10.1002/mco2.694
Drug resistance of targeted therapy for advanced non-small cell lung cancer harbored EGFR mutation: from mechanism analysis to clinical strategy.
Zhao Y, Wang H, He C. · · 2021 · cited 26× · PMID 34661758 · DOI 10.1007/s00432-021-03828-8
Spectroscopic and molecular docking studies reveal binding characteristics of nazartinib (EGF816) to human serum albumin.
Almehizia AA, AlRabiah H, Bakheit AH, Hassan ESG, et al · · 2020 · cited 13× · PMID 32218978 · DOI 10.1098/rsos.191595
A Closer Look at EGFR Inhibitor Resistance in Non-Small Cell Lung Cancer through the Lens of Precision Medicine.
Sattler M, Mambetsariev I, Fricke J, Tan T, et al · · 2023 · cited 12× · PMID 36902723 · DOI 10.3390/jcm12051936

Verify or expand the search:

Other trials of EGF816

Trials testing the same drug.

NCT03333343 — Study of EGF816 in Combination With Selected Targeted Agents in EGFR-mutant NSCLC · Phase 1 · active not recruiting
NCT03292133 — A Study of EGF816 and Gefitinib in TKI-naïve EGFR-mutant Non-Small Cell Lung Cancer · Phase 2 · terminated
NCT02900664 — A Study of PDR001 in Combination With CJM112, EGF816, Ilaris® (Canakinumab) or Mekinist® (Trametinib) · Phase 1 · completed
NCT02323126 — Study of Efficacy and Safety of Nivolumab in Combination With EGF816 and of Nivolumab in Combination With INC280 in Pati · Phase 2 · terminated
NCT02108964 — A Phase I/II, Multicenter, Open-label Study of EGFRmut-TKI EGF816, Administered Orally in Adult Patients With EGFRmut So · Phase 1, PHASE2 · completed

Other recruiting trials for Bronchial Neoplasms

Currently open trials in the same condition.

NCT06494241 — Small/Middle Tier Cities and County Lung Cancer Quality Improvement Project (QIP) Study · active not recruiting
NCT06376084 — Osimertinib With Chemotherapy as First-line Therapy for EGFR Mutation-positive NSCLC · active not recruiting
NCT06177925 — A Phase Ⅱ Clinical Study of Adebrelimab Combined With Chemotherapy and Concurrent Radiotherapy for Extensive-Stage Oligo · Phase 2 · recruiting

Other University of Cologne trials

Trials by the same sponsor.

NCT07280585 — STOP-PKD: SGLT2-inhibition to Improve Prognosis in Polycystic Kidney Disease · Phase 3 · recruiting
NCT06612515 — Vaccine-induced Immunity in Immunocompromised Patients · recruiting
NCT06781710 — Analysis of the Epidemiology, Clinical Presentation and Therapy as Well as Therapy-associated Risk of Demyelination Synd · recruiting
NCT05969431 — Hair Cortisol as Marker of Chronic Stress in Preterm and Term Fathers - Fathair-study · recruiting
NCT05876221 — Platelet Response to Caplacizumab in the Treatment of Acquired Thrombotic Thrombocytopenic Purpura · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03516214 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Cologne
Last refreshed: 15 February 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03516214.

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