EGF816

DRUG8 trials

Sponsors

Novartis Pharma AG, Novartis Pharmaceuticals, Massachusetts General Hospital, University of Cologne

Conditions

Advanced Non-small Cell Lung CancerBronchial NeoplasmsColorectal Cancer, Triple Negative Breast Cancer, NSCLC - AdenocarcinomaDifferent types of advanced cancerEGFR-mutant Non-small Cell Lung CancerLung CancerNon Small Cell Lung CancercMET-dependent malignancies

Phase 1

A Phase I/II, Multicenter, Open-label Study of EGFRmut-TKI EGF816, Administered Orally in Adult Patients With EGFRmut Solid Malignancies

CompletedNCT02108964

Novartis PharmaceuticalsAdvanced Non-small Cell Lung Cancer

Start: 2014-06-06End: 2023-08-15Updated: 2024-12-11

A Study of PDR001 in Combination With CJM112, EGF816, Ilaris® (Canakinumab) or Mekinist® (Trametinib)

CompletedNCT02900664

Novartis PharmaceuticalsColorectal Cancer, Triple Negative Breast Cancer, NSCLC - Adenocarcinoma

Start: 2016-08-23End: 2021-03-17Updated: 2022-03-29

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

Active, not recruitingNCT03333343

Novartis PharmaceuticalsEGFR-mutant Non-small Cell Lung Cancer

Start: 2018-01-29End: 2026-10-05Updated: 2026-01-16

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

CompletedNCT03516214

University of CologneBronchial Neoplasms

Start: 2018-04-25End: 2023-11-27Updated: 2024-02-15

An open-label, multi-center rollover protocol for patients who have participated in a Novartis-sponsored ribociclib (LEE011) study and are continuing to benefit from ribociclib as single agent or in combination with other investigational treatments

RecruitingCTIS2024-511125-61-00

Novartis Pharma AGDifferent types of advanced cancer

Start: 2017-03-08Target: 2Updated: 2025-12-10

Phase 2

Study of Efficacy and Safety of Nivolumab in Combination With EGF816 and of Nivolumab in Combination With INC280 in Patients With Previously Treated Non-small Cell Lung Cancer

TerminatedNCT02323126

Novartis PharmaceuticalsNon Small Cell Lung Cancer

Start: 2015-02-09End: 2021-02-05Updated: 2022-02-28

A Study of EGF816 and Gefitinib in TKI-naïve EGFR-mutant Non-Small Cell Lung Cancer

TerminatedNCT03292133

Massachusetts General HospitalLung Cancer

Start: 2017-10-31End: 2025-03-04Updated: 2025-06-10

An open-label, multi-center, global, rollover study for patients who have previously been treated with capmatinib (INC280) as monotherapy or in combination in a Novartis Sponsored trial

Active, not recruitingCTIS2024-510948-31-00

Novartis Pharma AGcMET-dependent malignancies

Start: 2017-07-04Target: 11Updated: 2025-12-22

Related Papers

EATON: A phase I trial of nazartinib (EGF816) and trametinib in EGFR-mutant (EGFRmut) non-small cell lung cancer (NSCLC).

Journal of Clinical Oncology2025-05-281 citations

Capmatinib plus nivolumab in pretreated patients with EGFR wild-type advanced non-small cell lung cancer.

2024-05-106 citations

Nazartinib for treatment-naive EGFR-mutant non-small cell lung cancer: Results of a phase 2, single-arm, open-label study.

2022-07-0713 citations

Abstract CT255: EATON: A phase I dose-escalation trial of nazartinib (EGF816) and trametinib in EGFR-mutant NSCLC

Cancer Research2020-08-15

Nazartinib (EGF816) in patients with treatment-naïve <i>EGFR</i>-mutant non-small cell lung cancer (NSCLC): Updated phase II results.

Journal of Clinical Oncology2020-05-204 citations

Safety and efficacy of nazartinib (EGF816) in adults with EGFR-mutant non-small-cell lung carcinoma: a multicentre, open-label, phase 1 study.

2020-01-1543 citations

EATON: An open-label, multicenter, phase I dose-escalation trial of nazartinib (EGF816) and trametinib in patients with EGFR-mutant non-small cell lung cancer – preliminary data on safety and tolerability.

Journal of Clinical Oncology2019-05-201 citations

Preliminary Phase II results of a multicenter, open-label study of nazartinib (EGF816) in adult patients with treatment-naïve <i>EGFR</i>-mutant non-small cell lung cancer (NSCLC).

Journal of Clinical Oncology2018-05-2015 citations

Genomic profiling of resistant tumor samples following progression on EGF816, a third generation, mutant-selective EGFR tyrosine kinase inhibitor (TKI), in advanced non-small cell lung cancer (NSCLC).

Journal of Clinical Oncology2017-05-2013 citations

Response to osimertinib following treatment with EGF816 in patients with T790M EGFR mutant NSLCLC.

Journal of Clinical Oncology2017-05-206 citations

Outcome of EGFR mutant patirnts included in a clinical trial after progression on EGFR TKI.

Journal of Clinical Oncology2017-05-201 citations

Updated results of a phase 1 study of EGF816, a third-generation, mutant-selective EGFR tyrosine kinase inhibitor (TKI), in advanced non-small cell lung cancer (NSCLC) harboring T790M.

Journal of Clinical Oncology2016-05-2040 citations

First-in-human phase I study of EGF816, a third generation, mutant-selective EGFR tyrosine kinase inhibitor, in advanced non-small cell lung cancer (NSCLC) harboring T790M.

Journal of Clinical Oncology2015-05-2028 citations