Phase III Study of Nazartinib (EGF816) Versus Erlotinib/Gefitinib in First-line Locally Advanced / Metastatic NSCLC With EGFR Activating Mutations

Sponsor
Novartis Pharmaceuticals
Study ID
NCT03529084
Phase
PHASE3
Status
Withdrawn

Conditions

  • Carcinoma, Non-small Cell Lung

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • EFG816 — DRUG
    It will be administered orally daily.
  • erlotinib or gefitinib — DRUG
    Investigator's choice between erlotinib or gefitinib. These will be locally sourced. Erlotinib will be administered orally daily. Gefitinib will be administered orally daily.

Study Details

This is a phase III, open label, randomized controlled multi-center global study designed to evaluate the safety and efficacy of single agent nazartinib (EGF816) compared with investigator's choice (erlotinib or gefitinib) in patients with locally advanced or metastatic NSCLC who are treatment naïve and whose tumors harbor EGFR activating mutations (L858R or ex19del).

Key Dates

First listed
May 18, 2018
Start date
Jul 24, 2018
Status verified
Nov 2019
Primary completion
Aug 13, 2020
Completion
Jun 3, 2024

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: EGF816
    Investigational treatment arm of EGF816 (nazartinib).
  • Active Comparator: Investigator's Choice
    Investigator's Choice (erlotinib or gefitinib).

Primary Outcome Measure

Progression Free Survival (PFS) by Blinded independent review committee (BIRC) [ Time Frame: Approximately 3 years ]

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