Spots Global Cancer Trial Database for NOV120101 (Poziotinib) for 1st Line Monotherapy in Patients With Lung Adenocarcinoma

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Trial Identification

Brief Title: NOV120101 (Poziotinib) for 1st Line Monotherapy in Patients With Lung Adenocarcinoma

Official Title: A Prospective, Open-label, Single Arm, Multi-center, Phase II Exploratory Trial to Evaluate the Efficacy and Safety of NOV120101 (Poziotinib) as the First-line Treatment Medication in Patients With Harboring EGFR Mutations

Study ID: NCT01819428

Conditions

Adenocarcinoma of Lung Stage IIIB

Adenocarcinoma of Lung Stage IV

Interventions

NOV120101 (Poziotinib)

Study Description

Brief Summary: The purpose of this open-label, single-arm, multi-center phase II trial is to evaluate the efficacy and safety of novel pan-HER inhibitor, NOV120101 (Poziotinib), as a first-line monotherapeutic agent in patients with lung adenocarcinoma harboring EGFR mutation.

Detailed Description: EGFR TKIs are known as more effective and less toxic medications against EGFR mutated tumors. However, newly acquired resistance to these inhibitors is the inevitable obstacle in continuous treatment with them. To overcome this problem, many new class of TKIs including NOV120101 (Poziotinib) are developing these days. To evaluate the efficacy of NOV120101 (Poziotinib) as a first-line monotherapeutic medication, chemotherapy-naïve patients will participate in this study. Subjects will receive NOV120101 (Poziotinib) 12 mg PO once daily until disease progression or unacceptable toxicity development. Objective response rate (ORR) will be analyzed as the primary endpoint in this trial. Secondary endpoints including PFS rate at 12 months, DCR, PFS, and OS will also be analyzed.