This is an open-label, single-arm, multicenter phase II trial in patients with stage IV EGFR T790M, EGFR exon 20 and other uncommon, HER2, or BRAF-mutated; ALK, ROS1, or RET-rearranged NSCLC.
Study Design: This is an open-label, single-arm, multicenter phase II trial in patients with stage IV EGFR T790M, EGFR exon 20 and other uncommon, HER2, or BRAF-mutated; ALK, ROS1, or RET-rearranged NSCLC (n = 9 x 7) Objectives: Primary objective(s): To define the objective response rate by RECIST 1.1 of AUY922 in patients with stage IV EGFR T790M, EGFR exon 20 and other uncommon, HER2, or BRAF-mutated; ALK, ROS1, or RET-rearranged NSCLC Secondary objective(s): (1) To define the disease control rate (complete response + partial response + stable disease \>=24 weeks) of AUY922 in patients with stage IV EGFR T790M, EGFR exon 20 and other uncommon, HER2, or BRAF-mutated; ALK, ROS1, or RET-rearranged NSCLC. (2) To determine the progression-free survival of AUY922 in patients with stage IV EGFR T790M, EGFR exon 20 and other uncommon, HER2, KRAS, or BRAF-mutated; ALK, ROS1, or RET-rearranged NSCLC. (3) To determine the overall survival of AUY922 in patients with stage IV EGFR T790M, EGFR exon 20 and other uncommon, HER2, KRAS, or BRAF-mutated; ALK, ROS1, or RET-rearranged NSCLC. Exploratory Objective(s): To study the pharmacodynamics of circulating tumor cells and plasma proteins. Planned number of subjects: A total of 63 patients for the first stage of this study in 1 - 3 centers in Taiwan. Patient population: 1. Stage IV (by AJCC 7th edition) NSCLC. 2. EGFR T790M mutation; EGFR exon 20 and other uncommon mutation; HER2 mutation; BRAF mutation; ALK translocation; ROS1 translocation; or RET translocation in tumor samples. 3. One line of prior systemic therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
31
AUY922 will be administered via IV over 1 hour once weekly in a 21 day cycle until disease progression
National Cheng Kung University Hospital
Tainan, Taiwan
Department of Oncology, National Taiwan University Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Objective response rate
To define the by RECIST 1.1 of AUY922 in patients with stage IV EGFR T790M, EGFR exon 20 and other uncommon, HER2, or BRAF-mutated; ALK, ROS1, or RET-rearranged NSCLC
Time frame: Patients will be followed up for 2 years(post disease progression)
Efficacy, progression-free survival (PFS)
Patients will be followed for progression-free survival (PFS) and overall survival (OS) which will be analyzed by using a Kaplan-Meier curve. Patients will be followed up for PFS and OS for 2 years.
Time frame: Patients will be followed up for PFS and OS for 2 years.(post disease progression)
overall survival (OS)
Patients will be followed for overall survival (OS)
Time frame: Patients will be followed up for OS for 2 years.(post disease progression)
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