NCT01922583

AUY922 in Patient With Stage IV NSCLC

A Multi-center Phase II Study of AUY922 in Patients With Stage IV Non-small Cell Lung Cancer (NSCLC) With Driver Molecular Alterations Other Than Sensitive EGFR Mutation, Who Have Progressed After One Line of Systemic Therapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Non-small Cell Lung Cancer (NSCLC)

Interventions

Type	Name	Description
DRUG	AUY922	AUY922 will be administered via IV over 1 hour once weekly in a 21 day cycle until disease progression

Timeline

• Start date: 2014-01-01
• Primary completion: 2017-02-01
• Completion: 2017-02-01
• First posted: 2013-08-14
• Last updated: 2018-07-18

Locations

3 sites across 1 country: Taiwan