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About
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.
Full 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:
Enrollment
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Volunteers
Inclusion criteria
Histologically or cytologically proven diagnosis of stage IV NSCLC (AJCC 7th) which had been treated with one systemic therapy.
One of the molecular alterations as follows:
Patients with brain metastases are eligible if treated and neurologically stable for at least 2 weeks and is not taking any steroid.
Any prior chemotherapy, targeted therapy (monoclonal antibodies), or major surgeries must have had completed at least 4 weeks before initiation of study medication. Any prior targeted therapy (tyrosine kinase inhibitors), radiotherapy or minor surgeries must have had completed at least 2 weeks before initiation of study medication. Any acute toxicity must have recovered to <=grade 1 (except for alopecia).
Patients must have measurable or evaluable disease as per RECIST version 1.1.
20 years of age or older
ECOG performance status 0-2
Adequate organ function as defined by the following criteria:
Able to communicate well with the investigator, to understand and comply with the requirements of the study. Understand and sign the written informed consent.
Patients must use effective methods of contraception during the study period and for at least 90 days following study completion (excluding surgically sterile male patients, surgically sterile or postmenopausal female patients).
Exclusion criteria
Currently on other therapeutic clinical trials
Prior treatment of HSP90 inhibitors
Any of the following within 3 months before initiation of study medication
Ongoing cardiac arrhythmias of NCI CTCAE grade >=2
Active infection requiring antibiotics
Pregnancy or breast feeding
Prior malignancy within the past 5 years (excluding non-melanoma skin cancer, cervical carcinoma in situ, superficial bladder cancer, and early prostate cancer).
Active hepatitis B or C; positive HIV test result.
Primary purpose
Allocation
Interventional model
Masking
31 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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