Phase 2 Study of AUY922 in NSCLC Patients With Exon 20 Insertion Mutations in EGFR
Status:
Completed
Trial end date:
2017-03-01
Target enrollment:
Participant gender:
Summary
This research study is a Phase II clinical trial, which tests the safety and effectiveness of
an investigational drug to learn whether the drug works in treating a specific cancer.
"Investigational" means that the drug is being studied. It also means that the FDA has not
yet approved the drug for your type of cancer or for any use outside of research studies.
It has been found that some people with NSCLC have a change (mutation) in a certain gene
called the EGFR gene. This mutated gene helps cancer cells grow. The majority of NSCLC
patients with EGFR mutations achieve good outcomes with erlotinib or other EGFR inhibitor
therapies, with a high response rate, prolonged progression-free survival and possibly
improved overall survival from therapy. However, the 4% of EGFR mutant patients that harbor
an exon 20 insertion mutation historically have reaped little benefit from EGFR-directed
therapy due to the low affinity of this mutation for direct EGFR inhibitors, especially
erlotinib and gefitinib (see Yasuda et al, Lancet Oncol 2011). This group of patients is
ideal for studying other targeted therapeutic strategies that could affect the oncogene
mutation in EGFR via alternative mechanisms.
AUY922 is an investigational drug that may stop cancer cells from growing abnormally. This
drug has been used in other research studies. Information from those other research studies
suggests that AUY922 may be effective in killing cancer cells in patients with exon 20
insertion mutations in EGFR.
The purpose of this study is to test the safety of AUY922 and determine how well AUY922 works
for participants with advanced NSCLC and exon 20 insertion mutations in EGFR.