Trial Information

Phase II Study of AUY922 in NSCLC Patients With Exon 20 Insertion Mutations in EGFR

Interested patients will be asked to undergo some screening tests and procedures to confirm
that they are eligible. Many of these tests and procedures are likely to be part of regular
cancer care and may be done even if it turns out that patients do not take part in the
research study. If patients have had some of these tests or procedures recently, they may or
may not have to be repeated. These tests and procedures include: a medical history physical
exam, performance status, assessment of tumor, EKG, electrocardiogram or multigated
acquisition scan, eye exam, blood draw, blood pregnancy test, urine test and collection of a
piece of the stored tumor tissue.

The study treatment is given in 21 day cycles. AUY922 is given by IV (into a vein). This is
called an infusion. Patients will receive an infusion of AUY922 on days 1, 8 and 15 of each
cycle (once per week). The infusion will take about 60 minutes.

A schedule of clinic visits for the study is summarized below.

Cycle 1, Day 1: physical exam, including measurement of vital signs and weight; performance
status; EKG; blood draw; routine urine test Cycle 1, Day 2: EKG Cycle 1, Day 3: EKG Cycle 1,
Day 8: Vital signs, performance status, EKG, questions about side effects and other
medications taken Cycle 1, Day 15: Physical exam, including measurement of vital signs,
performance status; EKG; blood draw; questions about side effects and other medications
taken Note that in Cycle 1 patients will need to stay at (or return to) the clinic for the
last EKG following the Day 1 AUY922 infusion, and come to the clinic on Days 2 and 3 for
EKGs.

Cycle 2 and beyond, Day 1: physical exam, including measurement of vital signs and weight;
performance status; EKG; blood draw; questions about side effects and other medications
taken; routine urine test Cycle 2 and beyond, Day 8: Vital signs; performance status; EKG;
questions about side effects and other medications taken Cycle 2 and beyond, Day 15:
Physical exam, including measurement of vital signs; performance status; EKG; blood draw;
questions about side effects and other medications taken.

Additional EKGs may be done at any time if the study doctor thinks it is necessary. A blood
test to measure the amount of cardiac enzymes in the blood may be done whenever abnormal
findings are suspected or seen on the EKG.

Additional tests and procedures:

- CT or MRI scans will be done to measure the disease about every 6 weeks.

- A blood pregnancy test, for women who can become pregnant, will be performed every 6
weeks or at any point in which pregnancy is suspected.

- A standard eye exam will be done on Cycle 3, Day 1. Additional eye exams will be done
if patients experience any eye-related symptoms, such as changes in vision.

Within 1 week after the last dose of the study drug AUY922, patients will be asked to return
to the clinic. At this visit the following will be done: physical examination, performance
status, EKG, ECHO or MUGA scan, blood draw, urine test, eye exam, questions about side
effects and other medications taken. Patients will be asked to return to the clinic a second
time so investigators can follow-up on any ongoing side effects after stopping AUY922.