An Open-label, Randomized Phase II Study to Evaluate the Efficacy of AUY922 vs Pemetrexed or Docetaxel in NSCLC Patients With EGFR Mutations

The primary purpose of this study is to compare the efficacy of AUY922, when administered
i.v. on a once-weekly schedule at 70 mg/m2, versus docetaxel or pemetrexed in adult patients
with advanced NSCLC, whose tumors harbor EGFR activating mutations, and have developed
resistance to EGFR TKI.

Inclusion Criteria:

1. Patients with histologically or cytologically documented, locally advanced (stage
IIIB who are not amenable to combined modality treatment) or recurrent or metastatic
(Stage IV) non-small cell lung cancer.

2. Patients must have EGFR gene mutation in their tumors. This can be source -
documented by one of the following:

• Provide a pathology report that indicates the patient's tumor had EGFR activating
mutation in the past.

Or:

• Perform testing (local or central) in an archival tumor or a fresh baseline biopsy
tumor tissue to show the presence of EGFR activating mutation.

3. Patients must have documented clinical benefit (CR, PR, or patients with SD for 6
months or greater) on prior EGFR TKI (e.g. erlotinib or gefitinib) followed by
documented progression according to RECIST.

4. Patients must have received prior platinum containing treatment.

5. WHO performance status of 0-1

Exclusion Criteria:

1. Patients who have received more than two prior lines of antineoplastic therapy for
advanced disease. Chemotherapy administered as neoadjuvant or adjuvant treatment more
than six months prior to study enrollment is not considered a prior line of therapy
for purposes of this study.

2. Evidence of spinal cord compression or current evidence of CNS metastases. Screening
CT/MRI of the brain is mandatory. Note: Patients who have been treated for CNS
metastases by radiation or gamma knife surgery, who been stable for at least 2 months
and have discontinued high dose corticosteroids will be eligible for protocol
participation

3. Prior treatment with an HSP90 inhibitor

Other protocol-defined inclusion/exclusion criteria may apply