AN OPEN-LABEL, NON-RANDOMIZED, MULTICENTER PHASE I/II TRIAL OF RO5424802 GIVEN ORALLY TO NON - SMALL CELL LUNG CANCER PATIENTS WHO HAVE ALK MUTATION AND FAILED CRIZOTINIB TREATMENT

Inclusion Criteria:

- Adult patients, >/= 18 years of age

- Locally advanced or metastatic non-small cell lung cancer (stage IIIB or IV by AJCC
7th)

- Eastern Cooperative Oncology Group (ECOG) performance status 0-2

- Documented ALK rearrangement based on FDA approved test

- Prior treatment with crizotinib and progression according to RECIST v1.1 criteria
with the last dose of crizotinib within 60 days from enrolment; patients can either
be chemotherapy-naïve or have received at least one line of platinum-based
chemotherapy

- Adequate hematologic, hepatic and renal function

- Patients with brain or leptomeningeal metastases are allowed on study if the lesions
are asymptomatic without neurological signs and clinically stable for at least 2
weeks

- Measurable disease according to RECIST v1.1 prior to administration of study drug

Exclusion Criteria:

- Receipt of any other ALK inhibitors in addition to crizotinib

- Receipt of any prior cytotoxic chemotherapy for ALK-positive NSCLC within 4 weeks
prior to Day 1. Patients who received crizotinib or any other tyrosine kinase
inhibitors need to have a minimum 2-week washout period before the first dose

- Active uncontrolled infectious diseases requiring treatment

- NCI CTCAE (version 4.03) Grade 3 or higher toxicities due to prior therapy that have
not shown improvement and are considered to interfere with current study medication

- History of organ transplant

- Co-administration of anti-cancer therapies other than those administered in this
study

- Baseline QTc > 470 ms or baseline symptomatic bradycardia < 45 beats per minute

- Pregnant or breastfeeding women

- Known HIV positivity or AIDS-related illness

- History of significant drug-related allergy (such as anaphylaxis)

- Any clinically significant concomitant disease or condition that could interfere
with, or for which treatment might interfere with, the conduct of the study, or
absorption of oral medications, or that would, in the opinion of the principal
investigator, pose an unacceptable risk to the subject in the study