Crizotinib Plus Pembrolizumab In Alk-Positive Advanced Non Small Cell Lung Cancer Patients

The patients will be screened for up to 28 days before they start treatment to determine

if they meet eligibility criteria. The screening procedures will include physical

examination, blood work and radiological scans.

In the dose finding phase, patients who meet eligibility criteria will receive crizotinib

at the dose level assigned that will be taken on daily basis and pembrolizumab 200 mg

intravenous infusion every 3 weeks.

Once a Crizotinib dose level is decided, the dose expansion cohort will start enrolling

patients who meet eligibility criteria.

All patients will be followed up every three weeks. Blood samples will be drawn to test

for safety and tumor activities and radiological scans will be performed on certain

timepoints to determine the antitumor activities.

There will be a quality of life questionnaire administered at certain time points during

the study.

The study will have a quality assurance plan that addresses data validation and registry

procedures. There is a plan to visit the investigator site for routine monitoring and

auditing.

The team will conduct source data verification to assess the accuracy, completeness, or

representativeness of registry data by comparing the data to external data sources (e.g.,

medical records, paper or electronic case report forms, or interactive voice response

systems).

The study will also include a statistical analysis plan describing the analytical

principles and statistical techniques to be employed in order to address the primary and

secondary objectives of this study, as specified in the study protocol or statistical

plan.