NCT02511184

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

A PHASE 1B STUDY OF CRIZOTINIB IN COMBINATION WITH PEMBROLIZUMAB (MK-3475) IN PATIENTS WITH UNTREATED ADVANCED ALK-TRANSLOCATED NON SMALL CELL LUNG CANCER

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study has 2 phases, a Dose Finding Phase will determine the maximum tolerated dose . The Dose Expansion Phase will explore the safety, tolerability, and anti-tumor activity of the combination.

Detailed description

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.

Conditions

• ALK-positive Advanced NSCLC

Interventions

Type	Name	Description
DRUG	Crizotinib	To test 3 dose levels of crizotinib in combination with pembrolizumab 200 mg iv infusion every 3 weeks
DRUG	Pembrolizumab	To test pembrolizumab at 200 mg every 3 weeks in combination with crizotinib at 3 dose levels.

Timeline

• Start date: 2015-10-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2015-07-29
• Last updated: 2019-07-01
• Results posted: 2019-07-01

Locations

15 sites across 1 country: United States