Ignite Creation Date:
2024-05-06 @ 7:19 AM
Last Modification Date:
2024-10-26 @ 11:47 AM
Study NCT ID:
NCT02511184
Status:
TERMINATED
Last Update Posted:
2019-07-01
First Post:
2015-07-22
Brief Title:
Crizotinib Plus Pembrolizumab In Alk-Positive Advanced Non Small Cell Lung Cancer Patients
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
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
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Decision based on the low enrollment mainly due to high efficacy drugs available in 1st line ALK-positive NSCLC eg alectinib not due to any safety concerns
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 eg 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
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 eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CRIZOTINIB | OTHER | Alias Study Number | None |
| KEYNOTE 050 | OTHER | None | None |