ALK-positive Advanced NSCLC Clinical Trial
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
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.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
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A Study of Brigatinib in Participants With Anaplastic Lymphoma Kinase-Positive (ALK+), Advanced Non-Small-Cell Lung Cancer (NSCLC) Progressed on Alectinib or Ceritinib
|
Phase 2 | |
| Completed |
NCT03410108 -
Phase 2 Study of Brigatinib in Japanese Participants With Anaplastic Lymphoma Kinase (ALK)-Positive Non-Small Cell Lung Cancer (NSCLC)
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Phase 2 |