Study Stopped
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
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
3 other identifiers
interventional
9
1 country
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Oct 2015
Typical duration for phase_1
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 22, 2015
CompletedFirst Posted
Study publicly available on registry
July 29, 2015
CompletedStudy Start
First participant enrolled
October 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedResults Posted
Study results publicly available
July 1, 2019
CompletedJuly 1, 2019
April 1, 2019
2.2 years
July 22, 2015
December 4, 2018
April 4, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Dose-limiting Toxicity (DLT)
Dose-limiting toxicity (DLT) was defined as any of the following adverse events (AEs) occurring in the first 2 cycles of treatment (6 weeks) which were attributable to crizotinib, pembrolizumab or both: hematologic toxicities including Grade 4 neutropenia, febrile neutropenia, Grade greater than or equal to (\>=) 3 neutropenic infection, Grade \>=3 thrombocytopenia with bleeding; Grade 4 thrombocytopenia; non-hematologic toxicities including Grade \>=3 toxicities (non-laboratory), Grade \>=3 nausea, vomiting, or diarrhea despite maximal therapy, non-hematologic Grade \>=3 laboratory value if medical intervention was required to treat the participant or the abnormality led to hospitalization; inability to complete at least 80 percent of the first 2-cycle doses of crizotinib or both infusions of pembrolizumab within the DLT observation period due to treatment-related toxicity. Grade was based on National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) version 4.03.
6 weeks
Secondary Outcomes (32)
Number of Participants With Treatment-Emergent Adverse Events
2 years
Objective Response Rate (ORR)
Baseline, Week 9 and every 6 weeks thereafter, for about 2 years
Duration of Response
Baseline, Week 9 and every 6 weeks thereafter, for about 2 years
Time to Tumor Response
Baseline, Week 9 and every 6 weeks thereafter, for about 2 years
Progression Free Survival
Baseline, Week 9 and every 6 weeks thereafter, for about 2 years
- +27 more secondary outcomes
Study Arms (1)
Dose finding and dose expansion phases
EXPERIMENTALFind and expand the maximum tolerated dose of crizotinib in combination with pembrolizumab 200 mg iv infusion every 3 weeks.
Interventions
To test 3 dose levels of crizotinib in combination with pembrolizumab 200 mg iv infusion every 3 weeks
To test pembrolizumab at 200 mg every 3 weeks in combination with crizotinib at 3 dose levels.
Eligibility Criteria
You may qualify if:
- Histologically or cytologically proved diagnosis of locally advanced recurrent or metastatic non-squamous NSCLC that is not suitable for local curative treatment.
- Alk-positive NSCLC as determined by a test that is approved or validated for use as a companion diagnostic test.
- No prior systemic therapy for metastatic disease.
- Adjuvant chemotherapy more than 12 months prior to study enrollment.
- Measurable disease as per RECIST 1.1
- ECOG PS 0 or 1.
You may not qualify if:
- Prior exposure to ALK receptor tyrosine kinase inhibitor, anti-PD1, anti-PDL1 or any drug targeting T-cell checkpoint pathways.
- known diagnosis of immunodeficiency or is receiving systemic steroid therapy or other form of immunosuppressive therapy within 7 days of clinical trial treatment.
- Active autoimmune disease that has required systemic treatment in the past 3 months.
- History of extensive disseminated interstitial fibrosis or any grade of interstitial lung disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (15)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
University of Alabama at Birmingham, IDS Pharmacy
Birmingham, Alabama, 35249, United States
University of Alabama at Birmingham
Birmingham, Alabama, 35249, United States
City of Hope National Medical Center
Duarte, California, 91010, United States
UC San Diego Moores Cancer Center - Investigational Drug Services
La Jolla, California, 92037-0845, United States
UC San Diego Medical Center - La Jolla(Thornton Hospital)
La Jolla, California, 92037, United States
University Of California / San Diego Moores Cancer Center
La Jolla, California, 92093, United States
UC San Diego Medical Center - Hillcrest
San Diego, California, 92103, United States
Emory University Hospital Midtown
Atlanta, Georgia, 30308, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
The Emory Clinic
Atlanta, Georgia, 30322, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Swedish Cancer Institute
Seattle, Washington, 98104, United States
Swedish Investigational Drug Services Pharmacy
Seattle, Washington, 98104, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Some of the pre-defined outcome measures could not be analyzed because of premature termination, which was based on low enrollment rate.
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Masking
- NONE
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 22, 2015
First Posted
July 29, 2015
Study Start
October 1, 2015
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
July 1, 2019
Results First Posted
July 1, 2019
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will not share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.