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

Last updated on March 28, 2018

FOR MORE INFORMATION
Study Location
University of Alabama at Birmingham
Birmingham, Alabama, 35233 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
ALK-positive Advanced NSCLC
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT02511184
Pfizer
Terminated
Crizotinib Plus Pembrolizumab In Alk-Positive Advanced Non Small Cell Lung Cancer Patients

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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
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.

Interventional
Phase 1
Masking: None (Open Label)
Primary Purpose: Treatment
ALK-positive Advanced NSCLC
  • 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.
Experimental: Dose finding and dose expansion phases
Find and expand the maximum tolerated dose of crizotinib in combination with pembrolizumab 200 mg iv infusion every 3 weeks.
Interventions:
  • Drug: Crizotinib
  • Drug: Pembrolizumab
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
70
October 7, 2019
October 7, 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
United States
 
 
NCT02511184
A8081054
KEYNOTE 050 ( Other Identifier: Merck Sharp & Dohme Corp )
CRIZOTINIB ( Other Identifier: Alias Study Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Merck Sharp & Dohme Corp.
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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