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TerminatedPhase 1NCT02511184
Official study title

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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedCrizotinib and Pembrolizumab

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · ALK

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jul 1, 2019 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?15 U.S. locations

Locations may change over time.

Who runs it?Pfizer

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Pfizer
Interventions being studied
Drug: Crizotinib; Drug: Pembrolizumab
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Biomarkers
ALK→
Treatment approach
Immunotherapy→Targeted therapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.
Reasons someone may not be able to joinExclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • University of Alabama at BirminghamBirmingham, Alabama
  • University of Alabama at Birmingham, IDS PharmacyBirmingham, Alabama
  • University of Alabama at BirminghamBirmingham, Alabama
  • City of Hope National Medical CenterDuarte, California
  • UC San Diego Moores Cancer Center - Investigational Drug ServicesLa Jolla, California
  • UC San Diego Medical Center - La Jolla(Thornton Hospital)La Jolla, California
  • University Of California / San Diego Moores Cancer CenterLa Jolla, California
  • UC San Diego Medical Center - HillcrestSan Diego, California
  • Emory University Hospital MidtownAtlanta, Georgia
  • Emory University HospitalAtlanta, Georgia
  • The Emory ClinicAtlanta, Georgia
  • Winship Cancer Institute of Emory UniversityAtlanta, Georgia

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 1, 2019. Always confirm current availability with the study team.

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