Crizotinib Plus Pembrolizumab In Alk-Positive Advanced Non Small Cell Lung Cancer Patients
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.
Checked against the public recordLast updated Jul 1, 2019 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Pfizer
- Interventions being studied
- Drug: Crizotinib; Drug: Pembrolizumab
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
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.