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

Stopped early · Phase 1

Conditions studied: ALK-positive Advanced NSCLC

In brief

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.

Key facts

Study ID

NCT02511184

Run by

Pfizer

People needed

9

Starts

2015-10-01

Expected to finish

2017-12-01

Last updated by the study team

2019-07-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• University of Alabama at Birmingham, IDS Pharmacy — Birmingham, Alabama, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States
• City of Hope National Medical Center — Duarte, California, United States
• UC San Diego Moores Cancer Center - Investigational Drug Services — La Jolla, California, United States
• UC San Diego Medical Center - La Jolla(Thornton Hospital) — La Jolla, California, United States
• University Of California / San Diego Moores Cancer Center — La Jolla, California, United States
• UC San Diego Medical Center - Hillcrest — San Diego, California, United States
• Emory University Hospital Midtown — Atlanta, Georgia, United States
• Emory University Hospital — Atlanta, Georgia, United States
• The Emory Clinic — Atlanta, Georgia, United States
• Winship Cancer Institute of Emory University — Atlanta, Georgia, United States
• The Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Swedish Cancer Institute — Seattle, Washington, United States
• Swedish Investigational Drug Services Pharmacy — Seattle, Washington, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.