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

• Status: Terminated
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Crizotinib; Pembrolizumab

Criteria

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.