A Multi-center, Open-label Study to Assess the Safety and Efficacy of Combination Ceritinib (LDK378) and Nivolumab in Adult Patients With Anaplastic Lymphoma Kinase (ALK)-Positive Non-small Cell Lung Cancer (NSCLC)

Novartis Pharmaceuticals14 sites in 8 countries57 target enrollmentMay 27, 2015

ConditionsALK-positive NSCLC

InterventionsNivolumab Ceritinib (LDK378)

DrugsCeritinib (LDK378)Nivolumab

Overview

Phase: Phase 1
Intervention: Nivolumab
Conditions: ALK-positive NSCLC
Sponsor: Novartis Pharmaceuticals
Enrollment: 57
Locations: 14
Primary Endpoint: Maximum Tolerated Dose (MTD) and/or Recommended Dose for Expansion
Status: Active, not recruiting
Last Updated: 2 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is an open label multi center trial to determine the safety and efficacy of ceritinib in combination with nivolumab in ALK-positive NSCLC patients

Registry

clinicaltrials.gov

Start Date

May 27, 2015

End Date

April 9, 2027

Last Updated

2 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Novartis Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Histologically or cytologically confirmed diagnosis of NSCLC that carries an ALK rearrangement
•Stage IIIB or IV NSCLC or relapsed locally advanced or metastatic NSCLC
•Presence of at least one measurable lesion as defined by RECIST 1.1
•Patients who have received prior chemotherapy, other ALK inhibitors, biologic therapy, or other investigational agents, must have recovered from all toxicities related to prior anticancer therapies to grade ≤1 (CTCAE v 4.03). Patients with grade ≤ 2 peripheral neuropathy or any grade of alopecia, fatigue, nail changes or skin changes are allowed to enter the study
•Patient has a WHO performance status 0-1

Exclusion Criteria

•Presence or history of a malignant disease other than NSCLC that has been diagnosed and/or required therapy within the past 3 years
•Patients with an active, known or suspected autoimmune disease
•Unable or unwilling to swallow tablets or capsules
•Patient has other severe, acute, or chronic medical conditions including uncontrolled diabetes mellitus or psychiatric conditions or laboratory abnormalities that in the opinion of the Investigator may increase the risk associated with study participation, or that may interfere with the interpretation of study results