Boston, Massachusetts 02115


Purpose:

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


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


NCT ID:

NCT02393625


Primary Contact:

Study Director
Novartis Pharmaceuticals
Novartis Pharmaceuticals

Novartis Pharmaceuticals
Phone: 1-888-669-6682
Email: novartis.email@novartis.com


Backup Contact:

Email: novartis.email@novartis.com
Novartis Pharmaceuticals
Phone: +41613241111


Location Contact:

Boston, Massachusetts 02115
United States

Alice Shaw, MD
Phone: 617-724-4000

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: October 18, 2018

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