Study of Safety and Efficacy of Ceritinib in Combination With Nivolumab in Patients With ALK-positive Non-small Cell Lung Cancer

Novartis

Status and phase

Active, not recruiting

Phase 1

Conditions

ALK-positive NSCLC

Treatments

Drug: Ceritinib (LDK378)

Drug: Nivolumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT02393625

CLDK378A2120C

2024-510824-38-00 (Registry Identifier)

Details and patient eligibility

About

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

Enrollment

57 patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

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