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Clinical Trials in Australia / NCT02393625
Active, not recruiting Phase 1

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

NCT02393625 · tracked via the Priya Life Science Australia tracker
Phase
Phase 1
Started
2015-05-27
Last updated
2026-09-17

Condition(s) studied

ALK-positive NSCLC

Investigational drug(s) / intervention(s)

Ceritinib (LDK378) →Nivolumab →

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (12)

FacilityCityRegionStatus
Mayo Clinic - Arizona Scottsdale Arizona
Massachusetts General Hospital Boston Massachusetts
Massachusetts General Hospital Thoracic Oncolgoy Boston Massachusetts
Fox Chase Cancer Center Philadelphia Pennsylvania
Novartis Investigative Site Heidelberg Victoria
Novartis Investigative Site Leuven Vlaams Brabant
Novartis Investigative Site Toronto Ontario
Novartis Investigative Site Hong Kong Hong Kong
Novartis Investigative Site Milan MI
Novartis Investigative Site Modena MO
Novartis Investigative Site Singapore Singapore
Novartis Investigative Site Barcelona Spain

On this site

📄 Opdivo (nivolumab) drug profile →

More Novartis Pharmaceuticals trials in Australia

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02393625 on ClinicalTrials.gov ↗ ← All trials in Australia