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

Running, not enrolling · Phase 1

Conditions studied: ALK-positive NSCLC

In brief

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

Key facts

Study ID

NCT02393625

Run by

Novartis Pharmaceuticals

People needed

57

Starts

2015-05-27

Expected to finish

2027-04-09

Last updated by the study team

2026-06-11

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Mayo Clinic - Arizona — Scottsdale, Arizona, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Massachusetts General Hospital Thoracic Oncolgoy — Boston, Massachusetts, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
• Novartis Investigative Site — Heidelberg, Victoria, Australia
• Novartis Investigative Site — Leuven, Vlaams Brabant, Belgium
• Novartis Investigative Site — Toronto, Ontario, Canada
• Novartis Investigative Site — Hong Kong, Hong Kong
• Novartis Investigative Site — Milan, MI, Italy
• Novartis Investigative Site — Modena, MO, Italy
• Novartis Investigative Site — Singapore, Singapore
• Novartis Investigative Site — Barcelona, Spain

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.