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


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

Study Start Date

May 2015

Estimated Completion Date

October 2017


  • Drug: Ceritinib (LDK378)
  • Drug: Nivolumab


  • Pulmonology: Lung/Thoracic Oncology
  • Oncology: Lung/Thoracic Oncology
  • Physician Assistant: Hematology/Oncology

MeSH Terms

  • Carcinoma
  • Non-Small-Cell Lung

Study ID

Novartis -- CLDK378A2120C



Trial ID


Study Type


Trial Phase

Phase 1

Enrollment Quota




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




18 Years and older

Accepts Healthy Volunteers


Study Locations and Contact Information (2)

Study Location Distance Name Phone Email
Massachusetts General Hospital Thoracic Oncolgoy - Boston, Massachusetts 2.6 miles Alice Shaw MD 617-724-4000 None
Mayo Clinic Arizona - Scottsdale, Arizona 2,280.6 miles Clinical Trials Office All Mayo Clinic Locations 855-776-0015 None provides clinical trial listings in an easy to view format. All clinical trial information is pulled directly from This website does not guarantee acceptance into any clinical trial, and is not responsible for adverse events that may be incurred from a clinical trial.