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

Description

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

Interventions

  • Drug: Ceritinib (LDK378)
  • Drug: Nivolumab

Specialties

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

MeSH Terms

  • Carcinoma
  • Non-Small-Cell Lung

Study ID

Novartis -- CLDK378A2120C

Status

Unknown

Trial ID

NCT02393625

Study Type

Interventional

Trial Phase

Phase 1

Enrollment Quota

78

Sponsor

Novartis

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

No

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

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