A Study of the Safety and Effectiveness of Ceritinib Combined with Nivolumab for Patients with ALK-Positive Non-Small Cell Lung Cancer

Overview

About this study

The purpose of this study is to determine the safety and effectiveness of ceritinib when combined with nivolumab for anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer patients.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

Inclusion Criteria

  • Histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC) that carries an anaplastic lymphoma kinase(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. 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

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Helen Ross, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20206574

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