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



Status:Recruiting
Conditions:Lung Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/22/2019
Start Date:May 27, 2015
End Date:May 26, 2020
Contact:Novartis Pharmaceuticals
Email:novartis.email@novartis.com
Phone:1-888-669-6682

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A Multi-center, Open-label Study to Assess the Safety and Efficacy of Combination Ceritinib (LDK378) and Nivolumab in Adult Patients With Anaplastic Lymphoma Kinase (ALK)-Positive Non-small Cell Lung Cancer (NSCLC)

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


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
We found this trial at
4
sites
13400 E. Shea Blvd.
Scottsdale, Arizona 85259
480-301-8000
Principal Investigator: Helen Ross
Phone: 855-776-0015
Mayo Clinic Arizona Mayo Clinic in Arizona provides medical care for thousands of people from...
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Boston, Massachusetts 02114
Principal Investigator: Alice Shaw
Phone: 617-724-4000
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Boston, MA
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Heidelberg, Victoria 3084
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Heidelberg,
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Philadelphia, Pennsylvania 19111
Principal Investigator: Jessica Bauman
Phone: 215-214-1676
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Philadelphia, PA
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