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

• Register: ClinicalTrials.gov
• Last refreshed on: 29 May 2023
• Main ID: NCT02393625
• Date of registration: 23/02/2015
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharmaceuticals
• Public title: Study of Safety and Efficacy of Ceritinib in Combination With Nivolumab in Patients With ALK-positive Non-small Cell Lung Cancer
• Scientific title: 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)
• Date of first enrolment: May 27, 2015
• Target sample size: 57
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT02393625
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

Australia, Austria, Belgium, Canada, Hong Kong, Italy, Netherlands, Singapore, Spain, United States

Contacts

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

ALK-positive NSCLC

Intervention(s)

Drug: Nivolumab

Drug: Ceritinib (LDK378)

Primary Outcome(s)

Maximum Tolerated Dose (MTD) and/or Recommended Dose for Expansion [Time Frame: Study Day 42 (6 weeks)]

Overall response rate (ORR) [Time Frame: 24 Weeks]

Secondary Outcome(s)

Progression Free Survival (PFS) [Time Frame: 24 weeks]

Duration of Response (DOR) [Time Frame: 24 weeks]

Overall survival (OS) [Time Frame: 24 weeks]

Time to Response (TTR) [Time Frame: 24 weeks]

Disease Control Rate (DCR) [Time Frame: 24 weeks]

Secondary ID(s)

2014-005054-19

CLDK378A2120C

Source(s) of Monetary Support

Please refer to primary and secondary sponsors