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

Study Overview
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Brief Summary
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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

Official Title
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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)

Conditions
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ALK-positive NSCLC

Intervention / Treatment
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* Drug: Ceritinib (LDK378)
* Drug: Nivolumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose Escalation<br> | Drug: Ceritinib (LDK378)<br> <br> Drug: Nivolumab<br> <br> |
| Experimental: Dose Expansion<br> | Drug: Ceritinib (LDK378)<br> <br> Drug: Nivolumab<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Tolerated Dose (MTD) and/or Recommended Dose for Expansion |  | Study Day 42 (6 weeks) | 
| Overall response rate (ORR) | ORR (complete response (CR)+ partial response (PR)) per RECIST 1.1 as assessed by investigator | 24 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Response (DOR) |  | 24 weeks | 
| Disease Control Rate (DCR) |  | 24 weeks | 
| Time to Response (TTR) |  | 24 weeks | 
| Progression Free Survival (PFS) |  | 24 weeks | 
| Overall survival (OS) |  | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NSCLC, ALK-positive