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
Title
- Brief Title: Study of Safety and Efficacy of Ceritinib in Combination With Nivolumab in Patients With ALK-positive Non-small Cell Lung Cancer
- Official 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)
Clinical Trial IDs
- ORG STUDY ID:
CLDK378A2120C
- NCT ID:
NCT02393625
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Ceritinib (LDK378) | | Dose Escalation |
Nivolumab | | Dose Escalation |
Purpose
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
Trial Arms
Name | Type | Description | Interventions |
---|
Dose Escalation | Experimental | | - Ceritinib (LDK378)
- Nivolumab
|
Dose Expansion | Experimental | | - Ceritinib (LDK378)
- Nivolumab
|
Eligibility 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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Maximum Tolerated Dose (MTD) and/or Recommended Dose for Expansion |
Time Frame: | Study Day 42 (6 weeks) |
Safety Issue: | |
Description: | ORR (complete response (CR)+ partial response (PR)) per RECIST 1.1 as assessed by investigator |
Secondary Outcome Measures
Measure: | Duration of Response (DOR) |
Time Frame: | 24 weeks |
Safety Issue: | |
Description: | |
Measure: | Disease Control Rate (DCR) |
Time Frame: | 24 weeks |
Safety Issue: | |
Description: | |
Measure: | Time to Response (TTR) |
Time Frame: | 24 weeks |
Safety Issue: | |
Description: | |
Measure: | Progression Free Survival (PFS) |
Time Frame: | 24 weeks |
Safety Issue: | |
Description: | |
Measure: | Overall survival (OS) |
Time Frame: | 24 weeks |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Novartis Pharmaceuticals |
Trial Keywords
Last Updated
June 23, 2021