Study of Safety and Efficacy of Ceritinib in Combination With Nivolumab in Patients With ALK-positive Non-small Cell Lung Cancer
Phase 1
Active, not recruiting
- Conditions
- ALK-positive NSCLC
- Interventions
- Registration Number
- NCT02393625
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 57
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dose Escalation Ceritinib (LDK378) - Dose Escalation Nivolumab - Dose Expansion Ceritinib (LDK378) - Dose Expansion Nivolumab -
- Primary Outcome Measures
Name Time Method Maximum Tolerated Dose (MTD) and/or Recommended Dose for Expansion Study Day 42 (6 weeks) Overall response rate (ORR) 24 Weeks ORR (complete response (CR)+ partial response (PR)) per RECIST 1.1 as assessed by investigator
- Secondary Outcome Measures
Name Time Method Time to Response (TTR) 24 weeks Progression Free Survival (PFS) 24 weeks Overall survival (OS) 24 weeks Duration of Response (DOR) 24 weeks Disease Control Rate (DCR) 24 weeks
Trial Locations
- Locations (3)
Novartis Investigative Site
🇪🇸Barcelona, Catalunya, Spain
Mayo Clinic - Arizona
🇺🇸Scottsdale, Arizona, United States
Massachusetts General Hospital Thoracic Oncolgoy
🇺🇸Boston, Massachusetts, United States