ALK-positive NSCLC
Conditions
Keywords
NSCLC, ALK-positive
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
Interventions
DRUGNivolumab
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | 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 |
Countries
Australia, Belgium, Canada, Hong Kong, Italy, Singapore, Spain, United States
Contacts
STUDY_DIRECTORNovartis Pharmaceuticals
Novartis Pharmaceuticals
Outcome results
None listed