Clinical trial NCT02393625: 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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: ALK-positive NSCLC
Keywords: NSCLC, ALK-positive
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2015-03-19
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Maximum Tolerated Dose (MTD) and/or Recommended Dose for Expansion
timeFrame: Study Day 42 (6 weeks)
measure: Overall response rate (ORR)
timeFrame: 24 Weeks
Secondary outcomes:
measure: Duration of Response (DOR)
timeFrame: 24 weeks
measure: Disease Control Rate (DCR)
timeFrame: 24 weeks
measure: Time to Response (TTR)
timeFrame: 24 weeks
measure: Progression Free Survival (PFS)
timeFrame: 24 weeks
measure: Overall survival (OS)
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic - Arizona
state: Arizona
city: Boston
country: United States
facility: Massachusetts General Hospital Thoracic Oncolgoy
state: Massachusetts
city: Philadelphia
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Heidelberg
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Leuven
country: Belgium
facility: Novartis Investigative Site
city: Toronto
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Hong Kong
country: Hong Kong
facility: Novartis Investigative Site
city: Milano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Modena
country: Italy
facility: Novartis Investigative Site
state: MO
city: Singapore
country: Singapore
facility: Novartis Investigative Site
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Spigel DR, Reynolds C, Waterhouse D, Garon EB, Chandler J, Babu S, Thurmes P, Spira A, Jotte R, Zhu J, Lin WH, Blumenschein G Jr. Phase 1/2 Study of the Safety and Tolerability of Nivolumab Plus Crizotinib for the First-Line Treatment of Anaplastic Lymphoma Kinase Translocation - Positive Advanced Non-Small Cell Lung Cancer (CheckMate 370). J Thorac Oncol. 2018 May;13(5):682-688. doi: 10.1016/j.jtho.2018.02.022. Epub 2018 Mar 6.