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

ALK-positive NSCLC Clinical Trial

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 Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02393625
• Other study ID #: CLDK378A2120C
• Secondary ID: 2014-005054-19
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: May 27, 2015
• Est. completion date: April 10, 2025

Study information

• Verified date: June 2024
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 57
• Est. completion date: April 10, 2025
• Est. primary completion date: April 10, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• ALK-positive NSCLC
• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• Ceritinib (LDK378)

• Nivolumab

Locations

Country	Name	City	State
Australia	Novartis Investigative Site	Heidelberg	Victoria
Belgium	Novartis Investigative Site	Leuven
Canada	Novartis Investigative Site	Toronto	Ontario
Hong Kong	Novartis Investigative Site	Hong Kong
Italy	Novartis Investigative Site	Milano	MI
Italy	Novartis Investigative Site	Modena	MO
Singapore	Novartis Investigative Site	Singapore
Spain	Novartis Investigative Site	Barcelona	Catalunya
United States	Massachusetts General Hospital Thoracic Oncolgoy	Boston	Massachusetts
United States	Novartis Investigative Site	Philadelphia	Pennsylvania
United States	Mayo Clinic - Arizona	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Hong Kong,  Italy,  Singapore,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Tolerated Dose (MTD) and/or Recommended Dose for Expansion		Study Day 42 (6 weeks)
Primary	Overall response rate (ORR)	ORR (complete response (CR)+ partial response (PR)) per RECIST 1.1 as assessed by investigator	24 Weeks
Secondary	Duration of Response (DOR)		24 weeks
Secondary	Disease Control Rate (DCR)		24 weeks
Secondary	Time to Response (TTR)		24 weeks
Secondary	Progression Free Survival (PFS)		24 weeks
Secondary	Overall survival (OS)		24 weeks