Brief Title
LDK378 in Patients With ALK Positive NSCLC Previously Treated With Alectinib.
Official Title
A Phase II, Multi-center, Open-label, Single-Arm Study to Evaluate the Efficacy and Safety of Oral LDK378 Treatment for Patients With ALK-Positive Non-Small Cell Lung Cancer Previously Treated With Alectinib
Brief Summary
This is a single-arm, open-label, multicenter, phase II study to evaluate the efficacy and
safety of the ALK inhibitor LDK378 when used as single agent in patients with ALK-rearranged
stage IIIB or IV NSCLC previously treated with alectinib. Treatment with LDK378 750 mg qd
will continue until the patient experiences disease progression as determined by the
investigator according to RECIST 1.1, unacceptable toxicity that precludes further treatment,
pregnancy, start of a new anticancer therapy, discontinues treatment at the discretion of the
patient or investigator, lost to follow-up, death, or study is terminated by Sponsor.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Overall response rate (ORR) to LDK378 by investigator assessment
Secondary Outcome
Disease control rate (DCR)
Condition
Non-Small-Cell Lung Cancer
Intervention
LDK378
Study Arms / Comparison Groups
LDK378
Description: Oral LDK378 750mg once daily
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
20
Start Date
August 21, 2015
Completion Date
May 24, 2018
Primary Completion Date
July 31, 2017
Eligibility Criteria
Inclusion Criteria:
- Histologically or cytologically confirmed diagnosis of Stage IIIb or IV NSCLC that
carries an ALK rearrangement as determined locally by Vysis ALK Break Apart FISH Probe
Kit (Abbott Molecular Inc.) test.
- Patients must have NSCLC that has progressed at study enrollment.
- Patients must have received previous treatment with alectinib for treatment of locally
advanced or metastatic NSCLC. Prior therapy with crizotinib as ALK inhibitor therapy
in addition to alectinib is allowed. Alectinib doesn't need to be the last therapy
prior to study enrollment. No particular sequence of prior alectinib and crizotinib is
required for enrollment.
- Patients must be chemotherapy-naïve or have received only one line of prior cytotoxic
chemotherapy.
- Age 18 years or older at the time of informed consent.
Exclusion Criteria:
- Patients with known hypersensitivity to any of the excipients of LDK378.
- Prior therapy with other ALK inhibitor investigational agents except crizotinib and
alectinib.
- Prior systemic anti-cancer (including investigational) therapy aside from alectinib,
crizotinib and one regimen of previous cytotoxic chemotherapy for locally advanced or
metastatic NSCLC.
- Patients with symptomatic central nervous system (CNS) metastases who are
neurologically unstable or have required increasing doses of steroids within the 2
weeks prior to study entry to manage CNS symptoms.
- Patient with history of interstitial lung disease or interstitial pneumonitis,
including clinically significant radiation pneumonitis.
- Ptients with history of carcinomatous meningitis.
- Patient with a concurrent malignancy or history of a malignant disease other than
NSCLC that has been diagnosed and/or required therapy within the past 3 years.
- Patient has clinically significant, uncontrolled heart disease and/or recent cardiac
event (within 6 months)
Other protocol-defined inclusion/exclusion criteria may apply
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Novartis Pharmaceuticals, ,
Location Countries
Japan
Location Countries
Japan
Administrative Informations
NCT ID
NCT02450903
Organization ID
CLDK378A1201
Responsible Party
Sponsor
Study Sponsor
Novartis Pharmaceuticals
Study Sponsor
Novartis Pharmaceuticals, Study Director, Novartis Pharmaceuticals
Verification Date
January 2019