LDK378 in Patients With ALK Positive NSCLC Previously Treated With Alectinib.

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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