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LDK378 Versus Chemotherapy in ALK Rearranged (ALK Positive) Patients Previously Treated With Chemotherapy (Platinum Doublet) and Crizotinib

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ClinicalTrials.gov Identifier: NCT01828112
Recruitment Status : Completed
First Posted : April 10, 2013
Results First Posted : July 27, 2017
Last Update Posted : November 30, 2023
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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Brief Summary:
The primary purpose of the study was to compare the antitumor activity of LDK378 vs. chemotherapy in patients previously treated with chemotherapy (platinum doublet) and crizotinib. Patients in the chemotherapy arm were given the option to switch to LDK378 after confirmed progressive disease (PD), while also had the choice to continue with pemetrexed treatment.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Drug: Ceritinib Drug: pemetrexed Drug: docetaxel Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 231 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III, Multicenter, Randomized, Open-label Study of Oral LDK378 Versus Standard Chemotherapy in Adult Patients With ALK-rearranged (ALK-positive) Advanced Non-small Cell Lung Cancer Who Have Been Treated Previously With Chemotherapy (Platinum Doublet) and Crizotinib
Actual Study Start Date : June 28, 2013
Actual Primary Completion Date : January 26, 2016
Actual Study Completion Date : November 10, 2023

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Ceritinib
Patients in this arm received 750 mg of ceritinib.
 Drug: Ceritinib
Ceritinib is the investigational treatment and is referred to as the investigational study drug and was provided as 150 mg hard gelatin capsules for oral use. The dose was 750 mg once daily.
Active Comparator: Chemotherapy
Patients in this arm received chemotherapy of either pemetrexed or docetaxel as determined by BIRC.
 Drug: pemetrexed
Pemetrexed was one of the chemotherapy treatments. Pemetrexed, a reconstituted solution, was intravenously administered over 10 minutes at 500 mg/m2 every 21 days.

Drug: docetaxel
Docetaxel was one of the chemotherapy treatments. Docetaxel, a reconstituted solution, was intravenously administered over 1 hour, at 75 mg/m2 every 21 days.


Outcome Measures
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Primary Outcome Measures :
  1. Progression Free Survival (PFS) Blinded Independent Review Committee Per Blinded Independent Review Committee (BIRC) [ Time Frame: 'from the date of randomization to the date of first radiologically documented disease progression or death due to any cause up to approximately 24 months ]
    PFS is defined as the time from the date of randomization to the date of the first radiologically documented disease progression or death due to any cause.


Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Month 18 ]
    OS is defined as time from date of randomization to date of death due to any cause.

  2. Overall Response Rate (ORR) [ Time Frame: Month 18 ]
    ORR is defined as the proportion of patients with a best overall response defined as complete response (CR) or partial response (PR); (CR+PR)

  3. Duration of Response (DOR) [ Time Frame: Month 18 ]
    DOR is defined as the time from date of first documented CR or PR to date of first documented disease progression or death due to underlying cancer

  4. Disease Control Rate (DCR) [ Time Frame: Month 18 ]
    DCR is defined as the proportion of patients with best overall response of CR, PR, or stable disease (SD)

  5. Time to Response (TTR) [ Time Frame: Month 18 ]
    TTR is defined as the time from date of randomization to date of first documented response (CR or PR)

  6. Patient Reported Outcomes (PRO) [ Time Frame: Screening, followed by every 6 weeks until Month 18 after Month 18 every 9 weeks ]
  7. Time to Definitive Deterioration [ Time Frame: from the date of randomization to the date of event for disease related symptoms ]
  8. Overall Intracranial Response Rate (OIRR) [ Time Frame: Screening, followed by every 6 weeks until Month 18 after Month 18 every 9 weeks ]
    OIRR is defined as the ORR based on lesions in brain (target, nontarget lesions (and new lesions, if applicable) and calculated as the proportion of patients with a best overall confirmed response of CR or PR in the brain per modified RECIST 1.1* as assessed by BIRC neuroradiologist.

  9. Intracranial Disease Control Rate (IDCR) [ Time Frame: Screening, followed by every 6 weeks until Month 18 after Month 18 every 9 weeks ]
    IDCR is defined as the DCR based on lesions in brain (target, non-target lesions (and new lesions, if applicable) and calculated as the proportion of patients with a best overall response of CR or PR or SD (or non-CR/nonPD) in the brain per modified RECIST 1.1* as assessed by BIRC neuro-radiologist.

  10. Duration of Intracranial Response (DOIR) [ Time Frame: Screening, followed by every 6 weeks until Month 18 after Month 18 every 9 weeks ]
    DOIR is defined as the DOR based on lesions in brain (target, non-target lesions (and new lesions, if applicable) and calculated from the time of first documented response of CR or PR to the date of the first documented disease progression in the brain or death due to any cause per modified RECIST 1.1* as assessed by BIRC neuro-radiologist.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient has a histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK) positive as assessed by the FDA approved Abbott FISH Test.
  2. Patient has stage IIIB or IV diagnosis and must have received one or two prior regimens (including platinum- doublet) of cytotoxic chemotherapy for the treatment of locally advanced or metastatic NSCLC.
  3. Patient has at least one measurable lesion as defined by RECIST 1.1. A previously irradiated site lesion may only be counted as a target lesion if there is clear sign of progression since the irradiation
  4. Patients must have received previous treatment with crizotinib for the treatment of locally advanced or metastatic NSCLC.

Exclusion Criteria:

  1. Patient with known hypersensitivity to any of the excipients of LDK378 (microcrystalline cellulose, mannitol, crospovidone, colloidal silicon dioxide and magnesium stearate)
  2. Patient with a history of severe hypersensitivity reaction to pemetrexed or docetaxel or any known excipients of these drugs.
  3. Patient with symptomatic central nervous system (CNS) metastases who is neurologically unstable or has required increasing doses of steroids within the 2 weeks prior to screening to manage CNS symptoms.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01828112


Locations
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Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01828112    
Other Study ID Numbers: CLDK378A2303
2012-005637-36 ( EudraCT Number )
First Posted: April 10, 2013    Key Record Dates
Results First Posted: July 27, 2017
Last Update Posted: November 30, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Non-Small Cell Lung Cancer
ALK
LDK378
Non-small cell lung carcinoma (NSCLC)
treatment of lung cancer after first metastasis
lung cancer
lung adenocarcinoma
 Non small cell lung carcinoma
Non small cell lung cancer
NSCLC
chemotherapy
ALK-positive
ALK-rearranged advanced non-small cell lung cancer
crizotinib
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Docetaxel
Pemetrexed
 Ceritinib
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors
Tyrosine Kinase Inhibitors
Protein Kinase Inhibitors