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LDK378 Versus Chemotherapy in Previously Untreated Patients With ALK Rearranged Non-small Cell Lung Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01828099
First received: April 3, 2013
Last updated: September 9, 2014
Last verified: September 2014
  Purpose

The primary purpose of the study is to compare the antitumor activity of LDK378 versus reference chemotherapy.


Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: LDK378
Drug: Pemetrexed + cisplatin or pemetrexed + carboplatin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III Multicenter, Randomized Study of Oral LDK378 Versus Standard Chemotherapy in Previously Untreated Adult Patients With ALK Rearranged (ALK-positive), Stage IIIB or IV, Non-squamous Non-small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Progression Free Survival (PFS) [ Time Frame: Month 33 ] [ Designated as safety issue: No ]
    PFS defined as time from date of randomization to date of first documented disease (as assessed by Blinded Independent Review Committee (BIRC) per RECIST 1.1) or date of death due to any cause


Secondary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: Month 33 ] [ Designated as safety issue: No ]
    OS defined as time from date of randomization to date of death due to any cause

  • Overall Response Rate (ORR) [ Time Frame: Month 33 ] [ Designated as safety issue: No ]
    ORR defined as the proportion of patients with a best overall response defined as Complete Response (CR) or Partial Response (PR) as evaluated by Blinded Independent Review Committee (BIRC) and by investigator assessment per RECIST 1.1

  • Duration of Response (DOR) [ Time Frame: Month 33 ] [ Designated as safety issue: No ]
    DOR defined as the time from date of first documented CR or PR to date of first documented disease progression or death due to any cause

  • Disease Control Rate (DCR) [ Time Frame: Month 33 ] [ Designated as safety issue: No ]
    DCR defined as the proportion of patients with best overall response of CR, PR, or Stable Disease (SD)

  • Time to response (TTR) [ Time Frame: Month 33 ] [ Designated as safety issue: No ]
    TTR defined as the time from date of randomization to date of first documented response (CR or PR)

  • Patient Reported Outcomes [ Time Frame: Screening, followed by every 6 weeks until Month 33 after Month 33 every 9 weeks. ] [ Designated as safety issue: No ]
    The time to definitive deterioration from the date of randomization to the date of event for disease related symptoms.


Estimated Enrollment: 348
Study Start Date: July 2013
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LDK378 Drug: LDK378
Oral LDK378 750 mg once daily
Active Comparator: Reference Chemotherapy Drug: Pemetrexed + cisplatin or pemetrexed + carboplatin
Pemetrexed 500 mg/m² plus cisplatin 75 mg/m² every 21 days for 4 cycles followed by pemetrexed 500 mg/m² every 21 days or pemetrexed 500 mg/m² plus carboplatin AUC 5-6 every 21 days for 4 cycles followed by pemetrexed 500 mg/m² every 21 days

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient has a histologically or cytologically confirmed diagnosis of non-squamous Non-small cell lung cancer (NSCLC) that is Anaplastic lymphoma kinase (ALK) positive as assessed by the Ventana Immunohistochemistry (IHC) test. The test will be performed at Novartis designated central laboratories.
  2. Patient has newly diagnosed stage IIIB (who are not a candidate for definitive multimodality therapy) or stage IV NSCLC or relapsed locally advanced or metastatic NSCLC not previously treated with any systemic anti-cancer therapy (e.g. cytotoxic drugs, monoclonal antibody therapy, crizotinib or other ALK inhibitors, or other targeted therapies, either experimental or not), with exception of neo-adjuvant or adjuvant therapy
  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

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 platinum containing drugs, pemetrexed 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01828099

Contacts
Contact: Novartis Pharmaceuticals +41613241111
Contact: Novartis Pharmaceuticals

  Show 212 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01828099     History of Changes
Other Study ID Numbers: CLDK378A2301, 2013-000319-26
Study First Received: April 3, 2013
Last Updated: September 9, 2014
Health Authority: United States: Food and Drug Administration
Austria: Agency for Health and Food Safety
Brazil: Ministry of Health
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
France: Haute Autorité de Santé Transparency Commission
Germany: Federal Institute for Drugs and Medical Devices
Greece: Ministry of Health and Welfare
Hungary: National Institute of Pharmacy
India: Drugs Controller General of India
Italy: Ministry of Health
Japan: Ministry of Health, Labor and Welfare
Lebanon: Ministry of Public Health
Netherlands: Medicines Evaluation Board (MEB)
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Russia: Ministry of Health of the Russian Federation
Singapore: Health Sciences Authority
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
Taiwan: Department of Health
Thailand: Food and Drug Administration
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
China: Food and Drug Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Denmark: Danish Medicines Agency
Finland: Finnish Medicines Agency
Norway: Norwegian Medicines Agency
Ireland: Ministry of Health
Mexico: Ministry of Health
New Zealand: Ministry of Health
Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Novartis:
Non-Small Cell Lung Cancer, ALK, LDK378

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Carboplatin
Cisplatin
Pemetrexed
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014