Clinical Trials /

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

NCT01828099

Description:

The primary purpose of the study was to compare the antitumor activity of LDK378 versus reference chemotherapy. Patients in the chemotherapy arm were allowed to cross-over to LDK378 after confirmed progressive disease (PD).

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 3

Trial Eligibility

Document

<span class="go-doc-concept go-doc-intervention">LDK378</span> Versus <span class="go-doc-concept go-doc-intervention">Chemotherapy</span> in Previously Untreated Patients With <span class="go-doc-concept go-doc-biomarker">ALK</span> <span class="go-doc-concept go-doc-keyword">Rearranged</span> Non-small Cell <span class="go-doc-concept go-doc-disease">Lung Cancer</span>

Title

  • Brief Title: LDK378 Versus Chemotherapy in Previously Untreated Patients With ALK Rearranged Non-small Cell Lung Cancer
  • 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
  • Clinical Trial IDs

    NCT ID: NCT01828099

    ORG ID: CLDK378A2301

    NCI ID: 2013-000319-26

    Trial Conditions

    Non-Small Cell Lung Cancer

    Trial Interventions

    Drug Synonyms Arms
    LDK378 LDK378
    Pemetrexed + cisplatin or pemetrexed + carboplatin Reference Chemotherapy

    Trial Purpose

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

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    LDK378 Experimental LDK378
    Reference Chemotherapy Active Comparator Pemetrexed + cisplatin or pemetrexed + carboplatin

    Eligibility 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.

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Progression Free Survival (PFS)

    Secondary Outcome Measures

    Overall Survival (OS)

    Overall Response Rate (ORR)

    Duration of Response (DOR)

    Disease Control Rate (DCR)

    Time to response (TTR)

    Patient Reported Outcomes

    Trial Keywords

    Non-Small Cell Lung Cancer, ALK, LDK378