Health conditions
(Source de données: WHO)
Non-Small Cell Lung Cancer
Interventions (Source de données: WHO)
Drug: Ceritinib;Drug: pemetrexed;Drug: docetaxel
Inclusion/Exclusion Criteria
(Source de données: WHO)
Gender: All
Maximum age: N/A
Minimum age: 18 Years
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.
-
Plus d’informations sur l’étude
Statut de recrutement
Completed
Titre scientifique
(Source de données: WHO)
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
Type d’étude
(Source de données: WHO)
Interventional
Conception de l’étude
(Source de données: WHO)
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Phase
(Source de données: WHO)
Phase 3
Points finaux primaires
(Source de données: WHO)
Progression Free Survival (PFS) Blinded Independent Review Committee Per Blinded Independent Review Committee (BIRC)
Points finaux secondaires
(Source de données: WHO)
Overall Survival (OS);Overall Response Rate (ORR);Duration of Response (DOR);Disease Control Rate (DCR);Time to Response (TTR);Patient Reported Outcomes (PRO);Time to Definitive Deterioration;Overall Intracranial Response Rate (OIRR);Intracranial Disease Control Rate (IDCR);Duration of Intracranial Response (DOIR)
Contact pour informations
(Source de données: WHO)
Please refer to primary and secondary sponsors
Résultats de l’étude
(Source de données: WHO)
Résumé des résultats
pas encore d’informations disponibles
Informations sur la disponibilité des données individuelles des participants
pas encore d’informations disponibles
Lieux de réalisation des études
Pays où sont réalisées les études
(Source de données: WHO)
Belgium, Canada, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Korea, Lebanon, Netherlands, Portugal, Republic of, Russian Federation, Singapore, Spain, Switzerland, Turkey, United Kingdom, United States
Contact pour plus d’informations sur l’étude
Contact pour des informations générales
(Source de données: WHO)
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Contact pour des informations scientifiques
(Source de données: WHO)
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Plus de numéros d’identification d’étude
Secondary ID (Source de données: WHO)
2012-005637-36
CLDK378A2303
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