Health conditions
(Datenquelle: WHO)
Non-Small Cell Lung Cancer
Interventions (Datenquelle: WHO)
Drug: Ceritinib;Drug: pemetrexed;Drug: docetaxel
Inclusion/Exclusion Criteria
(Datenquelle: 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.
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Weitere Informationen zur Studie
Rekrutierungsstatus
Completed
Wissenschaftlicher Titel
(Datenquelle: 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
Studientyp
(Datenquelle: WHO)
Interventional
Design der Studie
(Datenquelle: WHO)
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Phase
(Datenquelle: WHO)
Phase 3
Primäre Endpunkte
(Datenquelle: WHO)
Progression Free Survival (PFS) Blinded Independent Review Committee Per Blinded Independent Review Committee (BIRC)
Sekundäre Endpunkte
(Datenquelle: 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)
Kontakt für Auskünfte
(Datenquelle: WHO)
Please refer to primary and secondary sponsors
Ergebnisse der Studie
(Datenquelle: WHO)
Zusammenfassung der Ergebnisse
noch keine Angaben verfügbar
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
noch keine Angaben verfügbar
Studiendurchführungsorte
Durchführungsländer
(Datenquelle: 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
Kontakt für weitere Auskünfte zur Studie
Kontakt für allgemeine Auskünfte
(Datenquelle: WHO)
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Kontakt für wissenschaftliche Auskünfte
(Datenquelle: WHO)
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Weitere Studienidentifikationsnummern
Secondary ID (Datenquelle: WHO)
2012-005637-36
CLDK378A2303
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