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).
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).
Active, not recruiting
Phase 3
NCT ID: NCT01828099
ORG ID: CLDK378A2301
NCI ID: 2013-000319-26
Non-Small Cell Lung Cancer
Drug | Synonyms | Arms |
---|---|---|
LDK378 | LDK378 | |
Pemetrexed + cisplatin or pemetrexed + carboplatin | Reference Chemotherapy |
The primary purpose of the study is to compare the antitumor activity of LDK378 versus
reference chemotherapy.
Name | Type | Description | Interventions |
---|---|---|---|
LDK378 | Experimental | LDK378 | |
Reference Chemotherapy | Active Comparator | Pemetrexed + cisplatin or pemetrexed + carboplatin |
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
Progression Free Survival (PFS)
Overall Survival (OS)
Overall Response Rate (ORR)
Duration of Response (DOR)
Disease Control Rate (DCR)
Time to response (TTR)
Patient Reported Outcomes
Non-Small Cell Lung Cancer, ALK, LDK378