A phase III study of LDK378 versus standard chemotherapy in previously untreated ALK+, stage IIIB (not candidates for definitive multimodality therapy) or stage IV, non-squamous NSCLC
- Conditions
- non-squamous non-small cell lung cancer
- Registration Number
- JPRN-jRCT2080222158
- Lead Sponsor
- ovartis Pharma K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 376
1. Patient has a histologically or cytologically confirmed diagnosis of non-squamous NSCLC that is ALK positive as assessed by the Ventana IHC test. The test will be performed at Novartis designated central laboratories.
2. Patient has newly diagnosed stage IIIB (and is not a candidate for definitive multimodality therapy) or stage IV non-squamous NSCLC or relapsed locally advanced or metastatic non-squamous 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 neoadjuvant 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.
1. Patient with known hypersensitivity to any of the excipients of LDK378
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 CNS metastases who is neurologically unstable or has required increasing doses of steroids within the 2 weeks prior to screening to manage CNS symptoms.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method