A observational study to check the effectiveness and safety of ceritinib in patients with non small cell lung cancer who are ALK positive and who have progessed to crizotinib
- Conditions
- Health Condition 1: null- Indian patients with ALK positive metastatic non-smallcell lung cancer who have progressed or are intolerant to crizotinib
- Registration Number
- CTRI/2016/09/007291
- Lead Sponsor
- ovartis Healthcare Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 50
1. Willing to provide signed ICF indicating that he/she understand the purpose and are
willing to participate in the study.
2. Patient is 18 years of age or older at the time of informed consent.
3. Patient with ALK-positive metastatic NSCLC who has progressed on or is intolerant
to crizotinib.
4. Patient being newly initiated on ceritinib treatment based on independent clinical
judgment of treating physician as per locally approved prescribing information.
1. Patient who is not eligible to receive ceritinib as per the locally approved prescribing
information.
2. Patient with known hypersensitivity to any of the excipients of ceritinib
(microcrystalline cellulose, mannitol, crospovidone, colloidal silicon dioxide, and
magnesium stearate).
3. Patient with any contraindication as per the locally approved prescribing information.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective of this study is to assess clinical benefit rate associated with ceritinib <br/ ><br>treatment based on local treating physician assessment. Clinical benefit rate will be evaluated <br/ ><br>based on the objective tumor responses obtained for following response categories: CR, PR, <br/ ><br>stable disease or progressive disease according to the RECIST guidelines (version 1.1)1 and/or <br/ ><br>standard clinical practice.Timepoint: NA
- Secondary Outcome Measures
Name Time Method The secondary objective of this study is to evaluate tolerability of ceritinib, when used in <br/ ><br>patients with ALK-positive locally advanced or metastatic NSCLC.Timepoint: NA