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

A real-world, open-label, multi-center, prospective, non-interventional (observational) study to evaluate the effectiveness and tolerability of ceritinib in Indian patients with ALK positive metastatic non-small cell lung cancer who have progressed or are intolerant to crizotinib. - CONNECT-CLDK378AIN01

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2016/09/007291

Enrollment

Registered

2016-09-19

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Indian patients with ALK positive metastatic non-small cell lung cancer who have progressed or are intolerant to crizotinib

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
The primary objective of this study is to assess clinical benefit rate associated with ceritinib treatment based on local treating physician assessment. Clinical benefit rate will be evaluated based on the objective tumor responses obtained for following response categories: CR, PR, stable disease or progressive disease according to the RECIST guidelines (version 1.1)1 and/or standard clinical practice.Timepoint: NA	—

Measure

Time frame

The primary objective of this study is to assess clinical benefit rate associated with ceritinib treatment based on local treating physician assessment. Clinical benefit rate will be evaluated based on the objective tumor responses obtained for following response categories: CR, PR, stable disease or progressive disease according to the RECIST guidelines (version 1.1)1 and/or standard clinical practice.Timepoint: NA

—

Secondary

Measure	Time frame
The secondary objective of this study is to evaluate tolerability of ceritinib, when used in patients with ALK-positive locally advanced or metastatic NSCLC.Timepoint: NA	—

Countries

India

Contacts

Public ContactDr Manish Mistry

Novartis India Limited

manish.mistry@novartis.com9820053069

Outcome results