Brief Title
Study to Evaluate Clinical Real World Outcomes of Lorlatinib After Alectinib in ALK-Positive NSCLC Japanese Patients
Official Title
Retrospective, Multicenter, Observational Study to Evaluate Clinical Real World Outcomes of Lorlatinib After Alectinib in ALK-Positive NSCLC Japanese Patients
Brief Summary
To evaluate the clinical real world outcomes of lorlatinib in second/later line setting anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI) to TKI sequence sequence treatment after failure of alectinib as a first-line treatment in Japanese ALK positive non-small cell lung cancer (NSCLC).
Detailed Description
This study is a post-approval, company-sponsored, observational study. This study is a multicenter, non-interventional, retrospective, chart review of patients with ALK+ NSCLC patients treated using lorlatinib as the second/later line therapy in Japan after failure of alectinib treatment as the first line therapy from 20 November 2018. All decisions regarding clinical management and treatment of the participating patients were made by an investigator as part of standard care in real-world clinical setting and were not contingent upon the patient's participation in the study. Data will be collected if available per study site. Patients in this study are those who started treatment with lorlatinib from 1 May 2019 to 31 December, 2020 in clinical practice.
Study Type
Observational
Primary Outcome
Description of patient characteristics at baseline (at the timing of alectinib initiation date) and at lorlatinib initiation date
Secondary Outcome
- Reason for discontinuation of each treatment line therapy
Condition
ALK-positive Non-small-cell Lung Cancer
Intervention
Lortlatinib
Study Arms / Comparison Groups
Japanese patients with ALK+ NSCLC who received lorlatinib
Description: lorlatinib as the second-line or later therapy after failure of alectinib treatment as the firstline therapy
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
51
Start Date
August 2, 2021
Completion Date
December 9, 2021
Primary Completion Date
December 9, 2021
Eligibility Criteria
Inclusion Criteria: - Histologically or cytologically confirmed NSCLC, with any tumor, node and metastasis (TNM) stage. - Confirmed ALK gene rearrangement by any validated test. - Confirmed the treatment with alectinib in the first line setting as systemic therapy in the medical record. - Confirmed the start treatment with lorlatinib as the second/later-line therapy from 1st May 2019 to 31st December 2020. Exclusion Criteria: -Participating on any clinical trials of which final results has not yet been reported during the study period.
Gender
All
Ages
20 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Pfizer CT.gov Call Center, ,
Location Countries
Japan
Location Countries
Japan
Administrative Informations
NCT ID
NCT04979988
Organization ID
B7461038
Responsible Party
Sponsor
Study Sponsor
Pfizer
Study Sponsor
Pfizer CT.gov Call Center, Study Director, Pfizer
Verification Date
January 2022