Study to Evaluate Clinical Real World Outcomes of Lorlatinib After Alectinib in ALK-Positive NSCLC Japanese Patients

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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