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

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Pfizer

Status

Completed

Conditions

ALK-positive Non-small-cell Lung Cancer

Treatments

Drug: Lortlatinib

Study type

Observational

Funder types

Industry

Identifiers

NCT04979988
B7461038

Details and patient eligibility

About

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).

Full 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.

Enrollment

51 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

51 participants in 1 patient group

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
Treatment:
Drug: Lortlatinib

Trial documents
2

Trial contacts and locations

16

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Data sourced from clinicaltrials.gov

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