Study to Evaluate Clinical Real World Outcomes of Lorlatinib After Alectinib in ALK-Positive NSCLC Japanese Patients
NCT ID: NCT04979988
Last Updated: 2024-04-05
Study Results
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View full resultsBasic Information
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COMPLETED
51 participants
OBSERVATIONAL
2021-08-02
2021-12-09
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
RETROSPECTIVE
Study Groups
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Japanese patients with ALK+ NSCLC who received lorlatinib
lorlatinib as the second-line or later therapy after failure of alectinib treatment as the firstline therapy
Lortlatinib
as provided in real world practice
Interventions
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Lortlatinib
as provided in real world practice
Eligibility Criteria
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Inclusion Criteria
* 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
20 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Aichi Cancer Center Hospital
Nagoya, Aichi-ken, Japan
Fujita Health University Hospital
Toyoake, Aichi-ken, Japan
Kanagawa Cancer Center
Yokohama, Kanagawa, Japan
Kurashiki Central Hospital
Kurashiki, Okayama-ken, Japan
Kansai Medical University Hirakata Hospital
Hirakata, Osaka, Japan
Osaka International Cancer Institute
Osaka, Osaka, Japan
National Hospital Organization Kinki-Chuo Chest Medical Center
Sakai-shi, Osaka, Japan
Kinki University Hospital
Sayama, Osaka, Japan
Shizuoka Cancer Center
Sunto-gun, Shizuoka, Japan
Jichi Medical University Hospital
Shimotsuke, Tochigi, Japan
Juntendo University Hospital
Bunkyo-ku, Tokyo, Japan
National Hospital Organization Iwakuni Clinical Center
Iwakuni, Yamaguchi, Japan
National Hospital Organization, Yamaguchi-Ube Medical Center
Ube, Yamaguchi, Japan
The Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, , Japan
National Cancer Center
Tokyo, , Japan
Toyama Prefectural Central Hospital
Toyama, , Japan
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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B7461038
Identifier Type: -
Identifier Source: org_study_id
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