Anaplastic Lymphoma Kinase (ALK)-Positive Non-small Cell Lung Cancer (NSCLC) Post-alectinib Treatment Patterns

NCT ID: NCT04351334

Last Updated: 2024-09-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

161 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-01

Study Completion Date

2022-11-01

Brief Summary

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This study aims to understand patient profiles, treatment patterns, and clinical outcomes among ALK-positive NSCLC patients treated with alectinib, and post-alectinib treatment patterns and outcomes.

Detailed Description

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Conditions

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Non-Small-Cell Lung Carcinoma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients with ALK-positive NSCLC

Alectinib

Intervention Type DRUG

Observational treatment based on physician choice

Interventions

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Alectinib

Observational treatment based on physician choice

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Patients with a documented diagnosis of NSCLC.
2. Patients ≥ 18 years of age at initial recorded diagnosis of NSCLC.
3. Patients who received treatment with alectinib during the study identification period, including those who initiated alectinib prior (index date-1) to the start of the study identification period.
4. During the study observation period, patients observed with at least 2 visits after the index date-1.

Exclusion Criteria

1. Receipt of treatment indicated for another primary cancer or diagnosis of another primary cancer (with the exception of non-melanotic skin cancer), within 5 years of index date-1 will be excluded.
2. Patients enrolled in clinical trials prior to receiving alectinib during the study ID period (index date-1), will be included and flagged in the analysis.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Inc

New York, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=B7461031

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Other Identifiers

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B7461031

Identifier Type: -

Identifier Source: org_study_id

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