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NCT04351334 Clinical Trial

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

Non-Small-Cell Lung Carcinoma Clinical Trial

Official title:
Patient Profiles and Treatment Patterns Among ALK-positive NSCLC Patients Treated With Alectinib

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04351334
Other study ID # B7461031
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 27, 2020
Est. completion date November 1, 2022

Study information
Verified date March 2023
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 1
Est. completion date November 1, 2022
Est. primary completion date November 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Alectinib
Observational treatment based on physician choice

Locations
Country Name City State
United States Pfizer Inc New York New York

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary ALK TKI treatment patterns and sequencing June 2017 to August 31, 2021
Primary Duration of therapy June 2017 to August 31, 2021
Primary Reasons for treatment discontinuation June 2017 to August 31, 2021
Primary Progression free survival June 2017 to August 31, 2021
Primary Overall Survival June 2017 to August 31, 2021
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