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

NCT04351334 | Completed Results

• 1 other identifier: B7461031
• Study Type: observational
• Target: 161
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non-Small-Cell Lung Carcinoma

Outcome Measures

Primary Outcomes (5)

• Number of Participants Classified According to Treatments Received for Anaplastic Lymphoma Kinase Positive-non-Small Cell Lung Cancer (ALK + NSCLC) in Sequence

  Number of participants classified according to ALK-TKI treatment patterns or sequencing were reported in this outcome measure.

  During the inclusion period from 01-Jun-2017 to 31-Aug-2020 (maximum up to 39 months); eligible data was studied during approximately 31 months of this retrospective study

• Number of Participants Classified According to Reason for Alectinib Treatment Discontinuation

  Number of participants classified according to reason for Alectinib treatment discontinuation were reported in this outcome measure. One participant could have more than one reason for discontinuation.

  From initiation of index treatment to discontinuation from 01-Jun-2017 to 31-Aug-2021 (maximum up to 51 months); eligible data was studied during approximately 31 months of this retrospective study

• Duration of Therapy (DOT)

  DOT was defined as duration of time between alectinib or post-alectinib treatment initiation and discontinuation as documented in the iKM EHR database. Participants who did not have evidence of discontinuation, starting new therapy, or whose last prescription date was less than (\<) 30 days from the end of the study period, were censored at last visit date or end of study period.

  Alectinib or post-alectinib treatment initiation till its discontinuation or censoring date, during study observation period (maximum up to 51 months); eligible data was studied during approximately 31 months of this retrospective study

• Overall Survival (OS)

  OS was defined as the interval between treatment and the date of death (any cause) as documented in the iKM EHR database. Participants who did not die within the study observation period were censored on the study end date or the last visit date available in the dataset, whichever occurred first.

  From start of treatment until date of death or censoring date, during study observation period (maximum up to 51 months); eligible data was studied during approximately 31 months of this retrospective study

• Progression Free Survival (PFS)

  PFS was measured from the initiation of the treatment to the date of progression (documented by provider as disease has progressed or worsening of disease) or date of death due to any cause, censoring participants who were still alive at the end of the study observation period and did not progress at the last visit date.

  From initiation of index treatment to date of progression or death due to any cause or censoring date, during study observation period (maximum up to 51 months); eligible data was studied during approximately 31 months of this retrospective study

Study Arms (1)

Patients with ALK-positive NSCLC

Drug: Alectinib

Interventions

Alectinib DRUG

Observational treatment based on physician choice

Patients with ALK-positive NSCLC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of patients with a diagnosis of NSCLC receiving alectinib.

You may qualify if:

• Patients with a documented diagnosis of NSCLC.
• Patients ≥ 18 years of age at initial recorded diagnosis of NSCLC.
• 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.
• During the study observation period, patients observed with at least 2 visits after the index date-1.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Inc

New York, New York, 10017, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

alectinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2020
• First Posted: April 17, 2020
• Study Start: March 1, 2020
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)