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

• Sponsor: Pfizer (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04351334
• Collaborator: (none)
• Enrollment: 1
• Location: 1
• Anticipated Duration (Months): 39.1
• Patients Per Site Per Month: 0

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non-Small-Cell Lung Carcinoma	Drug: Alectinib

Study Design

• Study Type: Observational
• Actual Enrollment: 1 participants
• Observational Model: Case-Only
• Time Perspective: Retrospective
• Official Title: Patient Profiles and Treatment Patterns Among ALK-positive NSCLC Patients Treated With Alectinib
• Actual Study Start Date: Mar 27, 2020
• Anticipated Primary Completion Date: Jul 1, 2023
• Anticipated Study Completion Date: Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Patients with ALK-positive NSCLC	Drug: Alectinib; Observational treatment based on physician choice

Outcome Measures

Primary Outcome Measures

1. Duration of therapy [June 2017 to December 2019]

2. ALK TKI treatment patterns and sequencing [June 2017 to December 2019]

Secondary Outcome Measures

1. Overall Survival [June 2017 to December 2019]

2. Treatment discontinuation [June 2017 to December 2019]

3. Progression free survival [June 2017 to December 2019]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 within USON or Onmark during 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Inc	New York	New York	United States	10017

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT04351334
• Other Study ID Numbers: B7461031
• First Posted: Apr 17, 2020
• Last Update Posted: Apr 13, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Carcinoma, Non-Small-Cell Lung

Study Results

No Results Posted as of Apr 13, 2022