A Study to Learn About Dacomitinib in Patients With Non-small Cell Lung Cancer.

NCT06321510 | Completed

• 2 other identifiers: A7471070NCT06321510
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to learn about dacomitinib for the possible treatment of lung cancer. This study is seeking participants who:

• have lung cancer that could not be controlled.
• have a type of gene called epidermoid growth factor receptor. A gene is a part of your DNA that has instructions for making things your body needs to work.
• have received dacomitinib for their lung cancer. All participants in this study had received dacomitinib. Dacomitinib is a tablet that is taken by mouth at home. They continued to take dacomitnib until their cancer was no longer responding. The study will look at the experiences of people receiving the study medicine. This will help to see if the study medicine is safe and effective.

Conditions

Lung Cancer

Keywords

EGFR; NSCLC; brain; CNS; dacomitinib

Outcome Measures

Primary Outcomes (2)

• Percentage of patients with dacomitinib dosage change and reasons

  The percentage of patients with dacomitinib dosage change and reason during follow-up period will be summarized.

  52 months from index date

• Percentage of patients with dacomitinib treatment discontinuation

  The percentage of patients with dacomitinib treatment discontinuation for any reason during follow-up period will be summarized.

  52 months from index date

Secondary Outcomes (5)

• Real-world overall survival (rwOS)

  52 months from index date

• Real-world progression-free survival

  52 month from index date

• Real-world best objective response rate (rwORR)

  52 months from index date

• real-world intracranial response rate (rwIC-ORR)

  52 months from index date

• real-world extracranial response rate (rwEC-ORR)

  52 months from index date

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

Patients with non-small cell lung cancer and treated with dacomitnib in medical center or regional hospital will be enrolled.

You may qualify if:

• Evidence of histologically or cytologically confirmed diagnosis of advanced NSCLC with EGFR-activating mutations detected by an appropriate test
• Patients who were treated with dacomitinib as first-line treatment for advanced NSCLC during 01 October 2020 to 31 December 2022.
• Age ≥18 years old
• Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

You may not qualify if:

• Patients who have been treated with any systemic anti-cancer therapies within 12 months prior to dacomitinib treatment.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Tri-Service General Hospital

Taipei, 11490, R.O.C., Taiwan

Location

Related Links

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

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: March 20, 2024
• Study Start: July 1, 2024
• Primary Completion: September 19, 2025
• Study Completion: September 19, 2025
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)