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Completed

NCT Number: NCT06321510

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tri-Service General Hospital

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Percentage of patients with dacomitinib dosage change and reasons

    Time frame: 52 months from index date

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

  2. Percentage of patients with dacomitinib treatment discontinuation

    Time frame: 52 months from index date

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

Secondary outcomes

  1. Real-world overall survival (rwOS)

    Time frame: 52 months from index date

    Time to death from index date during follow-up period will be summarized by K-M plot with corresponding 95% CI.

  2. Real-world progression-free survival

    Time frame: 52 month from index date

    Time to real-world disease progression or death, which ever occurs first, during follow-up period will be summarized by K-M plot with corrsponding 95% CI.

  3. Real-world best objective response rate (rwORR)

    Time frame: 52 months from index date

    Number and percentage of patients achieving real-worl overall response (CR or PR).

  4. real-world intracranial response rate (rwIC-ORR)

    Time frame: 52 months from index date

    The percentage of patients achieving real-world intracranial response (CR or PR) for brain metastases during follow-up period will be summarized.

  5. real-world extracranial response rate (rwEC-ORR)

    Time frame: 52 months from index date

    The percentage of patients achieving real-world extracranial response (CR or PR) for brain metastases during follow-up period will be summarized.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

REAL-WORLD TREATMENT PATTERNS AND CLINICAL EFFECTIVENESS OF DACOMITINIB IN ADVANCED NON-SMALL CELL LUNG CANCER PATIENTS WITH EPIDERMAL GROWTH FACTOR RECEPTOR-POSITIVE IN TAIWAN

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 20, 2024
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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