Lung CancerNCT06321510
A Study to Learn About Dacomitinib in Patients With Non-small Cell Lung Cancer.
An observational study of Lung Cancer, run by Pfizer at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- How many people
- 29 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jul 2024to 19 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with non-small cell lung cancer and treated with dacomitnib in medical center or regional hospital will be enrolled.
Who may be able to join
- 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.
Who cannot join
- Patients who have been treated with any systemic anti-cancer therapies within 12 months prior to dacomitinib treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
The purpose of this study is to learn about dacomitinib for the possible treatment of lung cancer.
This study is seeking participants who:
Read more
- 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
- Medical subject headings
- Lung Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 52 months from index date
Secondary outcomes (5)
Real-world overall survival (rwOS)
Time to death from index date during follow-up period will be summarized by K-M plot with corresponding 95% CI.
Measured: 52 months from index date
Real-world progression-free survival
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.
Measured: 52 month from index date
Real-world best objective response rate (rwORR)
Number and percentage of patients achieving real-worl overall response (CR or PR).
Measured: 52 months from index date
real-world intracranial response rate (rwIC-ORR)
The percentage of patients achieving real-world intracranial response (CR or PR) for brain metastases during follow-up period will be summarized.
Measured: 52 months from index date
real-world extracranial response rate (rwEC-ORR)
The percentage of patients achieving real-world extracranial response (CR or PR) for brain metastases during follow-up period will be summarized.
Measured: 52 months from index date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start1 Jul 2024
- Primary completion19 Sep 2025
- Study completion19 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06321510
- Sponsor's protocol ID
- A7471070
- Other IDs
- NCT06321510
- Status last verified
- May 2026
- First submitted
- 13 Mar 2024
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06321510
- Acronym / sponsor ID
- A7471070
- Conditions
- Lung Cancer
- Keywords
- EGFR, NSCLC, brain, CNS, dacomitinib
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 19 Sep 2025 (actual)
- Study completion
- 19 Sep 2025 (actual)
- First posted
- 20 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with non-small cell lung cancer and treated with dacomitnib in medical center or regional hospital will be enrolled.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients who have been treated with any systemic anti-cancer therapies within 12 months prior to dacomitinib treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
5 secondary outcomes
Real-world overall survival (rwOS)
Time frame: 52 months from index date
Real-world progression-free survival
Time frame: 52 month from index date
Real-world best objective response rate (rwORR)
Time frame: 52 months from index date
real-world intracranial response rate (rwIC-ORR)
Time frame: 52 months from index date
real-world extracranial response rate (rwEC-ORR)
Time frame: 52 months from index date
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by Pfizer at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with dacomitinib dosage change and reasons (time frame: 52 months from index date). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.