Carcinoma, Non-Small-Cell LungNCT06075615
A Study to Learn About Dacomitnib in Patients With Non-small Cell Lung Cancer Which Has Spread to the Brain.
An observational study of Carcinoma, Non-Small-Cell Lung, run by Pfizer.
Trial summary
The purpose of this study is to learn about dacomitinib for the possible treatment of lung cancer which has spread to other parts of the body. This study is seeking participants who: have lung cancer that has reached at least the brain. 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
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- dacomitnib
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2024to 7 Sep 2026
- 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: Adults with epidermoid growth factor receport (EGFR)-positive non-small cell lung cancer (NSCLC) with brain metastasis
Who may be able to join
- at least 18 years old
- confirmed diagnosis of EGFR mutation-positive NSCLC
- at least one measurable intracranial metastasis
- ECOG-PS of 0, 1 or 2
- dacomitinib as first-line treatment for advanced NSCLC
- Evidence of a personally signed and dated informed consent document (ICD)
Who cannot join
- any anti-cancer systemic treatment within 12 months prior to index date
- currently on active investigational drug(s) treatment in other clinical studies (Phase 1-4) within 2 weeks before the current study begins and/or during study participation.
About this study
Official title: A Multicenter, Observational Study to Describe the Effectiveness and Treatment Patterns of Dacomitinib Among Epidermal Growth Factor Receptor Mutation-Positive Non-Small Cell Lung Cancer Patients With Brain Metastasis
The purpose of this study is to learn about dacomitinib for the possible treatment of lung cancer which has spread to other parts of the body.
This study is seeking participants who:
Read more
- have lung cancer that has reached at least the brain.
- 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 not received any treatment before.
All participants in this study will receive dacomitnib 1 time a day. Dacomitinib is a tablet that is taken by mouth at home. They can continue to take dacomitnib until their cancer is 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
- Carcinoma, Non-Small-Cell Lung
- Being tested
- dacomitnib
- Keywords
- Dacomitinib, Non-Small Cell Lung Cancer, Brain Metastasis
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dacomitnibDrug
patients with dacomitnib as first line treatment for advanced NSCLC with brain metastasis
| Study group | Role | What they receive |
|---|---|---|
| dacomitnib | Not described Receives: Drug: dacomitnib |
What is being measured
The primary outcome is the main question the study is designed to answer.
The real-world intracranial overall response rate (rwICORR) at Month 3
The percentage of patients achieving real-world intracranial overall response (complete response (CR) or partial response (PR)) for brain metastases at Month 3 (± 4 weeks) will be summarized.
Measured: 3 months from first dose of dcomitnib
The real-world intracranial overall response rate (rwICORR) at Month 6
The percentage of patients achieving real-world intracranial overall response (CR or PR) for brain metastases at Month 6 (± 4 weeks) will be summarized.
Measured: 6 months from first dose of dacomitnib
The real-world intracranial overall response rate (rwICORR) at Month 12
The percentage of patients achieving real-world intracranial overall response (CR or PR) for brain metastases at Month 12 (± 4 weeks) will be summarized.
Measured: 12 months from first dose of dacomitinib
The real-world intracranial clinical benefit rate (rwICBR) at Month 3
The percentage of patients with real-world intracranial clinical benefit (CR, PR or SD) for brain metastases at Month 3 (± 4 weeks) will be summarized
Measured: 3 months from first dose of dacomitinib
The real-world intracranial clinical benefit rate (rwICBR) at Month 6
The percentage of patients with real-world intracranial clinical benefit (CR, PR or SD) for brain metastases at Month 6 (± 4 weeks) will be summarized
Measured: 6 months from first dose of dacomitinib
The real-world intracranial clinical benefit rate (rwICBR) at Month 12
The percentage of patients with real-world intracranial clinical benefit (CR, PR or SD) for brain metastases at Month 12 (± 4 weeks) will be summarized
Measured: 12 months from first dose of dacomitinib
The real-world intracranial time to progression (rwICTTP)
The mean and median of the time to the date of the first documentation of real-world progression of intracranial disease.
Measured: 30 months from first dose of dacomitinib
The real-world systemic overall response rate (rwORR) at Month 3
The number and percentage of patients achieving real-world systemic overall response (CR or PR) for brain metastases at Month 3 (± 4 weeks) will be summarized.
Measured: 3 months from first dose of dacomitinib
The real-world systemic overall response rate (rwORR) at Month 6.
The number and percentage of patients achieving real-world systemic overall response (CR or PR) for brain metastases at Month 6 (± 4 weeks) will be summarized.
Measured: 6 months from first dose of dacomitinib
The real-world systemic overall response rate (rwORR) at Month 12.
The number and percentage of patients achieving real-world systemic overall response (CR or PR) for brain metastases at Month 12 (± 4 weeks) will be summarized.
Measured: 12 months from first dose of dacomitinib
The real-world progression-free survival (rwPFS) during 12 months from index date
Time to real-world disease progression or death, whichever occurs first, during 12 months from index date will be summarized by the K-M plot with the corresponding 95% CI.
Measured: 12 months from index date
The real-world overall survival (rwOS) during 12 months from index date
Time to real-world death during 12 months from index date will be summarized by the K-M plot with the corresponding 95% CI.
Measured: 12 months from index date
The real-world overall survival (rwOS) during 24 months from index date
Time to real-world death during 24 months from index date will be summarized by the K-M plot with the corresponding 95% CI.
Measured: 24 months from index date
Secondary outcomes (5)
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: 30 months from first dose of dacomitinib
Time to dacomitinib treatment discontinuation
Time to dacomitinib treatment discontinuation during follow-up period will be summarized by the K-M plot with the corresponding 95% CI.
Measured: 30 months from first dose of dacomitinib
Number of patients with dacomitinib dosage change and reasons
The number of patients with dacomitinib dosage change and reason during follow-up period will be summarized.
Measured: 30 months from first dose of dacomitinib
Time to dacomitinib dosage change
Time to dacomitinib dosage change during follow-up period will be summarized by the K-M plot with the corresponding 95% CI.
Measured: 30 months from first dose of dacomitinib
Concomitant NSCLC-related treatment
The number patients with concomitant NSCLC-related treatment will be summarized.
Measured: 30 months from first dose of dacomitinib
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start30 Sep 2024 (estimated)
- Primary completion7 Sep 2026 (estimated)
- Study completion7 Sep 2026 (estimated)
Why it stopped: Sponsor Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies 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
- Prospective
- Enrolment
- 0 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
- NCT06075615
- Sponsor's protocol ID
- A7471072
- Other IDs
- NCT06075615
- Status last verified
- Feb 2025
- First submitted
- 18 Sep 2023
- Last updated
- 7 Feb 2025
- 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 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Observational Study to Describe the Effectiveness and Treatment Patterns of Dacomitinib Among Epidermal Growth Factor Receptor Mutation-Positive Non-Small Cell Lung Cancer Patients With Brain Metastasis
- ClinicalTrials.gov ID
- NCT06075615
- Acronym / sponsor ID
- A7471072
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- Dacomitinib, Non-Small Cell Lung Cancer, Brain Metastasis
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Sponsor Decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2024 (estimated)
- Primary completion
- 7 Sep 2026 (estimated)
- Study completion
- 7 Sep 2026 (estimated)
- First posted
- 10 Oct 2023 (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 which has spread to other parts of the body.
This study is seeking participants who:
- have lung cancer that has reached at least the brain.
- 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 not received any treatment before.
All participants in this study will receive dacomitnib 1 time a day. Dacomitinib is a tablet that is taken by mouth at home. They can continue to take dacomitnib until their cancer is 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
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dacomitnib | – | Drug: dacomitnib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with epidermoid growth factor receport (EGFR)-positive non-small cell lung cancer (NSCLC) with brain metastasis
Key inclusion criteria (6 listed)
- at least 18 years old
- confirmed diagnosis of EGFR mutation-positive NSCLC
- at least one measurable intracranial metastasis
- ECOG-PS of 0, 1 or 2
- dacomitinib as first-line treatment for advanced NSCLC
Key exclusion criteria (2 listed)
- any anti-cancer systemic treatment within 12 months prior to index date
- currently on active investigational drug(s) treatment in other clinical studies (Phase 1-4) within 2 weeks before the current study begins and/or during study participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dacomitnibpatients with dacomitnib as first line treatment for advanced NSCLC with brain metastasis | Drug | dacomitnib |
Primary outcome
The real-world intracranial overall response rate (rwICORR) at Month 3
Time frame: 3 months from first dose of dcomitnib
The percentage of patients achieving real-world intracranial overall response (complete response (CR) or partial response (PR)) for brain metastases at Month 3 (± 4 weeks) will be summarized.
The real-world intracranial overall response rate (rwICORR) at Month 6
Time frame: 6 months from first dose of dacomitnib
The percentage of patients achieving real-world intracranial overall response (CR or PR) for brain metastases at Month 6 (± 4 weeks) will be summarized.
The real-world intracranial overall response rate (rwICORR) at Month 12
Time frame: 12 months from first dose of dacomitinib
The percentage of patients achieving real-world intracranial overall response (CR or PR) for brain metastases at Month 12 (± 4 weeks) will be summarized.
The real-world intracranial clinical benefit rate (rwICBR) at Month 3
Time frame: 3 months from first dose of dacomitinib
The percentage of patients with real-world intracranial clinical benefit (CR, PR or SD) for brain metastases at Month 3 (± 4 weeks) will be summarized
The real-world intracranial clinical benefit rate (rwICBR) at Month 6
Time frame: 6 months from first dose of dacomitinib
The percentage of patients with real-world intracranial clinical benefit (CR, PR or SD) for brain metastases at Month 6 (± 4 weeks) will be summarized
The real-world intracranial clinical benefit rate (rwICBR) at Month 12
Time frame: 12 months from first dose of dacomitinib
The percentage of patients with real-world intracranial clinical benefit (CR, PR or SD) for brain metastases at Month 12 (± 4 weeks) will be summarized
The real-world intracranial time to progression (rwICTTP)
Time frame: 30 months from first dose of dacomitinib
The mean and median of the time to the date of the first documentation of real-world progression of intracranial disease.
The real-world systemic overall response rate (rwORR) at Month 3
Time frame: 3 months from first dose of dacomitinib
The number and percentage of patients achieving real-world systemic overall response (CR or PR) for brain metastases at Month 3 (± 4 weeks) will be summarized.
The real-world systemic overall response rate (rwORR) at Month 6.
Time frame: 6 months from first dose of dacomitinib
The number and percentage of patients achieving real-world systemic overall response (CR or PR) for brain metastases at Month 6 (± 4 weeks) will be summarized.
The real-world systemic overall response rate (rwORR) at Month 12.
Time frame: 12 months from first dose of dacomitinib
The number and percentage of patients achieving real-world systemic overall response (CR or PR) for brain metastases at Month 12 (± 4 weeks) will be summarized.
The real-world progression-free survival (rwPFS) during 12 months from index date
Time frame: 12 months from index date
Time to real-world disease progression or death, whichever occurs first, during 12 months from index date will be summarized by the K-M plot with the corresponding 95% CI.
The real-world overall survival (rwOS) during 12 months from index date
Time frame: 12 months from index date
Time to real-world death during 12 months from index date will be summarized by the K-M plot with the corresponding 95% CI.
The real-world overall survival (rwOS) during 24 months from index date
Time frame: 24 months from index date
Time to real-world death during 24 months from index date will be summarized by the K-M plot with the corresponding 95% CI.
5 secondary outcomes
Percentage of patients with dacomitinib treatment discontinuation
Time frame: 30 months from first dose of dacomitinib
Time to dacomitinib treatment discontinuation
Time frame: 30 months from first dose of dacomitinib
Number of patients with dacomitinib dosage change and reasons
Time frame: 30 months from first dose of dacomitinib
Time to dacomitinib dosage change
Time frame: 30 months from first dose of dacomitinib
Concomitant NSCLC-related treatment
Time frame: 30 months from first dose of dacomitinib
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- 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
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Non-Small-Cell Lung, run by Pfizer.
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 6 inclusion and 2 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: withdrawn, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
The real-world intracranial overall response rate (rwICORR) at Month 3 (time frame: 3 months from first dose of dcomitnib). The study lists 13 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 7 Feb 2025.