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| ID | Type | Description | Link |
|---|---|---|---|
| NCT06075615 | Registry Identifier | ClinicalTrials.gov |
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Sponsor Decision
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dacomitnib |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dacomitnib | Drug | patients with dacomitnib as first line treatment for advanced NSCLC with brain metastasis |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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 | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 months from first dose of dacomitinib |
| Time to dacomitinib treatment discontinuation |
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Inclusion Criteria:
Exclusion Criteria:
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Adults with epidermoid growth factor receport (EGFR)-positive non-small cell lung cancer (NSCLC) with brain metastasis
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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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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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 24 months from index date |
Time to dacomitinib treatment discontinuation during follow-up period will be summarized by the K-M plot with the corresponding 95% CI. |
| 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. | 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. | 30 months from first dose of dacomitinib |
| Concomitant NSCLC-related treatment | The number patients with concomitant NSCLC-related treatment will be summarized. | 30 months from first dose of dacomitinib |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |