An observational study in Carcinoma, Non-Small-Cell Lung, sponsored by Pfizer. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-07.
Sponsored by Pfizer · Observational
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.
6,645 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,665 are open to participants now.
Browse Carcinoma, Non-Small-Cell Lung studies →Pfizer is the lead sponsor of 3,323 studies on the registry; 145 are open to participants now.
Of its 597 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adults with epidermoid growth factor receport (EGFR)-positive non-small cell lung cancer (NSCLC) with brain metastasis
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Drug: dacomitnib
patients with dacomitnib as first line treatment for advanced NSCLC with brain metastasis
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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 24 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 30 months from first dose of dacomitinib
Concomitant NSCLC-related treatment
The number patients with concomitant NSCLC-related treatment will be summarized.
Time frame: 30 months from first dose of dacomitinib
No study locations are listed for this record.
Plan to share: 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.
No publications or documents are linked to this record.
Start is estimated for Sep 2024; primary completion for Sep 2026, 23 months later.
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This study is withdrawn, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung →