Clinical trial · Observational
A Study to Learn About Dacomitnib in Patients With Non-small Cell Lung Cancer Which Has Spread to the Brain.
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor Decision
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| dacomitnib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- dacomitnib
- interventionNames
- Drug: dacomitnib
Primary outcomes (13)
- measure
- The real-world intracranial overall response rate (rwICORR) at Month 3
- timeFrame
- 3 months from first dose of dcomitnib
- description
- 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.
- measure
- The real-world intracranial overall response rate (rwICORR) at Month 6
- timeFrame
- 6 months from first dose of dacomitnib
- description
- The percentage of patients achieving real-world intracranial overall response (CR or PR) for brain metastases at Month 6 (± 4 weeks) will be summarized.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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) Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available