Clinical trial · Observational
Dacomitinib Treatment Followed by 3rd Generation EGFR-TKI in Patients With EGFR Mutation Positive Advanced NSCLC
Real-world Study on Sequential Therapy With Dacomitinib as First-line Treatment Followed by 3rd Generation EGFR-TKI in Patients With EGFR Mutation Positive Advanced Non-Small Cell Lung Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a non-interventional, multi-center, ambispective cohort study in real world to describe the effectiveness and safety profile in patients with EGFR mutation-positive advanced NSCLC treated with dacomitinib (Vizimpro®) as the first-line treatment followed by 3rd generation EGFR-TKI in case the T790M resistance mutation was developed.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| EGFR Activating Mutation | — | UNRESOLVED | — |
| NSCLC, Recurrent | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| NSCLC Stage IIIB | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| NSCLC Stage IV | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dacomitinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- dacomitinib treatment
- description
- Sequential Therapy with Dacomitinib as First-line Treatment Followed by 3rd generation EGFR-TKI in Patients with EGFR Mutation Positive Advanced Non-Small Cell Lung Cancer
- interventionNames
- Drug: Dacomitinib
Primary outcomes (1)
- measure
- time to treatment failure
- timeFrame
- up to 4 years
- description
- To describe the time to treatment failure (TTF) of sequential dacomitinib and 3rd generation EGFR-TKI used in patients with EGFR mutation-positive NSCLC and T790M-aquired resistance in China.
Secondary outcomes (3)
- measure
- progression-free survival
- timeFrame
- up to 4 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * A confirmed diagnosis of locally advanced or metastatic NSCLC. * The tumor harbored common EGFR mutations (Del19, L858R) at start of first-line treatment * Age ≥ 18 years * Had never received any EGFR TKI therapy. * Patients that treated with dacomitinib (Vizimpro®) as first-line treatment * Confirmation of the T790M variant after first line dacomitinib treatment and receive any 3rd generation EGFR-TKI as second-line treatment. * Asymptomatic CNS metastases allowed * At least one lesion that can be accurately measured at baseline according to the RECIST 1.1, and which is suitable for accurate repeated measurements. * Start second-line treatment with third generation EGFR TKI no later than 01 JAN2023（\>10 month before data cutoff date） * All eligible patients are required to sign an informed consent before initiating the study Exclusion Criteria: * Patients who received drug(s) other than 3rd generation EGFR-TKI as the second-line treatment and/or patients who received drug(s) other than Dacomitinib (Vizimpro®) as the first-line treatment * Received or currently receiving dacomitinib from any interventional clinical trial
References
Publications (0)
Data not yet available