Clinical trial · Observational
The Study Observes Afatinib as First-line Treatment in Patients With Epidermal Growth Factor Receptor (EGFR) Mutation-positive Advanced Non-small Cell Lung Cancer
Real-world Study on Afatinib as First-line Treatment in Patients With Epidermal Growth Factor Receptor (EGFR) Mutation-positive Advanced Non-small Cell Lung Cancer (NSCLC)
- 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 study aims to observe the sequential strategy with afatinib as first-line treatment and to find the optimal treatment strategy for long-term chemotherapy-free regimens in Chinese patients with EGFR-mutated advanced NSCLC. Furthermore, this study can also assess the effectiveness and safety of afatinib as first-line treatment.
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 |
|---|---|---|---|
| Non-squamous, Non-Small Cell Lung Cancer | Lung Non-Squamous Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Afatinib | Drug | Afatinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Afatinib-treated patients
- description
- Chinese patients with epidermal growth factor receptor (EGFR) mutation-positive advanced non-small cell lung cancer who initiated afatinib as first-line treatment. Patients received either 30 milligrams (mg) or 40 mg tablet of afatinib once daily as indicated in the approved label for the drug or any other subsequent therapy.
- interventionNames
- Drug: Afatinib
Primary outcomes (1)
- measure
- Time on Treatment of Afatinib as First-line Therapy in Advanced Non-small Cell Lung Cancer Patients With Epidermal Growth Factor Receptor (EGFR) Mutation
- timeFrame
- From first afatinib administration until last first-line afatinib administration, censoring date or death. Up to approximately 40 months.
- description
- Time on Treatment (TOT) is defined as the median time a patient is under first-line afatinib treatment before being treated with third generation EGFR tyrosine kinase inhibitors (TKI) or other subsequent treatment, starting from the first dose of afatinib treatment until the last first-line dose or death by any cause, whichever comes first. Patients that were lost to follow up, withdrew before the end of study or received first-line afatinib at the end of the study were censored at the time of last known contact of first line afatinib. The median TOT was calculated using the Kaplan Mayer method and the 90% confidence interval was calculated using the Brookmeyer-Crowley method.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients who are diagnosed with locally advanced or metastatic NSCLC with EGFR sensitive mutation positive * Patients who will initiate afatinib as first-line treatment for EGFR mutation-positive NSCLC * Male and female patients with age ≥18 years * Written informed consent per local regulatory requirement Exclusion Criteria: * Patients who have received previous systemic therapy (previous adjuvant or neoadjuvant therapies are permitted) * Patients with symptomatic brain metastases (patients with brain metastases, who were previously treated, are eligible provided they have asymptomatic brain metastasis for at least 4 weeks on stable doses of medication) at the start of afatinib treatment * Patients with concurrent participation in an interventional oncology clinical trial during the first-line treatment phase or within the last 30 days prior to the first-line treatment phase. If patients join another interventional study during the period of second-line treatment or later-line treatment, this patient should not be excluded from this study
References
Publications (0)
Data not yet available