N/A
Completed N=72
The Study Observes Afatinib as First-line Treatment in Patients With Epidermal Growth Factor Receptor (EGFR) Mutation-positive Advanced Non-small Cell Lung Cancer
Source: ClinicalTrials.gov NCT04206787 ↗Enrolled (actual)
72
Serious AEs
13.9%
Results posted
Feb 2025
Primary outcomePrimary: Time on Treatment of Afatinib as First-line Therapy in Advanced Non-small Cell Lung Cancer Patients With Epidermal Growth Factor Receptor (EGFR) Mutation — 14.4 Months
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time on Treatment of Afatinib as First-line Therapy in Advanced Non-small Cell Lung Cancer Patients With Epidermal Growth Factor Receptor (EGFR) Mutation |
14.4 | — |
| SECONDARY Overall Survival (OS) From the Start of Afatinib Until the End of Study, Date of Death, Patient Withdrawal or Loss to Follow-up |
NA | — |
| SECONDARY Objective Response Rate (ORR) According to Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 by Investigator Review With Afatinib in First-line Treatment |
62.7 | — |
| SECONDARY Number of Patients With Any Adverse Event (AE) |
68 | — |
| SECONDARY Number of Patients With Treatment-emergent Serious Adverse Events (SAE) |
10 | — |
| SECONDARY Number of Patients With Any Afatinib-related Adverse Events (AE) |
63 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04206787). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.