N/A
Completed N=805
Non-interventional Study for Real-world Data of Afatinib Treatment in First-line Setting and of Subsequent Therapies for Patients With Advanced Epidermal Growth Factor Receptor (EGFR) Mutation-positive Lung Adenocarcinoma
Source: ClinicalTrials.gov NCT04795245 ↗Enrolled (actual)
805
Serious AEs
1.0%
Results posted
Dec 2024
Primary outcomePrimary: Time on Treatment (TOT) With Afatinib in First-line TOT (TOT1) — 0.39; 0.15 Proportion of participants
Summary
The primary objective is to confirm Time on Treatment (TOT) related to afatinib treatment as first-line therapy in patients with Epidermal Growth Factor Receptor (EGFR) mutation-positive Non-Small Cell Lung Cancer (NSCLC).
The observation in the real-world setting of the time from the start of the first-line afatinib until the end of subsequent treatment in this study will provide insights on the sequence of treatment for patients. The Japanese healthcare system will enable this study to evaluate multiple treatment options after afatinib treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time on Treatment (TOT) With Afatinib in First-line TOT (TOT1) |
0.39; 0.15 | — |
| SECONDARY Time on Treatment From the Start of Afatinib Until End of Subsequent Therapies in the Second-line Setting or Death by Any Cause (TOT) |
0.58; 0.30 | — |
| SECONDARY Time on Treatment From Start of the Second-line Treatment Until End of the Second-line Treatment or Death by Any Cause (TOT2) |
0.17; 0.09 | — |
| SECONDARY Overall Survival |
0.80; 0.54 | — |
| SECONDARY Time to Initial Dose Reduction of Afatinib |
0.22; 0.20 | — |
| SECONDARY Percentage of Participants With Dose Modifications of Afatinib |
73.7 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with Epidermal Growth Factor Receptor (EGFR) mutation-positive advanced Non-Small Cell Lung Cancer (NSCLC)
- Patients who were/are treated with afatinib in the first-line setting at least 20 months* prior to data entry
- Patients 20 years of age or older at the time of consent
- Patients who provided consent to participate in this study (for cases of death or lost to follow-up, instructions from the Ethic Committee (EC)/Institutional Review Board (IRB) at each site should be followed) * Inclusion will be restricted to patients with treatment initiation with afatinib at least 20 months prior to enrolment to avoid early censoring.
Exclusion Criteria
- Any contraindication to afatinib as specified in the label of Giotrif®
- Patients treated with afatinib within an interventional trial
- Patients with active brain metastases at start of afatinib treatment* * Patients with non-active brain metastases (asymptomatic state) are eligible.
Data sourced from ClinicalTrials.gov (NCT04795245). 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.