Trial reportThoracic cancer2026
An Observational Study of Afatinib 30 mg Daily in Patients With Advanced Non-Small-Cell Lung Cancer Harboring Common EGFR Mutations Treated With Afatinib.
Trial report in Thoracic cancer, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04909073 (An Observational Study of Afatinib 30 mg Daily in Patients With Advanced Non-small Cell Lung Cancer), which is not on this map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
An Observational Study of Afatinib 30 mg Daily in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) Harbouring Common EGFR Mutations Treated With Afatinib
Who cites it
0 citing papers in PubMed.
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Corrections and comments
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Authors and funding
7 authors.
Funding
Abstract
backgroundAfatinib is an approved first-line treatment for advanced non-small-cell lung cancer (NSCLC) harboring sensitizing EGFR mutations. At the standard 40 mg dose, 28%-53% of patients in randomized trials required dose reductions due to adverse events (AEs), predominantly cutaneous and gastrointestinal. This study evaluated whether a 30 mg starting dose could improve tolerability without compromising efficacy.
methodsThis multicenter, single-arm phase 2 study enrolled treatment-naive patients with advanced EGFR-mutant NSCLC. Patients received afatinib 30 mg daily until progression or unacceptable toxicity. The primary endpoint was 6-month progression-free survival (PFS) rate. Secondary endpoints included median PFS, time-to-treatment failure (TTF), objective response rate (ORR), disease control rate (DCR), and safety. Using A'Hern's single-stage design (one-sided α = 0.1, 80% power), 62 patients were required to distinguish a target 6-month of PFS ≥ 75% from ≤ 62%.
resultsThe study was terminated early due to slow accrual; 30 patients were enrolled between May 2023 and May 2024. Median follow-up was 11.3 months (IQR 9.6-15.5). The 6-month PFS rate was 93.2% (95% CI 75.5-98.3), median PFS of 15.8 months (95% CI 13.4-not reached) and median TTF of 17.0 months. ORR was 80% and DCR 96.7%. Common treatment-related AEs included diarrhea (83.3%), mucositis (60.0%), paronychia (60.0%), and acneiform rash (46.7%). Grade ≥ 3 AEs occurred in 10.0% of patients, with no Grade 4-5 events. Dose modification was required in 13.3% of patients.
conclusionAfatinib 30 mg daily was well tolerated and demonstrated encouraging efficacy, with a 6-month PFS of 93.2%, suggesting outcomes comparable to standard dosing.
trial registrationRegistration number: NCT04909073; https://clinicaltrials.gov.
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