drugset / Trial / NCT01683175
Erlotinib in Post Radical Operation NSCLC Patients With EGFR Mutation
Phase 2
Unknown
94 enrolled
Tianjin Medical University Cancer Institute and Hospital
Roche Pharma AG · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This study is to compare 2-year Disease Free Survival Rate (DFSR) in post radical operation IIIA Non-Small Cell Lung Cancer (NSCLC) patients with Epidermal Growth Factor Receptor (EGFR) 19 or 21 exon mutation treated Erlotinib vs NP chemotherapy as adjuvant therapy.
Timeline
- Start
- 2012-08
- Primary completion
- 2020-10
- Completion
- 2020-10
Publications
- Occhipinti M, Imbimbo M, Ferrara R, Simeon V, Fiscon G, Marchal C, Skoetz N, Viscardi G. Adjuvant epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) for the treatment of people with resected stage I to III non-small-cell lung cancer and EGFR mutation. Cochrane Database Syst Rev. 2025 May 27;5(5):CD015140. doi: 10.1002/14651858.CD015140.pub2.
- Yue D, Xu S, Wang Q, Li X, Shen Y, Zhao H, Chen C, Mao W, Liu W, Liu J, Zhang L, Ma H, Li Q, Yang Y, Liu Y, Chen H, Zhang Z, Zhang B, Wang C. Updated Overall Survival and Exploratory Analysis From Randomized, Phase II EVAN Study of Erlotinib Versus Vinorelbine Plus Cisplatin Adjuvant Therapy in Stage IIIA Epidermal Growth Factor Receptor+ Non-Small-Cell Lung Cancer. J Clin Oncol. 2022 Dec 1;40(34):3912-3917. doi: 10.1200/JCO.22.00428. Epub 2022 Aug 26.
- Yue D, Xu S, Wang Q, Li X, Shen Y, Zhao H, Chen C, Mao W, Liu W, Liu J, Zhang L, Ma H, Li Q, Yang Y, Liu Y, Chen H, Wang C. Erlotinib versus vinorelbine plus cisplatin as adjuvant therapy in Chinese patients with stage IIIA EGFR mutation-positive non-small-cell lung cancer (EVAN): a randomised, open-label, phase 2 trial. Lancet Respir Med. 2018 Nov;6(11):863-873. doi: 10.1016/S2213-2600(18)30277-7. Epub 2018 Aug 24.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cisplatin | Other / unclassified | 75 mg/m2 | Intravenous |
| Subject | Erlotinib | Small molecule | 150 mg | Oral |
| Comparator | Vinorelbine | Small molecule | 25 mg/m2 | Intravenous |