Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Roche Pharma AG | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Erlotinib 150mg daily oral up to 2 years |
|
| Arm 2 | Active Comparator | NP Chemotherapy for 4 cycles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erlotinib | Drug |
| ||
| cis-platinum |
| Measure | Description | Time Frame |
|---|---|---|
| 2-year disease free survival rate (DFSR) | 2-year disease free survival rate is defined as the estimation percentage of disease free survival patients with study treatment at 2-year. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| disease free survival | Disease free survival is defined as the time from randomization to disease recurrence or death which comes first. | 5 years |
| overall survival (OS) | Overall survival is defined as the time from randomization to death. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Changli Wang | Tianjin Medical University Cancer Institute and Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University Cancer Institute and Hospital | Tianjin | Tianjin Municipality | 300060 | China | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40421698 | Derived | 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. | |
| 36027483 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Vinorelbine | Drug |
|
| 5 years |
| Quality of Life | The score of Functional Assessment of Cancer Therapy - Lung (FACT-L) subscale and Lung Cancer Symptom Scale (LCSS) | 5 years |
| Adverse Event (AE) | frequency of Adverse Event | 5 years |
| Serious Adverse Event (SAE) | Frequency of Serious Adverse Event (SAE) | 5 years |
| Beijing Cancer Hospital |
| Beijing |
| China |
| Chinese PLA General Hospital | Beijing | China |
| The second people's hospital of Sichuan | Chengdu | China |
| Fujian Medical University Union Hospital | Fuzhou | China |
| Sun Yat-Sen University Cancer Center | Guangzhou | China |
| Zhejiang Cancer Hospital | Hangzhou | China |
| The third affiliated hospital of Harbin Medical Univer | Harbin | China |
| The affiliated hospital of medical college Qingdao University | Qingdao | China |
| Fudan University Shanghai Cancer Center | Shanghai | China |
| Zhongshan Hospital Fudan University | Shanghai | China |
| Liaoning Cancer Hospital & Institute | Shenyang | China |
| Hebei Provincial Tumor Hospital | Shijiazhuang | China |
| The first affiliated hospital of Soochow University | Suzhou | China |
| The fourth military medical university,Tangdu Hospital | Xi'an | China |
| 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. |
| 30150014 | Derived | 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. |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069347 | Erlotinib Hydrochloride |
| D002945 | Cisplatin |
| D000077235 | Vinorelbine |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D007211 | Indoles |
| D054836 | Indolizidines |
| D007212 | Indolizines |
Not provided
Not provided