Gefitinib Versus Vinorelbine/Platinum as Adjuvant Treatment in Stage II-IIIA(N1-N2) NSCLC With EGFR Mutation
NCT ID: NCT01405079
Last Updated: 2020-02-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
222 participants
INTERVENTIONAL
2011-09-19
2020-12-31
Brief Summary
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Detailed Description
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Activating somatic mutations of the tyrosine kinase domain of epidermal growth factor receptor (EGFR) have been characterized in a subset of patients with advanced NSCLC.The EGFR mutation rate was 30% in Chinese NSCLC. Patients harboring these mutations in their tumors show excellent response to EGFR tyrosine kinase inhibitors (EGFR-TKIs). This randomized phase III trial is studying gefitinib to see how well it works compared to cisplatin-based chemotherapy in treating patients who have undergone surgery for stage II-IIIA(N1-N2) NSCLC with EGFR activating mutation in Asian population.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Gefitinib
Gefitinib 250 mg/day oral daily
Gefitinib
Gefitinib 250 mg/day oral daily
Vinorelbine+Cisplatin
Vinorelbine 25 mg/m2 intravenous infusion on day 1 and day 8, Cisplatin 75 mg/m2 on day 1 for 4 cycles
Vinorelbine+Cisplatin
Vinorelbine 25 mg/m2 intravenous infusion on day 1 and day 8, Cisplatin 75 mg/m2 on day 1 for 4 cycles
Interventions
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Gefitinib
Gefitinib 250 mg/day oral daily
Vinorelbine+Cisplatin
Vinorelbine 25 mg/m2 intravenous infusion on day 1 and day 8, Cisplatin 75 mg/m2 on day 1 for 4 cycles
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Males or females aged ≥18 years, \< 75 years.
* Able to comply with the required protocol and follow-up procedures, and able to receive oral medications.
* Target population is completely resected pathological stage II-IIIA(N1-N2) NSCLC with EGFR exon 19 deletions and exon 21 L858R activating mutation.
* Patient who can start the investigational therapy within 3-6 weeks after the complete resection
* ECOG performance status 0-1.
* Life expectancy ≥12 weeks.
* Adequate hematological function: Absolute neutrophil count (ANC) ≥2.0 x 109/L, and Platelet count ≥100 x 109/L, and Hemoglobin ≥9 g/dL (may be transfused to maintain or exceed this level).
* Adequate liver function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN), Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 x ULN in subjects without liver metastases; ≤ 5 x ULN in subjects with liver metastases.
* Adequate renal function: Serum creatinine ≤ 1.25 x ULN, or ≥ 60 ml/min.
* Female subjects should not be pregnant or breast-feeding.
Exclusion Criteria
* Known severe hypersensitivity to pre-medications required for treatment with cisplatin / vinorelbine doublet chemotherapy.
* Inability to comply with protocol or study procedures.
* A serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study.
* A serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease.
* Interstitial pneumonia.
* Patients with prior exposure to agents directed at the HER axis (e.g. erlotinib, gefitinib, cetuximab, trastuzumab).
* Patients with prior chemotherapy or therapy with systemic anti-tumour therapy (e.g. monoclonal antibody therapy).
* Patients with prior radiotherapy
* History of another malignancy in the last 5 years with the exception of the following:Other malignancies cured by surgery alone and having a continuous disease-free interval of 5 years are permitted. Cured basal cell carcinoma of the skin and cured in situ carcinoma of the uterine cervix are permitted.
* Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).
* Eye inflammation or eye infection not fully treated or conditions predisposing the subject to this.
* Evidence of any other disease, neurological or metabolic dysfunction, physical examination or laboratory finding giving reasonable suspicion of a disease or condition that contraindicated the use of an investigational drug or puts the subject at high risk for treatment-related complications.
* Patient who has active serious infection (e.g. pyrexia of or 38.0℃ over)
* Patients who harbouring exon 20 T790M mutation.
18 Years
75 Years
ALL
No
Sponsors
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Guangdong Provincial People's Hospital
OTHER
First Affiliated Hospital, Sun Yat-Sen University
OTHER
Sun Yat-sen University
OTHER
Jilin Provincial Tumor Hospital
OTHER
Liaoning Cancer Hospital & Institute
OTHER
First Hospital of China Medical University
OTHER
Chinese PLA General Hospital
OTHER
Peking Union Medical College Hospital
OTHER
Peking University People's Hospital
OTHER
Beijing Chest Hospital
OTHER
309th Hospital of Chinese People's Liberation Army
OTHER
Peking University Cancer Hospital & Institute
OTHER
Peking University First Hospital
OTHER
Tianjin Medical University Cancer Institute and Hospital
OTHER
The Affiliated Hospital of Qingdao University
OTHER
Jiangsu Cancer Institute & Hospital
OTHER
The First Affiliated Hospital of Soochow University
OTHER
Fudan University
OTHER
Shanghai Pulmonary Hospital, Shanghai, China
OTHER
Zhejiang Cancer Hospital
OTHER
Zhejiang University
OTHER
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER
Tongji Hospital
OTHER
West China Hospital
OTHER
Tang-Du Hospital
OTHER
Guangdong Association of Clinical Trials
OTHER
Responsible Party
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Yi-Long Wu
Dr
Principal Investigators
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Yi-Long WU, MD
Role: PRINCIPAL_INVESTIGATOR
Guangdong Provincial People's Hospital
Xue-Ning YANG, MD
Role: STUDY_CHAIR
Guangdong Provincial People's Hospital
Wen-Zhao ZHONG, MD
Role: STUDY_DIRECTOR
Guangdong Provincial People's Hospital
Locations
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Guangdong General Hospital
Guangzhou, , China
Countries
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References
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Janjigian YY, Park BJ, Zakowski MF, Ladanyi M, Pao W, D'Angelo SP, Kris MG, Shen R, Zheng J, Azzoli CG. Impact on disease-free survival of adjuvant erlotinib or gefitinib in patients with resected lung adenocarcinomas that harbor EGFR mutations. J Thorac Oncol. 2011 Mar;6(3):569-75. doi: 10.1097/JTO.0b013e318202bffe.
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.
Zhong WZ, Wang Q, Mao WM, Xu ST, Wu L, Wei YC, Liu YY, Chen C, Cheng Y, Yin R, Yang F, Ren SX, Li XF, Li J, Huang C, Liu ZD, Xu S, Chen KN, Xu SD, Liu LX, Yu P, Wang BH, Ma HT, Yang JJ, Yan HH, Yang XN, Liu SY, Zhou Q, Wu YL. Gefitinib Versus Vinorelbine Plus Cisplatin as Adjuvant Treatment for Stage II-IIIA (N1-N2) EGFR-Mutant NSCLC: Final Overall Survival Analysis of CTONG1104 Phase III Trial. J Clin Oncol. 2021 Mar 1;39(7):713-722. doi: 10.1200/JCO.20.01820. Epub 2020 Dec 17.
Zhong WZ, Wang Q, Mao WM, Xu ST, Wu L, Shen Y, Liu YY, Chen C, Cheng Y, Xu L, Wang J, Fei K, Li XF, Li J, Huang C, Liu ZD, Xu S, Chen KN, Xu SD, Liu LX, Yu P, Wang BH, Ma HT, Yan HH, Yang XN, Zhou Q, Wu YL; ADJUVANT investigators. Gefitinib versus vinorelbine plus cisplatin as adjuvant treatment for stage II-IIIA (N1-N2) EGFR-mutant NSCLC (ADJUVANT/CTONG1104): a randomised, open-label, phase 3 study. Lancet Oncol. 2018 Jan;19(1):139-148. doi: 10.1016/S1470-2045(17)30729-5. Epub 2017 Nov 21.
Other Identifiers
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CTONG 1104
Identifier Type: OTHER
Identifier Source: secondary_id
CTONG 1104
Identifier Type: -
Identifier Source: org_study_id
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