Erlotinib in Post Radical Operation NSCLC Patients With EGFR Mutation

NCT01683175 | Unknown Phase 2

• 1 other identifier: ML28280
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 15

Brief 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.

Conditions

Non-small Cell Lung Cancer Stage III

Keywords

Erlotinib; adjuvant therapy; radical operation; IIIA NSCLC; EGFR mutation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• disease free survival

  5 years

• overall survival (OS)

  5 years

• Quality of Life

  5 years

• Adverse Event (AE)

  5 years

• Serious Adverse Event (SAE)

  5 years

Study Arms (2)

Arm 1

EXPERIMENTAL

Erlotinib 150mg daily oral up to 2 years

Drug: Erlotinib

Arm 2

ACTIVE COMPARATOR

NP Chemotherapy for 4 cycles

Drug: cis-platinum; Drug: Vinorelbine

Interventions

Erlotinib DRUG

Arm 1

cis-platinum DRUG

Arm 2

Vinorelbine DRUG

Arm 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• IIIA NSCLC patients according to TMN-staging of Lung Staging Standard version 7 2009, confirmed by histopathology or cytology after radical operation, and having EGFR exon 19 deletion mutation or exon 21 L858R single base substitution;
• Accept study adjuvant therapy within 6 weeks post radical operation;
• ECOP PS 0-1; Life expectancy ≥12 weeks;
• Hematology: absolute neutrophil count (ANC) ≥1.5×10\^9/L; platelet count ≥100×10\^9/L; hemoglobin concentration ≥ 9.0 g/dL (permit to maintain hematologic criteria by blood transfusion);
• Liver Function: TBil ≤1.5xULN; ALT and AST ≤2.5xULN;
• Renal Function: Cr ≤1.25xULN, and Ccr ≥60ml/min;
• Female patients of childbearing potential must have a negative serum or urine pregnancy test within 7 days before study treatment;
• Signed inform consent form by patient or his/her legal representative;
• Comply with study protocol and procedure, and be able to take oral medication; Aged ≥18 years and ≦75 years;
• Eligible patients of reproductive potential (both sexes) must agree to use a reliable method of birth control before enrollment, during the study period and for at least 30 days after their last dose of study therapy;

You may not qualify if:

• Having treated by Her-Target therapy, i.e. erlotinib, gefitinib, cetuximab, trastuzumab;
• Having treated by any systemic anti-tumor therapy of NSCLC, including cytotoxic therapy, target medication treatment (i.e. monoclonal antibody), investigational therapy;
• Having local radiotherapy of NSCLC; Upper gastrointestinal physiological disorders, or malabsorption syndrome, or intolerance of oral medication, or active peptic ulcer;
• The findings in radical operation are lymph nodes with extracapsular invasion, or fusion, or all of dissection lymph nodes positive by pathology;
• Diagnosed other malignant tumor besides NSCLC within 5 years prior the study treatment (except having simple surgical resection with 5-year disease free survival,cured in situ of cervical carcinoma, cured basal cell carcinoma and bladder epithelial tumor);
• Confirmed recurrent cancer by Clinical objective evidence (pathology or radiography images) before the study adjuvant therapy;
• Known hypersensitivity to platinum, Vinorelbine, EGFR-TKI agents or relevant components in the formulation;
• Uncontrolled eye inflammation or infection, or any potential circumstances lead to eye inflammation or infection;
• Active interstitial lung disease (ILD) by any clinical evidence; patients with any co-morbidities, or motalic disorders, or any abnormal findings in physical examination or laboratory tests are suspected to have contraindication of study therapy or high risk of study treatment complications;
• Any unstable systemic disease, including active infection, uncontrolled hypertension, unstable angina, angina starting in latest 3 months, Congestive heart failure (NYHA ≥ II), myocardial infarction within 6 months prior enrollment, under medication treatment of severe arrhythmia, liver, renal or metabolic disease;
• know HIV infection Pregnant or breastfeeding women;
• ECOG PS ≥2;
• Mixed with small cell lung cancer;
• Other conditions investigators evaluate that patient is not eligible to this study.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead
• Roche Pharma AG: collaborator

Study Sites (15)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

Beijing Cancer Hospital

Beijing, China

Location

Chinese PLA General Hospital

Beijing, China

Location

The second people's hospital of Sichuan

Chengdu, China

Location

Fujian Medical University Union Hospital

Fuzhou, China

Location

Sun Yat-Sen University Cancer Center

Guangzhou, China

Location

Zhejiang Cancer Hospital

Hangzhou, China

Location

The third affiliated hospital of Harbin Medical Univer

Harbin, China

Location

The affiliated hospital of medical college Qingdao University

Qingdao, China

Location

Fudan University Shanghai Cancer Center

Shanghai, China

Location

Zhongshan Hospital Fudan University

Shanghai, China

Location

Liaoning Cancer Hospital & Institute

Shenyang, China

Location

Hebei Provincial Tumor Hospital

Shijiazhuang, China

Location

The first affiliated hospital of Soochow University

Suzhou, China

Location

The fourth military medical university，Tangdu Hospital

Xi'an, China

Location

Related Publications (3)

• 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.

  PMID: 40421698 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, 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.

  PMID: 36027483 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.

  PMID: 30150014 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Erlotinib Hydrochloride; Cisplatin; Vinorelbine

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines

Study Officials

• Changli Wang

  Tianjin Medical University Cancer Institute and Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2012
• First Posted: September 11, 2012
• Study Start: August 1, 2012
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: October 20, 2016

Record last verified: 2016-10

Locations

CN (15)