Erlotinib in Post Radical Operation NSCLC Patients With EGFR Mutation

Non-small Cell Lung Cancer Stage III Clinical Trial

Official title:

A Prospective, Open-labelled, Randomized, Multicenter Phase II Study to Evaluate Efficacy and Safety of Erlotinib vs NP Chemotherapy as Adjuvant Therapy in Post Radical Operation NSCLC Patients With EGFR19 or 21 Exon Mutation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01683175
• Other study ID #: ML28280
• Status: Active, not recruiting
• Phase: Phase 2
• First received: August 30, 2012
• Last updated: October 19, 2016
• Start date: August 2012
• Est. completion date: October 2020

Study information

• Verified date: October 2016
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug AdministrationChina: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 94
• Est. completion date: October 2020
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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;

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-small Cell Lung Cancer Stage III

Intervention

Drug:
• Erlotinib

• cis-platinum

• Vinorelbine

Locations

Country	Name	City	State
China	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	Tianjin Medical University Cancer Institute and Hospital	Tianjin	Tianjin
China	The fourth military medical university,Tangdu Hospital	Xi'an

Sponsors (2)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and Hospital	Roche Pharma AG

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	disease free survival	Disease free survival is defined as the time from randomization to disease recurrence or death which comes first.	5 years	No
Secondary	overall survival (OS)	Overall survival is defined as the time from randomization to death.	5 years	No
Secondary	Quality of Life	The score of Functional Assessment of Cancer Therapy - Lung (FACT-L) subscale and Lung Cancer Symptom Scale (LCSS)	5 years	No
Secondary	Adverse Event (AE)	frequency of Adverse Event	5 years	Yes
Secondary	Serious Adverse Event (SAE)	Frequency of Serious Adverse Event (SAE)	5 years	Yes