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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

Phase 2
18 Years
75 Years
Open (Enrolling)
Non-small Cell Lung Cancer Stage III

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Trial Information

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

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 4 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

- 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,

- Having treated by any systemic anti-tumor therapy of NSCLC, including cytotoxic
therapy, target medication treatment (i.e. monoclonal antibody), investigational

- 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.

Type of Study:


Study Design:

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

Outcome Measure:

2-year disease free survival rate (DFSR)

Outcome Description:

2-year disease free survival rate is defined as the estimation percentage of disease free survival patients with study treatment at 2-year.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Changli Wang

Investigator Role:

Principal Investigator

Investigator Affiliation:

Tianjin Medical University Cancer Institute and Hospital


China: Food and Drug Administration

Study ID:




Start Date:

August 2012

Completion Date:

March 2019

Related Keywords:

  • Non-small Cell Lung Cancer Stage III
  • Erlotinib
  • adjuvant therapy
  • radical operation
  • EGFR mutation
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms