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A National, Multi Center, Randomized, Open-label, Phase III Trial of Gefitinib Versus Combination of Vinorelbine Plus Platinum as Adjuvant Treatment in Pathological Stage II-IIIA(N1-N2) Non-small Cell Lung Cancer With Epidermal Growth Factor Receptor Activating Mutation

Phase 3
18 Years
75 Years
Open (Enrolling)
Non-small Cell Lung Cancer

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Trial Information

A National, Multi Center, Randomized, Open-label, Phase III Trial of Gefitinib Versus Combination of Vinorelbine Plus Platinum as Adjuvant Treatment in Pathological Stage II-IIIA(N1-N2) Non-small Cell Lung Cancer With Epidermal Growth Factor Receptor Activating Mutation

Adjuvant cisplatin-based chemotherapy is recommended for routine use in patients with stages
IIA, IIB, and IIIA non-small cell lung cancer (NSCLC) after complete resection. Cisplatin
and vinorelbine combination is the standard of care in adjuvant setting. The BR. 19 trial
reported adjuvant gefitinib after complete resection of early stage NSCLC(stage IB 49%, II
38%, III 13%) did not confer disease free survival(DFS) or overall survival(OS) advantage in
overall population. While the median gefitinib treatment time is only 4.8 months. There are
only 76 patients with EGFR mutations included in this analysis. The study closed prematurely
in 2005.

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.

Inclusion Criteria:

- Written informed consent provided.

- 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

- 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 gefitinib or any of the excipients of this product.

- 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

- 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.

Type of Study:


Study Design:

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

Outcome Measure:

Disease free survival

Outcome Description:

To evaluate the disease free survival of gefitinib versus combination of vinorelbine plus platinum as adjuvant treatment for pathological stage II-IIIA(N1-N2) NSCLC with EGFR mutation.Disease free survival (DFS)- defined as the time from randomization to the first documented disease progression or death, whichever occurs first.

Outcome Time Frame:

Pts after surgery will receive long-term follow-up including chest CT scan, abdominal ultrasound every 3 months, brain MRI every 6 months, bone scan every 12 months for up to 3 years. The survival after 3 years will be followed up with telephone.

Safety Issue:


Principal Investigator

Yi-Long WU, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Guangdong General Hospital


China: Food and Drug Administration

Study ID:

C-TONG 1104



Start Date:

July 2011

Completion Date:

August 2018

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Lung cancer
  • II-IIIA(N1-N2)
  • Adjuvant treatment
  • EGFR mutations
  • Tyrosine kinase inhibitor
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms