Know Cancer

forgot password

A Phase II Trial of Erlotinib Versus Combination of Vinorelbine Plus Cisplatin as Adjuvant Treatment in Stage IIIA Non-small-cell Lung Cancer After Complete Resection With Sensitizing EGFR Mutation in Exon 19 or 21 and Wild-type K-ras

Phase 2
18 Years
70 Years
Open (Enrolling)
Non-small Cell Lung Cancer Stage IIIA

Thank you

Trial Information

A Phase II Trial of Erlotinib Versus Combination of Vinorelbine Plus Cisplatin as Adjuvant Treatment in Stage IIIA Non-small-cell Lung Cancer After Complete Resection With Sensitizing EGFR Mutation in Exon 19 or 21 and Wild-type K-ras

The LACE meta-analysis identified four cycles of platinum-based program to improve II~IIIA
stage completely resected NSCLC pts the role of 5-year survival, but its treatment-related
life threatening toxicity limits its use. The EGFR tyrosine kinase inhibitor (TKI) may
provide a dramatic response in pts with pulmonary adenocarcinoma carrying EGFR activating
mutations in the metastatic setting. The aim of this study is to investigate the efficacy
and safety of erlotinib versus NVB plus cisplatin (NP) as adjuvant treatment in pts with
stage IIIA NSCLC after Complete Resection with EGFR activating mutations and to explore a
new treatment strategy for this subset.

Inclusion Criteria:

- Written informed consent provided.

- Males or females aged ≥18 years.

- Chest CT, brain CT or MRI, ECT, abdominal and double-neck B-, or whole body PET-CT
examination in 4 weeks before complete resection.

- Pathological diagnosed of non-small cell lung cancer.

- Diagnosed as stage IIIA.

- In 4 weeks after complete resection pts start to accept the adjuvant therapy in this
study, previously did not receive any anti-tumor therapy.

- EGFR activating mutation in exon 19 or 21 and KARS

- ECOG performance status 0-1.

- Life expectancy ≥3 months.

- Adequate hematological function:Absolute neutrophil count (ANC) ≥1.5 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.

- Adequate renal function:Serum creatinine ≤ 1.25 x ULN, and creatinine clearance ≥ 60

- Able to comply with the required protocol and follow-up procedures, and able to
receive oral medications.

- Patients must be nonpregnant and non-lactating.Patients of childbearing potential
must implement an effective method of contraception during the study. All female
Patients, except those who are postmenopausal or surgically sterilized, must have a
negative pre-study serum or urine pregnancy test. .

Exclusion Criteria:

- 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.

- Patients with prior radiotherapy.

- History of another malignancy in the last 5 years with the exception of the
following:Cured basal cell carcinoma of the skin and cured in situ carcinoma of the
uterine cervix are permitted.

- Any evidence confirmed tumor recurrence before adjuvant treatment.

- 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

- Any evidence of clinically active interstitial lung disease.

- Eye inflammation or eye infection not fully treated or conditions predisposing the
subject to this.

- Known human immunodeficiency virus (HIV) infection.

- Known hypersensitivity to Tarceva or NVB or cisplatin.

- Pregnancy or breast-feeding women.

- ECOG performance status ≥ 2.

- Ingredients mixed with small cell lung cancer patients

- 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.

Type of Study:


Study Design:

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

Outcome Measure:

Disease-free survival

Outcome Description:

To evaluate Disease-free survival(DFS) of two groups

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: Ethics Committee

Study ID:




Start Date:

May 2011

Completion Date:

July 2017

Related Keywords:

  • Non-small Cell Lung Cancer Stage IIIA
  • EGFR Mutation Positive
  • complete resection
  • Erlotinib Versus NVB/Cisplatin as Adjuvant treatment
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms