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A Phase II Study of Sorafenib (BAY 43-9006®) in Patients With Relapsed Advanced Non-Small Cell Lung Cancer(NSCLC) After Failure of Epidermal Growth Factor Receptor-tyrosine Kinase Inhibitor (EGFR-TKI)Treatment

Phase 2
18 Years
Not Enrolling
Non-Small Cell Lung Cancer

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Trial Information

A Phase II Study of Sorafenib (BAY 43-9006®) in Patients With Relapsed Advanced Non-Small Cell Lung Cancer(NSCLC) After Failure of Epidermal Growth Factor Receptor-tyrosine Kinase Inhibitor (EGFR-TKI)Treatment

Sorafenib, an oral multi-kinase inhibitor, targets the Raf/MEK/ERK pathway at the level of
Raf kinase and VEGF receptor tyrosine kinases, and has shown efficacy against NSCLC in Phase
I/II trials. Because the targets of sorafenib are different from that of EGFR-TKI, it is
reasonable for sorafenib to treat relapsed advanced NSCLC after failure of EGFR-TKI

Inclusion Criteria:

- Histological or cytological documented stage IIIB (not amenable for radical regional
therapy) or stage IV NSCLC. The pathological diagnosis must be adenocarcinoma with or
without bronchioalveolar carcinoma. Sputum cytology alone is excluded.

- Recurrent or progressive disease after prior one EGFR-TKI treatment. The patient must
have stopped the EGFR-TKI treatment for at least two weeks. The response to EGFR-TKI
should be partial response or complete response or stable disease (the duration of
stable disease should be more than 3 months). Patients who had never received
chemotherapy or received one regimen chemotherapy before EGFR-TKI are eligible.

- Prior surgery, including palliative surgery, is permitted if performed 4 weeks before
the start of study treatment and the patient is fully recovered.

- Prior localized radiotherapy 4 weeks before the start of study is permitted if it was
not administered to target lesions selected for this study, unless progression of the
selected target lesions within the radiation portal is documented. Patient has
recovered from CTCAE grade 3/4 toxicity of radiotherapy. Palliative radiotherapy
within 4 weeks of start of study is also permitted.

- Age > 18 years.

- ECOG Performance Status of 0, 1,or 2. Life expectancy of at least 3 months.
Measurable disease, according to the RECIST, the presence of at least one
uni-dimensional measurable lesion with longest diameter > 20 mm by conventional
techniques or > 10 mm by spiral CT scan.

- Adequate bone marrow, liver and renal function as assessed by the following
laboratory requirements to be conducted within 7 days prior to screening:

- Hemoglobin > 9.0 g/dl

- Platelet count > 75x109/L

- Total bilirubin ≤ 1.5 x upper limit of normal

- ALT and AST < 2.5 x upper limit of normal without liver metastasis, ALT and AST < 5 x
upper limit of normal with liver metastasis.

- International normalized ratio (INR) ≤ 1.5 x the upper limit of normal and
prothrombin time (PT) ≤ 1.5 x the upper limit of normal. Patients who are being
therapeutically anticoagulated with an agent such as Coumadin or heparin will be
allowed to participate provided that no prior evidence of underlying abnormality in
these parameters exists.

- Serum creatinine < 1.5 x upper limit of normal.

Exclusion Criteria:

- Patients who are currently enrolled in, are eligible for, or have access to, any
other sorafenib clinical trial.

- Mixed small cell and non-small cell lung cancer histology. Other pathological types
of NSCLC than adenocarcinoma and bronchioloalveolar cell carcinoma.

- Failure of EGFR-TKI is due to toxicity.

- Prior with exposure to biotherapy, immunotherapy within 4 weeks of study entry.

- Prior exposure to sorafenib or other agents targeting the Ras/MARK pathway or VEGFR.

- Any unresolved toxicity more than CTCAE grade 2 from previous anti-cancer therapy.

- Patients with cardiac arrhythmias greater than grade 1 NCI CTCAE, Version
3.0(Conduction abnormality and supraventricular arrhythmia present but patient is
asymptomatic; intervention not indicated, palpitations present and QTC > 0.45-0.47
second); however, patients with grade 2 atrial fibrillation may be included.

- Significant cardiovascular event: congestive heart failure > NYHA class 2; unstable
angina, active CAD (myocardial infarction more than 6 months prior to study entry is
allowed); serious cardiac arrhythmia requiring anti-arrythmic therapy (beta blockers
or digoxin are permitted) or uncontrolled hypertension.

- Any disease, metabolic dysfunction, physical examination finding, or clinical
laboratory finding giving reasonable suspicion of a disease or condition that
contraindicates the use of any study medication (sorafenib) or that might affect the
interpretation of the results or render the subject at high risk from treatment.

- Central nervous system (CNS) tumor or metastatic tumor.

- Clinically significant gastrointestinal bleeding within 30 days of study entry.

Type of Study:


Study Design:

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

Outcome Measure:

Disease control rate (CR+PR+SD)

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Wu Yi Long, Professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Guangdong General Hospital


China: Food and Drug Administration

Study ID:




Start Date:

December 2008

Completion Date:

April 2012

Related Keywords:

  • Non-Small Cell Lung Cancer
  • non-small cell lung cancer
  • Sorafenib
  • targeted therapy
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms