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Phase II Study of the Raf Kinase Inhibitor BAY43-9006 in Patients With Advanced Non-Small Cell Lung Cancer

Phase 2
18 Years
Not Enrolling
Recurrent Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer

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Trial Information

Phase II Study of the Raf Kinase Inhibitor BAY43-9006 in Patients With Advanced Non-Small Cell Lung Cancer


I. Determine the response rate in patients with stage IIIB or IV non-small cell lung cancer
treated with sorafenib.

II. Determine the clinical toxic effects of this drug in these patients.


I. Determine the 24-week progression-free survival rate in patients treated with this drug.

II. Determine the overall survival of patients treated with this drug. III. Determine the
time to disease progression in patients treated with this drug.

IV. Correlate predictive disease markers (K-ras and B-raf mutations and ERK/pERK, AKT/pAKT,
and VEGFR2/p-VEGFR2 expression) in these patients with the activity of this drug.

OUTLINE: This is a multicenter study.

Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in
the absence of disease progression or unacceptable toxicity.

Patients are followed every 6 months for up to 5 years.

Inclusion Criteria:

- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC), meeting
1 of the following stage criteria:

- Stage IIIB with pleural effusion

- Stage IV

- Measurable disease

- At least 1 lesion ≥ 2.0 cm by conventional techniques OR ≥ 1.0 cm by spiral CT

- The following are not considered measurable disease:

- Bone lesions

- Leptomeningeal disease

- Ascites

- Pleural/pericardial effusion

- Inflammatory breast disease

- Lymphangitis cutis/pulmonis

- Abdominal masses not confirmed and followed by imaging techniques

- Cystic lesions

- No known brain metastases, even if treated and stable

- Performance status - ECOG 0-2

- At least 12 weeks

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 10 g/dL

- No bleeding diathesis

- Bilirubin ≤ 2 times upper limit of normal (ULN)

- AST ≤ 3 times ULN (5 times ULN if hepatic metastasis present)

- Creatinine ≤ 1.5 times ULN

- No uncontrolled hypertension

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No known HIV positivity

- HIV negative

- Able to swallow tablets

- No uncontrolled infection

- No other severe underlying disease that would preclude study participation

- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer or adequately treated noninvasive carcinomas

- No prior immunotherapy, biologic therapy, or gene therapy

- No concurrent prophylactic colony-stimulating factors

- At least 4 weeks since prior low-dose weekly chemotherapy as a radiosensitizer

- No other prior chemotherapy for NSCLC

- No concurrent chemotherapy

- See Chemotherapy

- At least 4 weeks since prior radiotherapy

- No prior radiotherapy to ≥ 30% of bone marrow

- No concurrent radiotherapy

- Concurrent palliative radiotherapy to nontarget lesions (e.g., painful
pre-existing bony metastasis) allowed

- Prior adjuvant therapy allowed provided recurrent disease occurred > 6 months after
completion of adjuvant therapy

- No prior systemic therapy for NSCLC, including all novel targeted agents (e.g.,
gefitinib or erlotinib)

- No concurrent therapeutic anticoagulation

- Prophylactic anticoagulation (e.g., low-dose warfarin) for venous and arterial
devices allowed provided PT, INR, and PTT requirements are met

- No other concurrent anticancer agents or therapies

- No other concurrent investigational agents or therapies

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Confirmed tumor response according to RECIST criteria

Outcome Description:

The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated using the Duffy-Santner approach.

Outcome Time Frame:

Up to 5 years

Safety Issue:


Principal Investigator

Alex Adjei

Investigator Role:

Principal Investigator

Investigator Affiliation:

North Central Cancer Treatment Group


United States: Food and Drug Administration

Study ID:




Start Date:

December 2004

Completion Date:

Related Keywords:

  • Recurrent Non-Small Cell Lung Cancer
  • Stage IIIB Non-Small Cell Lung Cancer
  • Stage IV Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



North Central Cancer Treatment Group Rochester, Minnesota  55905