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A Randomized Controlled Trial Comparing Safety and Efficacy of Carboplatin and Paclitaxel Plus or Minus Sorafenib (BAY43-9006) in Chemonaive Patients With Stage IIIB-IV Non-Small Cell Lung Cancer (NSCLC)

Phase 3
18 Years
Not Enrolling
Carcinoma, Non-Small-Cell Lung

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Trial Information

A Randomized Controlled Trial Comparing Safety and Efficacy of Carboplatin and Paclitaxel Plus or Minus Sorafenib (BAY43-9006) in Chemonaive Patients With Stage IIIB-IV Non-Small Cell Lung Cancer (NSCLC)

The study was terminated early when the results from Study 11961 (NCT00300885), an earlier
Phase 3 study evaluating the effects of Sorafenib in combination with paclitaxel and
carboplatin in subjects with advanced NSCLC, showed an overall lack of efficacy of Sorafenib
in combination with paclitaxel and carboplatin in NSCLC and increased mortality in subjects
with squamous subtype.

Inclusion Criteria:

- Stage IIIB (with cytologically confirmed malignant pleural or pericardial effusion)
or Stage IV histological or cytological confirmation of NSCLC (thoracentesis or
pericardiocentesis is not necessary if a biopsy of the original tumor is available to
confirm diagnosis of NSCLC)

- Patients must have measurable disease according to response evaluation criteria in
solid tumors (RECIST) criteria

- Prior local radiotherapy is allowed if it is completed at least 3 weeks prior to the
first dose of study drug, but the lesion which undergo RECIST assessment should not
be in the field of the prior radiation

- Prior surgery is allowed if it is performed at least 4 weeks prior to the first dose
of study drug

- 18 years and above

- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

- Life expectancy of at least 12 weeks

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

- Hemoglobin 9.0 g/dl

- Absolute neutrophil count (ANC) 1,500/mm3

- Platelet count 100,000/mm3

- Total bilirubin < 1.5 times the upper limit of normal

- alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 x upper
limit of normal (< 5 x upper limit of normal for patients with liver involvement)

- international normalized ratio (INR) < 1.5 and activated or adjusted partial
thromboplastin time (APTT) within normal limits (1.2 times the lower limit of normal
(LLN) to 1.2 times the upper limit of normal (ULN))

- Creatinine
- Ability to understand and the willingness to sign a written informed consent. A
signed informed consent must be obtained prior to any study specific procedures

Exclusion Criteria:

- Any prior systemic anticancer therapy including cytotoxic therapy, targeted agents,
experimental therapy, adjuvant, or neo-adjuvant therapy for any current or prior
diagnosis of NSCLC

- Cardiac disease: Congestive heart failure > class II New York Heart Association
(NYHA). Patients must not have unstable angina (anginal symptoms at rest) or
new-onset angina (began within the last 3 months) or myocardial infarction within the
past 6 months

- Known brain metastasis. Patients with neurological symptoms should undergo at
Computed Tomography (CT) scan/Magnetic Resonance Imaging (MRI) of the brain to
exclude brain metastasis

- Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy

- Uncontrolled hypertension defined as systolic blood pressure > 150 mm Hg or diastolic
pressure > 90 mm Hg, despite optimal medical management

- Known human immunodeficiency virus (HIV) infection

- Active clinically serious infections > Common Terminology Criteria for Adverse Events
(CTCAE) Grade 2

- Thrombotic or embolic events such as cerebrovascular accident including transient
ischemic attacks within the past 6 months

- Pulmonary hemorrhage/bleeding event > CTCAE Grade 2 within 4 weeks of first dose of
study drug

- Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first dose of
study drug

- Serious, non-healing wound, ulcer, or bone fracture

- Evidence or history of bleeding diathesis or coagulopathy

- Major surgery, open biopsy or significant traumatic injury within 4 weeks of first
dose of study drug

- Therapeutic anticoagulation with vitamin K antagonists such as warfarin, or with
heparins or heparinoids. Low dose warfarin (1 mg daily, oral) is permitted if the
INR remains < 1.5. Low-dose aspirin is permitted

- Known or suspected allergy to sorafenib or any agent given in the course of this

- Cancer other than NSCLC within 5 years prior to start of study treatment, EXCEPT
cervical cancer in-situ, treated basal cell carcinoma, or superficial bladder tumors

- Concurrent cancer that is distinct in primary site or histology from NSCLC

- Substance abuse, medical, psychological or social conditions that may interfere with
the patients participation in the study or evaluation of the study results

- Any condition that impairs patients ability to swallow whole pills

- Any malabsorption condition

- Women of childbearing potential must have a negative serum pregnancy test performed
within 7 days prior to the start of treatment

- Women of childbearing potential and men must agree to use adequate contraception
prior to study entry and for the duration of study participation, including the 30
days period after last study drug dosing. The investigator should advise the patient
how to achieve an adequate contraception

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival

Outcome Description:

Progression free survival (PFS) is the time (days) from date of randomization to date of first observed disease progression (radiological or clinical, whichever was earlier) or death due to any cause, if death occurred before progression was documented. Since the study was terminated early and 89% of subjects' data were censored, only the number of PFS events (Failed [progressed or died before progression]) is reported, not the usual measure "number of days".

Outcome Time Frame:

Up to 5 months after randomization of the first patient

Safety Issue:


Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:



China: Food and Drug Administration

Study ID:




Start Date:

September 2007

Completion Date:

May 2008

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms