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A Phase II Study of Single Agent Sorafenib in Non-small Cell Lung Cancer Patients Who Never Smoked or Were Former Light Smokers.

Phase 2
18 Years
Not Enrolling
Lung Cancer

Thank you

Trial Information

A Phase II Study of Single Agent Sorafenib in Non-small Cell Lung Cancer Patients Who Never Smoked or Were Former Light Smokers.



- To determine the efficacy of sorafenib tosylate, in terms of 6-month progression-free
survival rate, in non-smokers or former light smokers with relapsed or refractory stage
IIIB or IV non-small cell lung cancer.


- To determine the 1-year survival rate in patients treated with this drug.

- To assess the frequency and severity of adverse events associated with this drug in
these patients.

- To investigate the mutational status of EGFR (epidermal growth factor receptor), ALK
(anaplastic lymphoma kinase), ROS1, and K-Ras(Kirsten rat sarcoma viral oncogene
homolog)in archived tumor samples from these patients.

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

Archived tumor tissue samples are analyzed for mutations of EGFR, ALK, ROS1, and K-Ras by
PCR (polymerase chain reaction) and DNA (deoxyribonucleic acid) sequencing.

After completion of study treatment, patients are followed every 3 months.

Inclusion Criteria


- Histologically confirmed non-small cell lung cancer

- Stage IIIB or IV disease

- Recurrent disease after prior surgery, chemotherapy, or radiotherapy

- No squamous cell histology or mixed tumor with > 50% squamous cells

- Non-smoker (smoked ≤ 100 cigarettes in lifetime) OR former light smoker (smoked > 100
cigarettes but ≤ 10 pack years AND quit smoking ≥ 1 year ago)

- No known brain metastasis

- Patients with neurological symptoms must undergo a CT scan or MRI of the brain
to exclude brain metastasis


- ECOG(Eastern Cooperative Oncology Group)performance status 0-2

- ANC (Absolute Neutrophil Count)≥ 1,500/mm³

- Platelet count ≥ 100,000/mm³

- ALT (Alanine Aminotransferase Test) and AST (Aspartate Aminotransferase Test) ≤ 2.5
times upper limit of normal (ULN)

- Alkaline phosphatase ≤ 2.5 times ULN

- Bilirubin ≤ 1.5 mg/dL

- Creatinine clearance ≥ 50 mL/min

- INR (International Normalized Ratio) < 1.5 OR PT/PTT (Prothrombin time/partial
thromboplastin time)normal

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective barrier contraception prior to, during, and for ≥
3 months after completion of study treatment

- No cardiac disease, including any of the following:

- New York Heart Association class III-IV congestive heart failure

- Unstable angina (anginal symptoms at rest)

- New-onset angina within the past 3 months

- Myocardial infarction within the past 6 months

- No cardiac ventricular arrhythmias requiring anti-arrhythmic therapy

- No uncontrolled hypertension (i.e., systolic blood pressure [BP] > 150 mm Hg or
diastolic BP > 90 mm Hg) despite optimal medical management

- No thrombolic or embolic events (e.g., cerebrovascular accident, including transient
ischemic attacks) within the past 6 months

- No pulmonary hemorrhage or bleeding event ≥ CTCAE (Common Terminology Criteria for
Adverse Events)grade 2 within the past 4 weeks

- No other hemorrhage or bleeding event ≥ CTCAE grade 3 within the past 4 weeks

- No active clinically serious infection > CTCAE grade 2

- No serious non-healing wound, ulcer, or bone fracture

- No evidence or history of bleeding diathesis or coagulopathy

- No known HIV infection or chronic hepatitis B or C

- No other malignancy except for any of the following:

- Adequately treated basal cell or squamous cell skin cancer

- In situ cervical cancer

- Other cancer from which the patient has been disease-free for ≥ 5 years with a
low probability of recurrence

- No condition that impairs the patient's ability to swallow whole pills

- No malabsorption problems

- No known or suspected allergy to sorafenib tosylate or any agent given in the course
of this study

- No significant traumatic injury within the past 4 weeks


- See Disease Characteristics

- No more than one prior systemic chemotherapy treatment for metastatic disease

- Prior treatment with EGFR inhibitors is not considered chemotherapy

- More than 4 weeks since prior major surgery or open biopsy

- No prior sorafenib tosylate

- No concurrent St. John's wort or rifampin

- Concurrent anticoagulation with warfarin or heparin allowed

Type of Study:


Study Design:

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

Outcome Measure:

Progression-free survival at 6 months

Outcome Time Frame:


Safety Issue:


Principal Investigator

Miguel A. Villalona, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ohio State University


United States: Institutional Review Board

Study ID:




Start Date:

October 2008

Completion Date:

Related Keywords:

  • Lung Cancer
  • recurrent non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • adenocarcinoma of the lung
  • bronchoalveolar cell lung cancer
  • large cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Ohio State University Columbus, Ohio  43210