Erlotinib and Sorafenib in Chemonaive Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00722969
Recruitment Status : Unknown
Verified March 2009 by Free University Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : July 28, 2008
Last Update Posted : March 3, 2009
Information provided by:
Free University Medical Center

Brief Summary:
Patients with advanced or metastatic (stage IIIB-IV) non small cell lung cancer who have not received prior chemotherapy will be treated with erlotinib 150 mg once a day and sorafenib 400 mg twice a day. The objectives of the study are to assess the efficacy and safety of this combination treatment. Additional exploratory study objectives are correlation of biomarkers and imaging modalities potentially predictive for response and (progression free) survival.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Drug: sorafenib + erlotinib Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Erlotinib and Sorafenib in Patients With Locally Advanced and/or Metastatic (Stage IIIb or IV) Non Small Cell Lung Cancer Who Have Not Received Prior Chemotherapy
Study Start Date : November 2007
Estimated Primary Completion Date : November 2008
Estimated Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: A Drug: sorafenib + erlotinib
sorafenib 400mg b.i.d oral Erlotinib 150 mg o.i.d oral
Other Names:
  • nexavar
  • tarceva

Primary Outcome Measures :
  1. Rate of non-progression at 6 weeks [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Best overall response rate [ Time Frame: end of study ]
  2. Duration of response [ Time Frame: End of study ]
  3. Survival [ Time Frame: End of study ]
  4. Toxicity [ Time Frame: Week 1, week 3, week 6, week 9, week 12 then every 6 weeks ]
  5. Prediction of early response and effects on tumor vascularisation by PET and perfusion CT scans [ Time Frame: Baseline, week 3 and week 6 ]
  6. Biomarkers for response (Proteomics, circulating cells, mutational analysis) [ Time Frame: Baseline, week 1, week 3 and week 6 ]

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Histologically/cytologically advanced NSCLC stage IIIB or IV
  2. No prior chemotherapy or therapy with systemic anti-tumor therapy (e.g., monoclonal antibody therapy) or prior exposure to agents directed at the HER axis (e.g. EGFR TK inhibitors, Herceptin). Prior surgery and/or localized irradiation is permitted provided that the irradiated lesion is not the only measurable lesion.
  3. Age > 18 years.
  4. ECOG Performance Status of 0 or 1
  5. Life expectancy of at least 12 weeks.
  6. Subjects with at least one uni-dimensional(for RECIST) measurable lesion. Lesions must be measured by CT-scan.
  7. Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
  8. Hemoglobin > 9.0 g/dl
  9. Absolute neutrophil count (ANC) >1,500/mm3
  10. Platelet count > 100,000/μl
  11. Total bilirubin < 1.5 times the upper limit of normal
  12. ALT and AST < 2.5 x upper limit of normal (< 5 x upper limit of normal for patients with liver involvement of their cancer)
  13. Alkaline phosphatase < 4 x ULN
  14. PT-INR/PTT < 1.5 x upper limit of normal [Patients who are being therapeutically anticoagulated with low molecular weight heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists.]
  15. Serum creatinine < 1.5 x upper limit of normal.
  16. Written informed consent.

Exclusion Criteria:

Excluded medical conditions:

  1. History of cardiac disease: congestive heart failure >NYHA class 2; active CAD (MI more than 6 mo prior to study entry is allowed); cardiac arrhythmias requiring anti-arrhythmic therapy( beta blockers or digoxin are permitted) or uncontrolled hypertension.
  2. History of HIV infection or chronic hepatitis B or C.
  3. Active clinically serious infections (> grade 2 NCI-CTC version 3.0)
  4. Symptomatic metastatic brain or meningeal tumors (unless the patient is > 1 months from definitive radiotherapy and off steroids):
  5. Patients with seizure disorder requiring medication (such as steroids or anti-epileptics)
  6. History of organ allograft.
  7. Patients with evidence or history of bleeding diathesis
  8. Patients undergoing renal dialysis
  9. Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors [Ta, Tis & T1] or any cancer curatively treated > 3 years prior to study entry.

Excluded therapies and medications, previous and concomitant:

  1. Anticancer chemotherapy or immunotherapy during the study or within 4 weeks of study entry.
  2. Radiotherapy during study or within 3 weeks of start of study drug. (Palliative radiotherapy will be allowed). Major surgery within 3 weeks of start of study
  3. Autologous bone marrow transplant or stem cell rescue within 4 months of study
  4. Use of biologic response modifiers, such as G-CSF, within 3 week of study entry. [G-CSF and other hematopoietic growth factors may be used in the management of acute toxicity such as febrile neutropenia when clinically indicated or at the discretion of the investigator, however they may not be substituted for a required dose reduction.] [Patients taking chronic erythropoietin are permitted provided no dose adjustment is undertaken within 2 months prior to the study or during the study]
  5. Investigational drug therapy outside of this trial during or within 4 weeks of study entry
  6. Prior exposure to the study drugs.
  7. Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial and two weeks after the completion of trial.
  8. Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
  9. Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study
  10. Patients unable to swallow oral medications.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00722969

VU university medical center
Amsterdam, Netherlands, 1007 MB
Netherlands Cancer Institute
Amsterdam, Netherlands
University Medical Center Groningen
Groningen, Netherlands
University Hospital Maastricht
Maastricht, Netherlands
Sponsors and Collaborators
Free University Medical Center
Principal Investigator: Egbert F Smit, Phd, MD VU University Medical Center

Responsible Party: Prof Dr E.F. smit, VU University Medical Center Identifier: NCT00722969     History of Changes
Other Study ID Numbers: 07/203
EudraCT: 2007-004625-14
First Posted: July 28, 2008    Key Record Dates
Last Update Posted: March 3, 2009
Last Verified: March 2009

Keywords provided by Free University Medical Center:
non-small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs