A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, CONTROLLED PHASE 3, EFFICACY AND SAFETY STUDY OF SUNITINIB (SU011248) IN PATIENTS WITH ADVANCED/METASTATIC NON-SMALL CELL LUNG CANCER TREATED WITH ERLOTINIB - ND

• Conditions: ocally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen.; MedDRA version: 9.1Level: LLTClassification code 10059515Term: Non-small cell lung cancer metastatic

• Registration Number: EUCTR2007-001915-52-IT
• Lead Sponsor: PFIZER

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07-31
• Last Update Posted: 13 May 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 956

Inclusion Criteria

1. Histologically or cytologically proven diagnosis of NSCLC with evidence of disease that is recurrent (after treatment for Stage IIIB with malignant effusion or Stage IV NSCLC) and for which erlotinib treatment is clinically indicated. 2. Prior treatment with 1 or 2 chemotherapy regimens (including a platinum-based regimen) for advanced disease (Stage IIIB with malignant effusion or Stage IV NSCLC). 3. Disease progression during or after first-line chemotherapy 4. Measurable or nonmeasurable disease. 5. Male or female, 18 years of age or older. 6. ECOG performance status 0 or 1. 7. Resolution of all acute toxic effects of prior therapy or surgical procedures to Grade /=3.0 g/dL Absolute neutrophil count (ANC) >/=1500/µL Platelets >/=100,000/µL Hemoglobin >/=9.0 g/dL Serum creatinine Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Prior treatment with any receptor tyrosine kinase inhibitors (including but not limited to sunitinib, erlotinib, and gefitinib), VEGF inhibitors (with the exception of bevacizumab), or other angiogenesis inhibitors (including but not limited to thalidomide) 2. Treatment with sunitinib and/or erlotinib if it is contraindicated according to the local prescribing information. 3. Major surgery within 4 weeks of study treatment. At least 7 days should elapse since minor surgical procedure including placement of an access device or fine needle aspiration. 4. Tumor (any histology) that involves a major blood vessel (no aortic involvement). 5. Major radiation therapy within 4 weeks of study treatment except palliative radiotherapy to non-target metastatic lesions. 6. Systemic anticancer therapy within 4 weeks of starting the study treatment. 7. Prior treatment with a platinum-based regimen as adjuvant therapy following resection for early-stage NSCLC. 8. Prior high-dose chemotherapy requiring hematopoietic stem cell rescue. 9. Prior radiation therapy to >25% of the bone marrow. 10. Evidence of hemoptysis <4 weeks of starting study treatment. Patients with blood-tinged or blood-streaked sputum will be permitted on study if the hemoptysis amounts to less than 5 mL of blood per episode and less than 10 mL of blood per 24-hour period in the best estimate of the Investigator. 11. Presence or history of brain metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease. 12. Diagnosis of any second malignancy within the last 3 years, except for adequately treated basal cell carcinoma or squamous cell skin cancer, or carcinoma in situ of the cervix uteri. 13. Any of the following within the 12 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident including transient ischemic attack, or pulmonary embolism. 14. Ongoing cardiac dysrhythmias of NCI CTCAE grade >/=2, atrial fibrillation of any grade, or QTc interval >450 msec for males or >470 msec for females. 15. Hypertension that cannot be controlled by medications (>150/100 mmHg despite optimal medical therapy). 16. Severe dry eye syndrome, Sjogren's syndrome, severe exposure keratopathy, bullous keratopathy, aniridia, severe chemical burns, neutrophilic keratitis, or clinically significant gastrointestinal abnormalities including uncontrolled inflammatory disease (eg, Crohn's or ulcerative colitis). 17. Known human immunodeficiency virus infection. 18. Current treatment on another clinical trial. 19. Pregnancy or breastfeeding. Female patients, who are pregnant or nursing, or men and women of reproductive potential who are unwilling or unable to use adequate contraception to prevent pregnancy during the program. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to study entry. 20. Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the Investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the Investigator, would make the patient inappropriate for entry into this study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified