A Phase II study of Tarceva in Combination with Avastin versus chemotherapy plus Avastin in 1st line advanced NSCLC patients - ND

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 200

Inclusion Criteria

Age ≥ 18 years Able to comply with the protocol Patients must be able to take oral medication Histologically documented inoperable, locally advanced (stage IIIb with supra-clavicular lymph node metastases or malignant pleural or pericardial effusion), metastatic (stage IV) or recurrent NSCLC (NOTE: Sputum cytology alone is not acceptable). Tumors with mixed histology should be categorized according to the predominant cell type. Formalin fixed paraffin embedded tumor tissue samples representative of the disease and containing sufficient tumor cells (>100 per section) must be available Measurable disease according to RECIST ECOG performance status 0-1 Life expectancy > 12 weeks Adequate hematological function : ANC > 1.5 x 109/L; platelets < 100 x 109/L, Hb > 9 g/dL INR < 1.5 and PTT < 1.5 x ULN within 7 days prior to starting study treatment Adequate liver function: Serum bilirubin < 1.5 x ULN; transaminases < 2.5 x ULN (in case of liver metastases <5 x ULN) Adequate renal function: Creatinine clearance, measured and/or calculated according to the formula of Cockroft and Gault > 60 mL/min AND urine dipstick for proteinuria < 2+. If urine dipstick is > 2+, 24- hour urine must demonstrate < 1 g of protein in 24 hours Normal serum calcium Negative pregnancy test within 7 days of starting study treatment in pre-menopausal women and women < 2 years after the onset of menopause Written informed consent
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

Squamous non-small cell tumors with central pulmonary lesion (a central lung lesion is defined as any lesion meeting the following criteria epicenter of the tumor is > 2 cm from the costal or diaphragmatic pleura in a 3-dimensional orientation based on each lobe of the lung) History of > grade 2 hemoptysis (bright red blood of at least œ teaspoon) Evidence of CNS metastases, even if previously treated. If suspected, the patient should be scanned within 28 days prior to enrolment to rule out CNS metastases Evidence of tumor invading major blood vessels on imaging. The investigator or the local radiologist must exclude evidence of tumor that is fully contiguous with, surrounding, or extending into the lumen of a major blood vessel (e.g. pulmonary artery or superior vena cava). Prior treatment with an investigational or marketed agent that acts either by EGFR inhibition or anti-angiogenesis mechanism. EGFR inhibitors include (but are not limited to) erlotinib, gefitinib, cetuximab, CI-1033 or monoclonal antibody therapy. Angiogenesis inhibitors include (but are not limited to) bevacizumab, thalidomide, CP-547632, sunitinib, and sorafinib. Prior chemotherapy or treatment with another systemic anti-cancer agent NOTE: prior surgery and irradiation is permitted Radiotherapy within the last 4 weeks prior to first dose of study treatment. Palliative radiotherapy for bone lesions outside the thoracic region within 2 weeks prior to the first dose of study treatment. Surgery (including open biopsy), significant traumatic injury or radiotherapy within the last 4 weeks prior to first dose of study treatment or anticipation of the need for major surgery during study treatment Any known significant ophthalmologic abnormalities of the surface of the eye (The use of contact lenses is not recommended). Lactating women Fertile men or woman of childbearing potential not using effective methods to prevent pregnancy (e.g. oral contraceptives, intrauterine device or barrier method of contraception in conjunction with spermicidal jelly or surgically sterile) Malignancies other than NSCLC within 5 years prior to randomization, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer. Known hypersensitivity to any of the study drugs or their excipients Any disease (including psychotic disorders, drug abuse, active infection, uncontrolled hypertension, clinically significant cardiovascular disease for example CVA (< 6 months before randomization), myocardial infarction (< 6 months before randomization), unstable angina, NYHA > grade 2 CHF, arrhythmia requiring medication, hepatic, renal or metabolic disease), metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contra-indicates the use of an investigational drug or puts the patient at high risk for treatment-related complications History of thrombotic or hemorrhagic disorders Current or recent (within 10 days prior to study treatment start) use of full-dose oral or parenteral anticoagulants or thrombolytic agent for therapeutic (as opposed to prophylactic) purposes, including coumadin or warfarin Current or recent (within 10 days of first dose of study treatment) use of acetylic salicylic acid (> 325 mg/day) or treatment with dipyramidole, ticlopidine, clopidogrel and cilostazol. Treatment with any other investigational agent, or p

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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A Phase II study of Tarceva® in Combination with Avastin® versus chemotherapy plus Avastin® in 1st line advanced NSCLC patients - TASK

F. Hoffmann-La Roche

Updated 3/19/2012