Advanced or recurrent non-squamous non-small cell lung cancer. MedDRA version: PT Level: 7.0 Classification code 10061873
Conditions
Sponsors
F. Hoffmann-La Roche Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Age 18 years or over •Able to comply with the protocol •Histologically or cytologically documented inoperable, locally advanced (stage IIIb with supraclavicular lymph node metastases or malignant pleural or pericardial effusion), metastatic (stage IV) or recurrent non-squamous NSCLC (NOTE: In cases where the diagnosis is based on cytology only, representative samples have to be sent to Roche for central review. Patients for whom no representative samples can be sent should not be entered into the trial. Results of the review do not have to be awaited for randomization and treatment of the patient. Sputum cytology alone is not acceptable). Mixed tumors should be categorized according to the predominant cell type. •ECOG performance status 0-1 •Life expectancy > 12 weeks •Adequate hematological function : ANC greater than or equal to 1.5 x 10^9/L; platelets greater than or equal to 100 x 10^9/L, Hb greater than or equal to 9 g/dL •INR less than or equal to 1.5 and PTT less than or equal to 1.5 x ULN within 7 days prior to starting study treatment •Adequate liver function: Serum bilirubin less than or equal to 1.5 x ULN; transaminases less than or equal to 2.5 x ULN (in case of liver metastases =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Prior chemotherapy or treatment with another systemic anti-cancer agent (for example monoclonal antibody, tyrosine kinase inhibitor) NOTE: prior surgery and irradiation is permitted •Mixed, non-small cell and small cell tumors or mixed adenosquamous carcinomas with a predominant squamous component •History of = grade 2 hemoptysis (bright red blood of at least ½ teaspoon) •Brain metastases or spinal cord compression (CT or MRI of the head is required within 4 weeks prior to randomization) •Evidence of tumor invading or abutting major blood vessels •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 •Palliative radiotherapy for bone lesions outside the thoracic region within 2 weeks prior to the first dose of study treatment •Pregnant or lactating women •Fertile men or woman of childbearing potential not using adequate contraception (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, localized prostate cancer treated surgically with curative intent, DCIS treated surgically with curative intent •Treatment with any other investigational agent, or participation in another clinical trial within 30 days prior to starting study treatment •Known hypersensitivity to any of the study drugs •Non healing wound, ulcer or bone fracture •History of thrombotic or hemorrhagic disorders •Uncontrolled hypertension •Clinically significant cardiovascular disease for example CVA (less than or equal to 6 months before randomization), myocardial infarction (less than or equal to 6 months before randomization), unstable angina, NYHA greater than or equal to grade 2 CHF, arrhythmia requiring medication •Current or recent (within 10 days of first dose of study treatment) use of aspirin (> 325 mg/day) or treatment with dipyramidole, ticlopidine, clopidogrel and cilostazol. •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 •Evidence of any other disease, metabolic dysfunction, physical examination finding or 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate superiority in progression-free survival, when bevacizumab is added to cisplatin and gemcitabine;Secondary Objective: •To compare overall survival •To compare time to treatment failure •To compare response rate and assess duration of response •To evaluate and compare the safety profile of patients treated with 2 different doses of bevacizumab + cisplatin/gemcitabine versus cisplatin/gemcitabine •To study coagulation parameters •To characterize the pharmacokinetics of the combination bevacizumab, cisplatin and gemcitabine •To evaluate the relationship between baseline VEGF and clinical outcome parameters •To assess quality of life •To analyze pharmacoeconomics in all treatment arms - To analyze the pharmacogenetics in all treatment arms (in accordance with BO17704RG protocol).;Primary end point(s): Progression free survival defined as the time between randomisation and the time of progression or death. Patients without an event will be censored at the last tumour assessment either during follow up or during study treatment. Patients with no post-baseline assessments will be censored at the time of randomisation. | — |
Countries
Czech Republic, Germany, Hungary, Italy, Spain, United Kingdom
Outcome results
None listed