Locally advanced (Stage IIIb with supraclavicular lymph node metastases or malignant pleural or pericardial effusion) or metastatic (Stage IV) non-squamous non small cell lung cancer (NSCLC). MedDRA version: 9.1 Level: PT Classification code 10061873
Conditions
Interventions
Trade Name: Bevacizumab
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Bevacizumab
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number:
Sponsors
ROCHE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: NSCLC patients aged ≥ 70 years without important comorbidities 1.Written informed consent (informed consent document to be approved by the institutions Independent Ethics Committee and consent obtained prior to any study-specific procedure) 2.Age ≥ 70 years 3.At least one bidimensionally measurable lesion meeting RECIST criteria 4.Histologically or cytologically documented inoperable, locally advanced (stage IIIb with supraclavicular lymph node metastases or malignant pleural or pericardial effusion) or metastatic (Stage IV) non-squamous NSCLC 5.Eastern Cooperative Oncology Group PS 0-1 6.Life expectancy ≥ 12 weeks 7.Adequate haematological function: - Absolute neutrophil count (ANC) ≥ 1.5 x 109/L AND - Platelet count ≥ 100 x 109/L AND - Haemoglobin ≥ 9 g/dL (may be transfused to maintain or exceed this level) 8.Adequate liver function: - Total bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Mixed, non-small cell and small cell tumors or mixed adenosquamous carcinomas with a predominant squamous component. 2.Prior chemotherapy or treatment with another systemic anti-cancer agent for lung cancer (including Monoclonal antibodies or Tyrosine kinase inhibitors). 3.History of grade ≥ 2 haemoptysis (bright red blood of at least half a teaspoon) in the 3 months prior to enrolment 4.Evidence of tumour invading major blood vessels on imaging. (e.g. pulmonary artery or superior vena cava). 5.Neoadjuvant/adjuvant chemotherapy within 6 months prior to enrolment 6.Radiotherapy within 28 days prior to enrolment 7.Surgery (including open biopsy), significant traumatic injury within 28 days prior to enrolment or anticipation of the need for major surgery during study treatment. 8.Minor surgery, including insertion of an indwelling catheter, within 24 hours prior to the first bevacizumab infusion 9.Current or recent (within 10 days of first dose of bevacizumab) use of aspirin (> 325 mg/day) 10.Current or recent (within 10 days of first dose of bevacizumab) use of full-dose oral or parenteral anticoagulants or thrombolytic agent for therapeutic purposes. Prophylactic use of anticoagulants is allowed 11.History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding 12.Uncontrolled hypertension (blood pressures: systolic >150 mmHg and/or diastolic >100 mmHg) 13.Clinically significant (i.e. active) cardiovascular disease for example CVA (≤ 6 months before enrolment), myocardial infarction (≤ 6 months before enrolment), unstable angina, congestive heart failure NYHA Class ≥ II, serious cardiac arrhythmia requiring medication during the study and might interfere with regularity of the study treatment, or not controlled by medication 14.Non-healing wound, active peptic ulcer or bone fracture or history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months of enrolment 15.Treatment with any other investigational agent, or participation in another clinical trial within 28 days prior to enrolment 16.Known hypersensitivity to bevacizumab or any of its excipients, and any of the chemotherapies 17.Patients diagnosed with a tracheo-oesophageal fistula. 18.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 19.History of thrombotic disorders within the last 6 months prior to enrolment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate bevacizumab + gemcitabine combination and bevacizumab + cisplatin + gemcitabine combination in elderly patients with non-squamous NSCLC by using 6-month Progression Free Rate (PFR) as primary endpoint.;Secondary Objective: 1.To describe Progression-Free Survival (PFS) in the two treatment schedules 2.To describe the 1-year survival rate after randomization in the two treatment schedules 3.To describe the Objective Response Rate (ORR) and the Duration of Response in the two treatment schedules 4.To describe the Best Overall response rate in the two treatment schedules 5.To describe the tolerability and safety of each of the trial schedules;Primary end point(s): The primary end-point of this study is 6-month progression free rate (PFR). | — |
Countries
Italy
Outcome results
None listed