Advanced non-squamous non-small cell lung cancer
Conditions
Interventions
Combination chemotherapy of carboplatin + paclitaxel + bevacizumab
Combination chemotherapy of cisplatin + pemetrexed + bevacizumab
Sponsors
National Cancer Center Hospital East
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Histologically or cytologically proven non-squamous NSCLC (Mixed type is classified into dominant histology but mixed small cell histology is not permitted.) (2) Clinical stage IIIB or stage IV or recurrent non-squamous NSCLC for which they had not received any prior systemic chemotherapy, not candidate for curative radiotherapy (If patients have received adjuvant chemotherapy, the patients who experience recurrence after 48 weeks and have not received 1st line therapy are permitted.) (3) EGFR (Exon 19 deletion or Exon 21 L858R) mutation status is not active and ALK fusion gene is negative or unknown (4) ECOG Performance Status (PS) 0-1 (5) Patients who have at least one or more measurable lesion by RECIST(Version1.1) (6) Aged 20-74 at the time of consent (7) Adequate organ function (8) Interval 1) Radiation therapy More than 2 weeks after the last radiation therapy for nonthoracic region or brainmetastasis 2) Operation More than 4 weeks after the last operation More than 2 weeks after the last pleurodesis or thoracic drainage More than 4 weeks after the last operation with brain metastasis (9) Estimated life expectancy at least 12 weeks (10) Written informed consent
Exclusion criteria
Exclusion criteria: (1) Having treatment history of pemetrexed or paclitaxel or bevacizumab (2) History of pulmonary hemorrhage/hemoptysis defined as bright red blood of at least 2.5mL within 3 months prior to registration (3) Radiotherapy to lung field or mediastinum (4) Evidence of tumor invading a perihilar blood vessel, heart and major blood vessel on imaging (5) Evidence of tumor invading segmental bronchus (6) Evidence of cavitation in intra-thoracic lesion (7) Severe infection (8) Fever (over 38 degrees) (9) Having serious complications (10) Uncontrolled ascites, pleural effusion or cardiac effushion (11) Active concomitant malignancies (12) History of multiple malignancies within 5 years (13) Severe drug allergy (14) Active gastrointenstinal ulcer (15) History of gastrointestinal perforation within 1 year prior to registration (16) History of diverticulitis or fistula (17) Active hepatic disease (18) Embolic complications or having past history of arterial thrombosis or severe venous thrombosis within 1 year (19) Uncontrollable hypertention (20) Current or recent (within 10 days prior to first dose of bevacizumab) use of aspirin (> 325mg/day), clopidogrel (> 75mg/day), or anticlotting drug or thrombolytic agent (21) Symptomatic brain metastasis (22) Pregnant women (23) Patients whose participation in the trial is judged to be inappropriate by the doctor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (central review) | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, response rate, disease control rate, duration of response, time to treatment failure, toxicity | — |
Countries
Japan
Contacts
Public ContactHibiki Udagawa
National Cancer Center Hospital East Division of Thoracic Oncology
Outcome results
None listed