Non-small cell lung cancer
Conditions
Interventions
Bevacizumab after induction therapy of Carboplatin, Pemetrexed, and Bevacizumab
Bevacizumab with Pemetrexed after induction therapy of Carboplatin, Pemetrexed, and Bevacizumab
Sponsors
West Japan Oncology Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Induction therapy 1)Have non-squamous NSCLC and have not received any prior systemic chemotherapy including neoadjuvant /adjuvant therapy with Stage IIIB, not candidate for curative radiotherapy, Stage IV or recurrence disease after surgery a) Mixed type is classified into dominant histology but mixed small cell histology is not permitted b) Regarding the patient who have or have had pleural effusion; *A patient who requires treatment such as drainage of the pleural space is NOT eligible *A patient who remains without pleural effusion for more than two weeks after drainage is eligible *A patient with history of treatment with anticancer drugs (excluding BRM such as picibanil) for pleurodesis is NOT eligible 2)EGFR mutation status is not active (other than Exon 19 deletion or Exon 21 point mutation) or is not known 3)Have measurable lesion meeting Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, but radiation-irradiated lesion is not this case. 4)Must be 20 or more years old at the time of consent. 5)Have Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0~1 6)Have adequate organ function within one week before study entry 7)Have an estimated life expectancy of at least 90days 8)Have signed an informed consent document Maintenance therapy 1)Meet eligibility criteria between day15 and day43 (day 1 is the date when patients receive last dose of induction therapy) 2)No evidence of Progressive disease on chest CT after the 4th cycle of induction chemotherapy. Brain metastasis should be evaluated with the same modality as used in the base line assessment (MRI or CT) 3)Have ECOG PS 0~1 at the time of randomization 4)Have adequate organ function within 1 weeks before randomization
Exclusion criteria
Exclusion criteria: Induction therapy 1)Have CNS metastasis. (A case with locally treated asymptomatic brain metastasis can be registered.) 2)Have received radiation therapy to lesions of lung 3)Currently have or have a history of a cardiac effusion which requires treatment 4)Have another active malignancy 5)Currently have or have a history of hemoptysis, or hemosputum as defined below; a) continue hemosputum for more than one week b) have had or require continuous oral administration of hemostat c) have had or require injectable administration of hemostat 6)Have possibly complication related to bleeding episode a) Have a bleeding diathesis b) Have a evidence of involvement in major thoracic blood vassel c) Have a evidence of cavitation in intra-thoracic lesion d) Have a evidence of thrombosis 7)Have anti-thrombosis drugs within 10 days before enrollment or need them during the study 8)Currently have or have a history of the below disease; a) Currently have brain vascular disease with symptom, or have a history of it within one year before enrollment b) Have ever had a history of gastrointestinal perforation or diverticulitis or fistula c) Have symptomatic heart failure, unstable angina or arrhythmia which requires treatment, or have a history of cardiac infarction within one year before enrollment d) Have any evidence of interstitial lung disease, drug-induced interstitial disease, radiation pneumonitis or pulmonary fibrosis on chest X-ray or with clinically active symptom, or have medical history of it e) Currently have superior vena cava syndrome f) Currently have a cord compression g) Have a serious, nonhealing wound or unhealed bone fracture. h) Have an uncontrollable ulcer i) Have uncontrollable hypertension j) Have a serious concomitant active infection, which needs antibiotics, antimycotic drugs or virucide 9)have a known sensitivity to any component of platinum drugs or monoclonal antibody drugs 10)Not have time interval described after prior therapies at the time of study entry ...etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival from the date of randomization for maintenance therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival from the date of randomization for maintenance therapy, Overall Survival from the date of enrollment, Progression free survival from the date of enrollment, Adverse event | — |
Countries
Japan
Contacts
Public ContactShinichiro Nakamura
West Japan Oncology Group WJOG datacenter
Outcome results
None listed