non-small-cell lung cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with a histologically confirmed diagnosis of non-squamous NSCLC 2. Patients with the high PD-L1 expression (TPS>=50%, Dako 22C3 antibody) in tumor tissue by immunohistochemistry using archived tumor tissue samples collected in the past or tissue samples taken by a biopsy at screening 3. Patients who are confirmed to be negative for EGFR mutation, ALK gene translocation and ROS1 gene translocation 4. Patients with stage III and stage IV NSCLC not treatable with radical radiotherapy or postoperative recurrent NSCLC 5. Patients with measurable disease as defined by the RECIST version 1.1 6. Absence of brain metastasis that is symptomatic or requires antiedematous agents such as steroid or anticonvulsants for controlling symptoms 7. Patients who were not previously treated with both chemotherapy and radiotherapy including treatment for other cancer types 8. ECOG PS 0 or 1
Exclusion criteria
Exclusion criteria: 1. Patients with active other cancers except for NSCLC 2. Patients with a past or current history of hemoptysis 3. Presence of a bleeding tendency 4. Patients with a past or current history of interstitial lung disease evident on CT scans, drug-induced lung disorder and pneumonitis requiring steroid treatment 5. Hypertension uncontrollable with standard drug therapy 6. Patients with a history of serious hypersensitivity or with hypersensitivity to the ingredients or additives of atezolizumab and bevacizumab 7. Pregnant women, lactating women, women who may be pregnant at present or patients not intending to practice contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Overall response rate (ORR) by central assessment Tumor shrinkage will be assessed according to RECIST version 1.1. | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy PFS and DOR will be assessed based on RECIST version 1.1 and CTCAE will be used for safety assessment and so on PFS and DOR will be assessed based on RECIST version 1.1 and CTCAE will be used for safety assessment and so on. | — |
Countries
Japan