A Phase II Study of Atezolizumab with Bevacizumab for Patients with Non-Small Cell Non-Squamous Cell Lung Cancer (At Be Study) (Investigator-Initiated Clinical Trial)
- Conditions
- non-small-cell lung cancer
- Registration Number
- JPRN-jRCT2080223980
- Lead Sponsor
- Takashi Seto (Coordinating Investigator)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 38
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>Overall response rate (ORR) by central assessment<br>Tumor shrinkage will be assessed according to RECIST version 1.1.
- Secondary Outcome Measures
Name Time Method safety<br>efficacy<br>PFS and DOR will be assessed based on RECIST version 1.1 and CTCAE will be used for safety assessment and so on<br>PFS and DOR will be assessed based on RECIST version 1.1 and CTCAE will be used for safety assessment and so on.