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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)

A Phase II Study of Atezolizumab with Bevacizumab for Patients with PD-L1 High Expression Non-Small Cell Non-Squamous Cell Lung Cancer (WJOG10718L Investigator-Initiated Clinical Trial)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080223980
Enrollment
38
Registered
2018-07-18
Start date
2018-08-10
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

non-small-cell lung cancer

Interventions

investigational material(s) Generic name etc : atezolizumab INN of investigational material : atezolizumab Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investig

Sponsors

Takashi Seto (Coordinating Investigator)
Lead Sponsor

Eligibility

Sex/Gender
All

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

MeasureTime frame
efficacy Overall response rate (ORR) by central assessment Tumor shrinkage will be assessed according to RECIST version 1.1.

Secondary

MeasureTime 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

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026