Atezolizumab Monotherapy and Consequent Therapy With Atezolizumab Plus Bevacizumab for NSCLC
A Phase II Single-arm Trial of Atezolizumab Monotherapy and Consequent Therapy With Atezolizumab Plus Bevacizumab in Patients With Non-Small Cell Lung Cancer After Failure With Platinum-Containing Chemotherapy
1 other identifier
interventional
46
0 countries
N/A
Brief Summary
This is a single-arm phase II trial to evaluate the efficacy and safety of atezolizumab and bevacizumab combination therapy (stage 2) after radiologic progression of atezolizumab monotherapy (stage 1) in Korean patients with locally advanced or metastatic NSCLC who have progressed during or following a platinum-containing regimen. Initially, patients will be treated with Atezolizumab 1200mg every 3 weeks as a single agent (stage 1). After radiologic progression from atezolizumab monotherapy, patients will be consequently treated with atezolizumab (1200mg every 3 weeks) and combination with bevacizumab (15mg/kg every 3 weeks). Exploratory biomarkers will be observed in order to identify predictive biomarkers correlated to response and to evaluate the changes of local and systemic immune profile between baseline and at the time of progression.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Aug 2018
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 18, 2018
CompletedStudy Start
First participant enrolled
August 1, 2018
CompletedFirst Posted
Study publicly available on registry
August 6, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2020
CompletedAugust 6, 2018
August 1, 2018
1.9 years
July 18, 2018
August 3, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
The primary objective for this study is to evaluate efficacy of atezolizumab with bevacizumab after radiologically progress of atezolizumab monotherapy
measured by disease control rate (DCR) per investigator using RECIST v1.1
about 36 months
Secondary Outcomes (5)
Best overall response rate
about 36 months
Progression-free survival
about 36 months
Duration of response
about 36 months
Overall survival
about 36 months
Adverse events (AEs)
about 36 months
Study Arms (2)
Atezolizumab
EXPERIMENTALThe dose level of atezolizumab proposed to be tested in this study is 1200 mg administered by IV infusion every 3 weeks (q3w)
Atezolimab+Bevacizumab
EXPERIMENTALOnce radiologic progression confirmed from atezolizumab monotherapy (stage 1), 1200mg of atezolizumab would be administered with 15mg/kg of bevacizumab as combination therapy (stage 2). Both of drugs are administered via intravenous infusion every 3 weeks.
Interventions
Stage I: The dose level of atezolizumab proposed to be tested in this study is 1200 mg administered by IV infusion every 3 weeks (q3w)
Stage II: Once radiologic progression confirmed from atezolizumab monotherapy (stage 1), 1200mg of atezolizumab would be administered with 15mg/kg of bevacizumab as combination therapy every 3 weeks.
Eligibility Criteria
You may qualify if:
- Patients must meet all of the following criteria to be eligible for study entry:
- Signed Informed Consent Form
- Ability to comply with protocol
- years old or older
- Histologically confirmed stage IIIb, IV or recurrent non-squamous cell NSCLC
- Baseline and repeat biopsy at the time of progression is mandatory. Repeat biopsy at progression to atezolizumab with bevacizumab is optional.
- Disease progression during or following treatment with a prior platinum-containing regimen for locally advanced, unresectable/inoperable or metastatic NSCLC or disease recurrence within 6 months of treatment with a platinum-based adjuvant/neoadjuvant regimen or combined modality (e.g.,chemoradiation) regimen with curative intent.
- ECOG performance status of 0 to 1
- At least one measurable lesion by RECIST v1.1
- Patients with brain metastasis may be enrolled provided they are asymptomatic requiring no treatment, or are asymptomatic following therapy such as surgery, WBRT or SRT.
- Adequate hematologic and end organ function, defined by the following laboratory results obtained within 14 days prior to the first study treatment:
You may not qualify if:
- Patients who meet any of the following criteria will be excluded from study entry.
- Prior treatment with anti-PD1 or anti-PDL1 inhibitors
- Patients with a known hypersensitivity to atezolizumab and/or bevacizumab or any of the excipients.
- History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.
- Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells.
- Patients with a sensitizing EGFR mutation
- Patients with a previously detected ALK fusion oncogene
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment
- Active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease
- Evidence of interstitial lung disease or active, non-infectious pneumonitis
- Has received a live vaccine within 30 days prior to the first dose of trial treatment
- Has a known history of Human Immunodeficieny Virus (HIV)
- Has known active Hepatitis B (e.g. HBsAg reactive) or Hepatitis C (e.g. HCV RNA is detected)
- Surgery undertaken less than 4 weeks before the study
- Localized radiotherapy unless completed more than 2 weeks before the study
- +20 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Myung-Ju Ahn, PhD
Samsung Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 18, 2018
First Posted
August 6, 2018
Study Start
August 1, 2018
Primary Completion
June 30, 2020
Study Completion
June 30, 2020
Last Updated
August 6, 2018
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will not share