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
Overview
- Phase
- Phase 2
- Intervention
- Atezolizumab
- Conditions
- Non Small Cell Lung Cancer
- Sponsor
- Samsung Medical Center
- Enrollment
- 46
- Primary Endpoint
- The primary objective for this study is to evaluate efficacy of atezolizumab with bevacizumab after radiologically progress of atezolizumab monotherapy
- Last Updated
- 7 years ago
Overview
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.
Investigators
Myung-Ju Ahn
Professor
Samsung Medical Center
Eligibility Criteria
Inclusion Criteria
- •Patients must meet all of the following criteria to be eligible for study entry:
- •Signed Informed Consent Form
- •Ability to comply with protocol
- •20 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.
Exclusion Criteria
- •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
Arms & Interventions
Atezolizumab
The dose level of atezolizumab proposed to be tested in this study is 1200 mg administered by IV infusion every 3 weeks (q3w)
Intervention: Atezolizumab
Atezolimab+Bevacizumab
Once 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.
Intervention: Atezolizumab
Atezolimab+Bevacizumab
Once 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.
Intervention: Bevacizumab
Outcomes
Primary Outcomes
The primary objective for this study is to evaluate efficacy of atezolizumab with bevacizumab after radiologically progress of atezolizumab monotherapy
Time Frame: about 36 months
measured by disease control rate (DCR) per investigator using RECIST v1.1
Secondary Outcomes
- Best overall response rate(about 36 months)
- Progression-free survival(about 36 months)
- Overall survival(about 36 months)
- Adverse events (AEs)(about 36 months)
- Duration of response(about 36 months)