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Atezolizumab Monotherapy and Consequent Therapy With Atezolizumab Plus Bevacizumab for NSCLC

NCT03616691 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2018-08-06

No results posted yet for this study

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.

Conditions

  • Non Small Cell Lung Cancer

Interventions

DRUG

Atezolizumab

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)

DRUG

Bevacizumab

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.

Sponsors & Collaborators

  • Samsung Medical Center

    lead OTHER

Principal Investigators

  • Myung-Ju Ahn, PhD · Samsung Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-01
Primary Completion
2020-06-30
Completion
2020-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03616691 on ClinicalTrials.gov