Non-small-cell Lung Cancer Patients Clinical Trial
Official title:
Phase II Randomized Trial Comparing Atezolizumab Versus Atezolizumab Plus Bevacizumab as First-line Treatment in PD-L1+ Advanced Metastatic Non-small-cell Lung Cancer Patients
phase II controlled randomized study comparing atezolizumab as single agent to the combination of atezolizumab and bevacizumab in patients with chemonaive metastatic NSCLC with PD-L1 expression. All NSCLC patients with tumor tissue available for biomarker assessment and candidate for first-line therapy are considered eligible for the study. After evaluation of all inclusion and exclusion criteria and after informed consent signature all eligible patients will be randomized to atezolizumab (Arm A) or to the combination of atezolizumab and bevacizumab (Arm B). Disease assessment will be performed every 6 weeks.
This is a phase II controlled randomized study comparing atezolizumab as single agent to the
combination of atezolizumab and bevacizumab in patients with chemonaive metastatic NSCLC with
PD-L1 expression.
A total of maximum of 206 patients will be enrolled in the study. Patients will be treated
with atezolizumab (1200 mg) every 3 weeks (6-week cycles) or the combination of atezolizumab
(1200 mg) every 3 weeks (6-week cycles) plus bevacizumab (15 mg/kg) every 3 weeks until
disease progression, unacceptable toxicity or patient refusal. Disease evaluation, along with
various assessments, will be made every 3 weeks and every 6 weeks and follow-up every 3
months. Toxicities will be evaluated throughout the study period. A follow-up of 12 months is
planned for each patient from the end of treatment .The study will be performed in
approximately 20 centers across Italy.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05568212 -
Randomized Trial Comparing Standard of Care Versus Immune- Based Combination in Relapsed Stage III Non-small-cell Lung Cancer (NSCLC) Pretreated With Chemoradiotherapy and Durvalumab
|
Phase 2 |