A phase II, open-label, single-arm trial of carboplatin plus etoposide with bevacizumab and atezolizumab in patients with extended-stage small-cell lung cancer (CeLEBrATE study): background, design and rationale.
Elisa AndriniGiuseppe LambertiFrancesca MazzoniFerdinando RiccardiAndrea BonettiAlessandro FolladorFabrizio ArtioliCarlo GenovaFausto BarbieriAntonio FrassoldatiMatteo BrighentiIda ColantonioGiulia PaselloCorrado FicorellaSaverio CinieriMarcello TiseoFrancesco GelsominoMichele TognettoKarim RihawiAndrea ArdizzoniPublished in: Future oncology (London, England) (2022)
Based on improved survival from the addition of PD-L1 inhibitors in phase III trials, the combination of immunotherapy and platinum-doublet chemotherapy has become the new standard treatment for extended-stage small-cell lung cancer (ES-SCLC). Furthermore, the antiangiogenetic agent bevacizumab showed a longer progression-free survival by targeting VEGF that has pleiotropic effects, including immunosuppressive ones. We, therefore, hypothesized that targeting angiogenesis would improve the efficacy of chemoimmunotherapy. The CeLEBrATE trial is an open-label, multicenter, phase II study designed to assess the efficacy and safety of the combination of carboplatin and etoposide plus bevacizumab and atezolizumab in treatment-naive patients with ES-SCLC. The primary end point is overall survival rate at 1 year, while secondary end points include overall response rate, progression-free survival and toxicity.
Keyphrases
- phase iii
- open label
- free survival
- phase ii
- phase ii study
- clinical trial
- small cell lung cancer
- study protocol
- double blind
- placebo controlled
- endothelial cells
- locally advanced
- vascular endothelial growth factor
- metastatic colorectal cancer
- randomized controlled trial
- hiv infected
- antiretroviral therapy
- replacement therapy