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

Author:

Andrini Elisa1ORCID,Lamberti Giuseppe12ORCID,Mazzoni Francesca3,Riccardi Ferdinando4,Bonetti Andrea5,Follador Alessandro6,Artioli Fabrizio7,Genova Carlo89,Barbieri Fausto10,Frassoldati Antonio11,Brighenti Matteo12,Colantonio Ida13,Pasello Giulia1415,Ficorella Corrado16,Cinieri Saverio17,Tiseo Marcello18,Gelsomino Francesco2,Tognetto Michele2,Rihawi Karim2,Ardizzoni Andrea2

Affiliation:

1. Department of Experimental, Diagnostic & Specialty Medicine (DIMES), University of Bologna, Bologna 40138, Italy

2. Medical Oncology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna 40138, Italy

3. Medical Oncology Unit, University Hospital Careggi, Firenze 50134, Italy

4. Oncology Unit - AORN Cardarelli, Naples 80131, Italy

5. Department of Oncology, Mater Salutis Hospital, Legnago 37045, Italy

6. Department of Oncology, University Hospital Santa Maria Della Misericordia, Udine 33100, Italy

7. Oncology & Palliative Care Units, Civil Hospital Carpi, USL, Carpi 41012, Italy

8. Academic Oncology Unit, IRCCS Ospedale Policlinico San Martino, Genoa 16132, Italy

9. Department of Internal Medicine & Medical Specialties (DiMI), Università degli Studi di Genova, Genoa 16132, Italy

10. Division of Medical Oncology, Azienda Ospedaliero-Universitaria Policlinico, Modena 41125, Italy

11. Department of Oncology, Azienda Ospedaliero Universitaria di Ferrara-Arcispedale Sant'Anna, Ferrara 44124, Italy

12. Medical Oncology Department, ASST Cremona, Cremona 26100, Italy

13. Medical Oncology Unit, Hospital of Cuneo, Cuneo 12100, Italy

14. Department of Surgery, Oncology & Gastroenterology, University of Padova, Padova 35122, Italy

15. Medical Oncology 2, Istituto Oncologico Veneto IRCCS, Padova 35122, Italy

16. Department of Biotechnological & Applied Clinical Sciences, St Salvatore Hospital, University of L'Aquila, L'Aquila 67100, Italy

17. Department of Oncology, Medical Oncology & Breast Unit, Antonio Perrino Hospital, Brindisi 72100, Italy

18. Department of Medicine & Surgery, University of Parma & Medical Oncology Unit, Azienda Ospedaliero-Universitaria di Parma, Parma 43126, Italy

Abstract

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.

Publisher

Future Medicine Ltd

Subject

Cancer Research,Oncology,General Medicine

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