Phase II Study of Roniciclib in Combination with Cisplatin/Etoposide or Carboplatin/Etoposide as First-Line Therapy in Patients with Extensive-Disease.

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Presentation transcript:

Phase II Study of Roniciclib in Combination with Cisplatin/Etoposide or Carboplatin/Etoposide as First-Line Therapy in Patients with Extensive-Disease Small Cell Lung Cancer Martin Reck, MD, PhD, Leora Horn, MD, MSc, Silvia Novello, MD, PhD, Fabrice Barlesi, MD, PhD, István Albert, MD, Erzsébet Juhász, MD, Dariusz Kowalski, MD, Gilles Robinet, MD, Jacques Cadranel, MD, PhD, Paolo Bidoli, MD, John Chung, PhD, Arno Fritsch, PhD, Uta Drews, PhD, Andrea Wagner, MD, Ramaswamy Govindan, MD Journal of Thoracic Oncology Volume 14, Issue 4, Pages 701-711 (April 2019) DOI: 10.1016/j.jtho.2019.01.010 Copyright © 2019 Terms and Conditions

Figure 1 Patient disposition. aOne patient in each treatment group did not receive treatment because of major protocol deviations (classed as treatment deviations), and each patient was excluded from the safety analysis. bEfficacy analyses were performed in the full analysis set, including all patients assigned to treatment (N = 142). cSafety analyses were performed in the safety analysis set, including all patients who received at least one dose of study treatment (n = 140). dOther includes protocol violation, loss to follow-up, study terminated by sponsor, physician’s decision, adverse event (AE) associated with clinical disease progression, switching to the other therapy, protocol-driven decision, deterioration of general condition, and intolerance. R, roniciclib; P, placebo; chemo, chemotherapy. AE, adverse event. Journal of Thoracic Oncology 2019 14, 701-711DOI: (10.1016/j.jtho.2019.01.010) Copyright © 2019 Terms and Conditions

Figure 2 Kaplan-Meier curves of progression-free survival (PFS) (full analysis set). chemo, chemotherapy; CI, confidence interval; P, placebo; R, roniciclib. Journal of Thoracic Oncology 2019 14, 701-711DOI: (10.1016/j.jtho.2019.01.010) Copyright © 2019 Terms and Conditions

Figure 3 Kaplan-Meier curves of overall survival (OS) (A), time to progression (TTP) (B), and duration of response (DoR) (C) (full analysis set). chemo, chemotherapy; CI, confidence interval; P, placebo; R, roniciclib. Journal of Thoracic Oncology 2019 14, 701-711DOI: (10.1016/j.jtho.2019.01.010) Copyright © 2019 Terms and Conditions