The INCA trial: a multicenter, randomized, phase II, open-label clinical trial to evaluate the combination therapy with Ipilimumab plus Nivolumab versus Chemotherapy (Pemetrexate-Cisplatin) in patients with Advanced non-squamous NSCLC naive to treatment

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Christian Barro
Allexya A. M. Affonso
Ahmed Waquar
Natalia Aragao
Ali Bakheet
Karen Cajiao
Alexandre B. C. Souza
Luis A. Q. Díaz
Carolyn M. Fowler
Renata Herrera
Luis A. N. Huapaya
Kira Kornienko
Andressa M. V. Magalhães
Tiago d. O. Menezes
María-Alicia Mordojovich
Ricardo Nosé
Hua Pan
Karoline S. Persivale
Claudia Poveda
Clara Ramos
Maria A. Rodrigues
José M. V. Ruiz
Rafael Soares
Xu DangHan

Abstract

Non-small cell lung cancer is a highly prevalent malignancy, whose social and economic burden have raised substantially in the previous decades. Novel progresses in the biological field have allowed the development of treatments aiming at regulatory check-points of our immune system. These new developments are shedding a hope towards an improvement in the quality of life and prognosis of affected individuals. Importantly, phase II studies have brought first evidences that a combination of two immune check points regulators, Ipilimumab and Nivolumab, could improve the overall prognosis of this disease. We describe a study design for a multicenter, randomized, phase II, open-label clinical trial which aims to compare the superiority of the combination Ipilimumab and Nivolumab versus chemotherapy (Pemetrexate-Cisplatin) in patients with advanced non-squamous non-small cell lung cancer naive to treatment.

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How to Cite
Barro, C., Affonso, A. A. M., Waquar, A., Aragao, N., Bakheet, A., Cajiao, K., Souza, A. B. C., Díaz, L. A. Q., Fowler, C. M., Herrera, R., Huapaya, L. A. N., Kornienko, K., Magalhães, A. M. V., Menezes, T. d. O., Mordojovich, M.-A., Nosé, R., Pan, H., Persivale, K. S., Poveda, C., Ramos, C., Rodrigues, M. A., Ruiz, J. M. V., Soares, R., & DangHan, X. (2018). The INCA trial: a multicenter, randomized, phase II, open-label clinical trial to evaluate the combination therapy with Ipilimumab plus Nivolumab versus Chemotherapy (Pemetrexate-Cisplatin) in patients with Advanced non-squamous NSCLC naive to treatment. Principles and Practice of Clinical Research, 4(1), 6-13. Retrieved from https://journal.ppcr.org/index.php/ppcrjournal/article/view/62
Section
Study Design

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