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J Clin Oncol. 2017 Oct 20;35(30):3449-3457. doi: 10.1200/JCO.2016.71.7629. Epub 2017 Aug 30.

Phase III Trial of Ipilimumab Combined With Paclitaxel and Carboplatin in Advanced Squamous Non-Small-Cell Lung Cancer.

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Ramaswamy Govindan, Washington University School of Medicine, St Louis, MO; Aleksandra Szczesna, Mazowieckie Centrum Leczenia Chorób Płuc i Gruźlicy, Otwock; Jacek Jassem, Medical University of Gdansk, Gdansk, Poland; Myung-Ju Ahn, Samsung Medical Center, Sungkyunkwan University, Seoul; Ki Hyeong Lee, Chungbuk National University Hospital, Cheongju-si, Republic of Korea; Claus-Peter Schneider, Zentralklinik Bad Berka, Bad Berka; Joachim Von Pawel, Asklepius Fachkliniken, Gauting; Martin Reck, LungenClinic Grosshansdorf, Airway Research Center North, German Center for Lung Research, Grosshansdorf, Germany; Pablo Fernando Gonzalez Mella, Centro de Investigaciones Clinicas, Universidad de Valparaíso and Fundación Arturo López Pérez, Santiago, Chile; Fabrice Barlesi, Aix Marseille University, Assistance Publique-Hôpitaux de Marseille, Marseille, France; Baohui Han, Shanghai Chest Hospital Affiliated to Shanghai JiaoTong University, Shanghai; Li Zhang, Sun Yat-Sen University Cancer Center, Guangzhou, People's Republic of China; Doina Elena Ganea, Spitalul Judetean De Urgenta Suceava, Sfântul loan cel Nou, Suceava, Romania; Vladimir Vladimirov, State Healthcare Institute, Pyatigorsk Oncology Dispensary, Pyatigorsk; Natalia Fadeeva, Chelyabinsk Regional Oncology Dispensary, Chelyabinsk, Russian Federation; Takayasu Kurata, Kansai Medical University Hirakata Hospital, Osaka; Tomohide Tamura, St Luke's International Hospital, Tokyo, Japan; Pieter E. Postmus, University of Liverpool, Liverpool, United Kingdom; Kenneth O'Byrne, Princess Alexandra Hospital and Queensland University of Technology, Brisbane, Queensland, Australia; and Justin Kopit, Mingshun Li, and Marina Tschaika, Bristol-Myers Squibb, Princeton, NJ.


Purpose Patients with squamous non-small-cell lung cancer (NSCLC) have poor prognosis and limited treatment options. This randomized, double-blind, phase III study investigated the efficacy and safety of first-line ipilimumab or placebo plus paclitaxel and carboplatin in advanced squamous NSCLC. Patients and Methods Patients with stage IV or recurrent chemotherapy-naïve squamous NSCLC were randomly assigned (1:1) to receive paclitaxel and carboplatin plus blinded ipilimumab 10 mg/kg or placebo every 3 weeks on a phased induction schedule comprising six chemotherapy cycles, with ipilimumab or placebo from cycles 3 to 6 and then, after induction treatment, ipilimumab or placebo maintenance every 12 weeks for patients with stable disease or better. The primary end point was overall survival (OS) in patients receiving at least one dose of blinded study therapy. Results Of 956 randomly assigned patients, 749 received at least one dose of blinded study therapy (chemotherapy plus ipilimumab, n = 388; chemotherapy plus placebo, n = 361). Median OS was 13.4 months for chemotherapy plus ipilimumab and 12.4 months for chemotherapy plus placebo (hazard ratio, 0.91; 95% CI, 0.77 to 1.07; P = .25). Median progression-free survival was 5.6 months for both groups (hazard ratio, 0.87; 95% CI, 0.75 to 1.01). Rates of grade 3 or 4 treatment-related adverse events (TRAEs), any-grade serious TRAEs, and TRAEs leading to discontinuation were numerically higher with chemotherapy plus ipilimumab (51%, 33%, and 28%, respectively) than with chemotherapy plus placebo (35%, 10%, and 7%, respectively). Seven treatment-related deaths occurred with chemotherapy plus ipilimumab, and one occurred with chemotherapy plus placebo. Conclusion The addition of ipilimumab to first-line chemotherapy did not prolong OS compared with chemotherapy alone in patients with advanced squamous NSCLC. The safety profile of chemotherapy plus ipilimumab was consistent with that observed in previous lung and melanoma studies. Ongoing studies are evaluating ipilimumab in combination with nivolumab in this population.

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