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We describe the long\u2010term safety and efficacy data from a previously reported phase Ib study of nivolumab and chemotherapy. Japanese patients with non\u2010small\u2010cell lung cancer were assigned to a treatment arm based on histology and treatment history. Nivolumab (10\u00a0mg\/kg, i.v.) and chemotherapy (4 arms) were given every 3\u00a0weeks: arm A, 4 cycles of cisplatin and gemcitabine (first\u2010line); arm B, 4 cycles of cisplatin and pemetrexed followed by pemetrexed maintenance therapy (first\u2010line); arm C, 4\u20106 cycles of carboplatin, paclitaxel, and bevacizumab followed by bevacizumab (first\u2010line); and arm D, docetaxel (second\u2010 or third\u2010line). Study treatments were continued every 3\u00a0weeks as maintenance therapy until disease progression. Minimum follow\u2010up period was 57.9\u00a0months. Median progression\u2010free survival (median [range, plus sign indicates censored data]) was 6.3 (0.7+\u201047.8), 11.8 (1.4\u201065.1+), 40.7 (5.3\u201060.8+), and 3.2 (1.9\u201010.9) months, and 5\u2010year progression\u2010free survival was observed in 0\/6, 1\/6, 1\/6, and 0\/6 patients in arms A, B, C, and D, respectively. Median overall survival was 13.2 (11.0\u201055.4), 28.5 (14.6\u201066.2+), not reached (24.2\u201067.4+), and 12.5 (9.8\u201016.9) months; the number of patients surviving 5\u00a0years were 0\/6, 1\/6, 4\/6, and 0\/6 in arms A, B, C, and D, respectively. No unexpected severe adverse events or treatment\u2010related deaths occurred. Nivolumab and platinum\u2010based chemotherapy combinations showed long\u2010term tolerability. A moderate proportion of patients in arm C showed 5\u2010year progression\u2010free and overall survival.<\/jats:p>","DOI":"10.1111\/cas.14410","type":"journal-article","created":{"date-parts":[[2020,4,11]],"date-time":"2020-04-11T07:53:26Z","timestamp":1586591606000},"page":"1933-1942","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":13,"title":["Five\u2010year safety and efficacy data from a phase Ib study of nivolumab and chemotherapy in advanced non\u2010small\u2010cell lung cancer"],"prefix":"10.1111","volume":"111","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7864-3928","authenticated-orcid":false,"given":"Shintaro","family":"Kanda","sequence":"first","affiliation":[{"name":"Department of Thoracic Oncology National Cancer Center Hospital Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6137-073X","authenticated-orcid":false,"given":"Yuichiro","family":"Ohe","sequence":"additional","affiliation":[{"name":"Department of Thoracic Oncology National Cancer Center Hospital Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yasushi","family":"Goto","sequence":"additional","affiliation":[{"name":"Department of Thoracic Oncology National Cancer Center Hospital Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9090-801X","authenticated-orcid":false,"given":"Hidehito","family":"Horinouchi","sequence":"additional","affiliation":[{"name":"Department of Thoracic Oncology National Cancer Center Hospital Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6981-0800","authenticated-orcid":false,"given":"Yutaka","family":"Fujiwara","sequence":"additional","affiliation":[{"name":"Department of Respiratory Medicine Mitsui Memorial Hospital Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hiroshi","family":"Nokihara","sequence":"additional","affiliation":[{"name":"Department of Respiratory Medicine and Rheumatology Graduate School of Biomedical Sciences Tokushima University Tokushima Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0787-2851","authenticated-orcid":false,"given":"Noboru","family":"Yamamoto","sequence":"additional","affiliation":[{"name":"Department of Thoracic Oncology National Cancer Center Hospital Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Takanori","family":"Yamamoto","sequence":"additional","affiliation":[{"name":"Oncology Clinical Development Planning 1 Ono Pharmaceutical Co. 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