Govindan, 2017 trial summary

A randomised clinical trial investigating the effect of ipilimumab + chemotherapy versus placebo + chemotherapy in Patients with stage IV or recurrent chemotherapy-naïve squamous NSCLC

Studied treatment	ipilimumab 10 mg/kg + paclitaxel and carboplatin ipilimumab 10 mg/kg every 3 weeks on a phased induction schedule comprising six chemotherapy cycles, with ipilimumab from cycles 3 to 6 and then, after induction treatment, ipilimumab maintenance every 12 weeks for patients with stable disease or better
Control treatment	placebo + paclitaxel and carboplatin
Concomittant treatment	paclitaxel and carboplatin

Patients	Patients with stage IV or recurrent chemotherapy-naïve squamous NSCLC
Group sizes	388 / 361

Blindness	double-blind	Inclusion period
Follow-up duration		Centers
Lost to FU		geographical localisation
Primary endpoint	OS	Design	Parallel groups

Govindan R, Szczesna A, Ahn MJ, Schneider CP, Gonzalez Mella PF, Barlesi F, Han B, Ganea DE, Von Pawel J, Vladimirov V, Fadeeva N, Lee KH, Kurata T, Zhang L, Tamura T, Postmus PE, Jassem J, O'Byrne K, Kopit J, Li M, Tschaika M, Reck M Phase III Trial of Ipilimumab Combined With Paclitaxel and Carboplatin in Advanced Squamous Non-Small-Cell Lung Cancer. J Clin Oncol 2017;35:3449-3457 [PMID: 28854067] link to pdf add to Mendeley

Links

ascopubs

ClinicalTrial.gov record NCT01285609

Registering number	NCT01285609 (see trial on clinicaltrials.gov)
Code Name	CA184-104