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

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NCT01285609    J Clin Oncol 2017;35:3449-3457  



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 treatmentpaclitaxel and carboplatin



Patients Patients with stage IV or recurrent chemotherapy-naïve squamous NSCLC
Group sizes388 / 361



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



EndpointX1N1X0N0TE95% CI PFS - 388 - 361 no data OS - 388 - 361 0,91[0,77; 1,07] grade 3 or 4 treatment-related adverse events - 388 - 361 no data treatment-related deaths - 388 - 361 no data any-grade serious TRAEs - 388 - 361 no data TRAEs leading to treatment discontinuation - 388 - 361 no data0,22,01,0

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  

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ClinicalTrial.gov record NCT01285609



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