Reck, 2016 trial summary

A randomised clinical trial investigating the effect of ipilimumab + chemotherapy versus placebo + chemotherapy in patients with newly diagnosed extensive-stage disease SCLC

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NCT01450761    J Clin Oncol 2016 Jul 25;:  



Studied treatment ipilimumab 10 mg/kg plus etoposide and platinum (cisplatin or carboplatin)
ipilimumab 10 mg/kg every 3 weeks for a total of four doses each in a phased induction schedule (chemotherapy in cycles one to four; ipilimumab beginning in cycle three up to cycle six), followed by ipilimumab maintenance every 12 weeks
Control treatment placebo plus etoposide and platinum (cisplatin or carboplatin)



Patients patients with newly diagnosed extensive-stage disease SCLC
Group sizes478 / 476



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



EndpointX1N1X0N0TE95% CI PFS - 478 - 476 no data OS - 478 - 476 no data grade 3 or 4 treatment-related adverse events - 478 - 476 no data treatment-related deaths - 478 - 476 no data any-grade serious TRAEs - 478 - 476 no data TRAEs leading to treatment discontinuation - 478 - 476 no data0,22,01,0

Reck M, Luft A, Szczesna A, Havel L, Kim SW, Akerley W, Pietanza MC, Wu YL, Zielinski C, Thomas M, Felip E, Gold K, Horn L, Aerts J, Nakagawa K, Lorigan P, Pieters A, Kong Sanchez T, Fairchild J, Spigel D Phase III Randomized Trial of Ipilimumab Plus Etoposide and Platinum Versus Placebo Plus Etoposide and Platinum in Extensive-Stage Small-Cell Lung Cancer. J Clin Oncol 2016 Jul 25;:     [PMID: 27458307]   link to pdf   add to Mendeley  

ClinicalTrial.gov record NCT01450761



Registering number NCT01450761 (see trial on clinicaltrials.gov)
Code Name