A randomized, multicenter phase III study of lobaplatin/etoposide versus cisplatin/etoposide as first-line therapy in patients with extensive-stage small-cell lung cancer and circulating tumor cells (CTCs) as an exploratory biomarker.

2014 ◽  
Vol 32 (15_suppl) ◽  
pp. 7595-7595 ◽  
Author(s):  
Ying Cheng ◽  
Yun Fan ◽  
Xiaoqing Liu ◽  
Yunpeng Liu ◽  
Jiwei Liu ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell ◽  
Phase Iii ◽  
Small Cell Lung ◽  
First Line ◽  
First Line Therapy ◽  
Multicenter Phase ◽  
Line Therapy ◽  
Phase Iii Study ◽  
Extensive Stage

scholarly journals Pembrolizumab or Placebo Plus Etoposide and Platinum as First-Line Therapy for Extensive-Stage Small-Cell Lung Cancer: Randomized, Double-Blind, Phase III KEYNOTE-604 Study

2020 ◽  
Vol 38 (21) ◽  
pp. 2369-2379 ◽  
Author(s):  
Charles M. Rudin ◽  
Mark M. Awad ◽  
Alejandro Navarro ◽  
Maya Gottfried ◽  
Solange Peters ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Small Cell ◽  
Phase Iii ◽  
Small Cell Lung ◽  
First Line ◽  
Double Blind ◽  
First Line Therapy ◽  
Line Therapy ◽  
Extensive Stage

PURPOSE Pembrolizumab monotherapy has shown antitumor activity in patients with small-cell lung cancer (SCLC). The randomized, double-blind, phase III KEYNOTE-604 study compared pembrolizumab plus etoposide and platinum (EP) with placebo plus EP for patients with previously untreated extensive-stage (ES) SCLC. METHODS Eligible patients were randomly assigned 1:1 to pembrolizumab 200 mg once every 3 weeks or saline placebo for up to 35 cycles plus 4 cycles of EP. Primary end points were progression-free survival (PFS; RECIST version 1.1, blinded central review) and overall survival (OS) in the intention-to-treat population. Objective response rate (ORR) and duration of response were secondary end points. Prespecified efficacy boundaries were one-sided P = .0048 for PFS and .0128 for OS. RESULTS Of the 453 participants, 228 were randomly assigned to pembrolizumab plus EP and 225 to placebo plus EP. Pembrolizumab plus EP significantly improved PFS (hazard ratio [HR], 0.75; 95% CI, 0.61 to 0.91; P = .0023). Twelve-month PFS estimates were 13.6% with pembrolizumab plus EP and 3.1% with placebo plus EP. Although pembrolizumab plus EP prolonged OS, the significance threshold was not met (HR, 0.80; 95% CI, 0.64 to 0.98; P = .0164). Twenty-four-month OS estimates were 22.5% and 11.2%, respectively. ORR was 70.6% in the pembrolizumab plus EP group and 61.8% in the placebo plus EP group; the estimated proportion of responders remaining in response at 12 months was 19.3% and 3.3%, respectively. In the pembrolizumab plus EP and placebo plus EP groups, respectively, any-cause adverse events were grade 3-4 in 76.7% and 74.9%, grade 5 in 6.3% and 5.4%, and led to discontinuation of any drug in 14.8% and 6.3%. CONCLUSION Pembrolizumab plus EP significantly improved PFS compared with placebo plus EP as first-line therapy for patients with ES-SCLC. No unexpected toxicities were seen with pembrolizumab plus EP. These data support the benefit of pembrolizumab in ES-SCLC.

scholarly journals A phase Ib dose-escalation study of everolimus combined with cisplatin and etoposide as first-line therapy in patients with extensive-stage small-cell lung cancer

2014 ◽  
Vol 25 (2) ◽  
pp. 505-511 ◽  
Author(s):  
B. Besse ◽  
R.S. Heist ◽  
V.A. Papadmitrakopoulou ◽  
D.R. Camidge ◽  
J.T. Beck ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Dose Escalation ◽  
Small Cell ◽  
Small Cell Lung ◽  
First Line ◽  
Dose Escalation Study ◽  
Phase Ib ◽  
First Line Therapy ◽  
Line Therapy ◽  
Extensive Stage

scholarly journals A German multicenter, randomized phase III trial comparing irinotecan–carboplatin with etoposide–carboplatin as first-line therapy for extensive-disease small-cell lung cancer

2011 ◽  
Vol 22 (8) ◽  
pp. 1798-1804 ◽  
Author(s):  
A. Schmittel ◽  
M. Sebastian ◽  
L. Fischer von Weikersthal ◽  
P. Martus ◽  
T.C. Gauler ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Small Cell ◽  
Phase Iii ◽  
Small Cell Lung ◽  
First Line ◽  
Extensive Disease ◽  
Phase Iii Trial ◽  
First Line Therapy ◽  
Line Therapy
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