Table 3: Phase III trials with improved overall survival in second-line treatment.

 

Trial

N

Treatment

ECOG PS

PFS

OS

TAX317 Shepherd et al.

JCO 2000 [24]

204

Docetaxel vs. BSC

0-2

10.6 vs. 6.7 weeks (TTP), p = 0.001

7.0 vs. 4.6 months,

p = 0.047

Hanna et al. JCO 2004 [25]

571

Pemetrexed vs. docetaxel

0-2

2.9 vs. 2.9 months

8.3 vs. 7.9 months

BR.21

Shepherd et al. NEJM 2005 [27]

731

Erlotinib vs. placebo

(2nd or 3rd line)

0-3

2.2 vs. 1.8 months,

p < 0.001

6.7 vs. 4.7 months,

p < 0.001

INTEREST

Kim et al. Lancet 2008 [29]

1466

Gefitinib vs. docetaxel

(2nd or 3rd line)

0-2

2.2 vs. 2.7 months,

p = 0.47

7.6 vs. 8.0 months, p = 0.50

(non-inferior)

LUME-Lung 1 Reck et al.

Lancet Oncol 2014 [36]

655

Docetaxel + nintedanib vs. docetaxel + placebo

0-1

3.4 vs. 2.7 months,

p = 0.0019

10.1 vs. 9.1 months,

p = 0.2720

(12.6 vs. 10.3 mosinpts with adenoCa, p = 0.036)

REVEL

Garon et al. Lancet 2014 [37]

1253

Docetaxel + ramucirumab vs. docetaxel + placebo

0-1

4.5 vs. 3.0 months,

p < 0.0001

10.5 vs. 9.1 months,

p = 0.023

CheckMate 017

Brahmer et al. NEJM 2015 [48]

272

Nivolumab vs. docetaxel (squamous cell carcinoma)

0-1

3.5 vs. 2.8 months,

p = 0.008

9.2 vs. 6.0 months,

p < 0.001

CheckMate 057

Borghaei et al. NEJM 2015 [49]

582

Nivolumab vs. docetaxel

(non-squamous NSCLC)

0-1

2.3 vs. 4.2 months,

p = NR

12.2 vs. 9.4 months,

 p = 0.002

KEYNOTE-010 Herbst et al. Lancet 2015 [50]

1034

Pembrolizumab 2 mg/kg vs. 10 mg/kg vs. docetaxel

0-1

3.9 vs. 4.0 vs. 4.0 months p = NS

10.4 vs. 12.7 vs. 8.5 months,

2 mg/kg vs. D: p = 0.0008,

10 mg/kg vs. D: p < 0.0001,

2 vs. 10:

p = NS

LUX-Lung 8 Soria et al. Lancet Oncol 2015 [33]

795

Afatinib vs. erlotinib

(squamous cell)

0-1

2.4 vs. 1.9 months,

p = 0.0427

7.9 vs. 6.8 months,

p = 0.0077