Table 1. List of Trials Characteristics.
| Source | Design | Entry Criteria | Line | Dominant Ethnicity, No. (%) |
Age (years) |
EGFR Mutation testing |
Treatments and dosing schedule | Arm A | Arm B | Median follow-up (mon) |
|---|---|---|---|---|---|---|---|---|---|---|
| WT/Total | WT/Total | |||||||||
| PD-1/PD-L1 vs CT | ||||||||||
| CheckMate 057, 2015 |
Open label, International, multicenter, phase 3 |
Patients with advanced nonsquamous NSCLC that had progressed during or after platinum-based CT PD-L1 positive |
Second or third |
White (91) |
62 (21–85) |
NR | Nivolumab (3 mg/kg every two weeks) vs docetaxel (75 mg/m2 every three weeks) |
168/292 | 172/290 | NR |
| KEYNOTE-010, 2015 |
Open label, International, multicenter, phase 2/3 |
Patients with advanced NSCLC that had progressed after platinum-based CT or TKI | Second | non-Asian (82) |
62 (56–69) |
Direct Sequencing/ ARMS |
Pembrolizumab (2 mg/kg or 10 mg/kg every three weeks) vs docetaxel (75 mg/m2 every three weeks) | 581/ (344/346) | 294/343 | 13.1 (IQR 8.6–17.7). |
| POPLAR, 2016, |
Open label, International, multicenter, phase 2 |
Patients with advanced NSCLC that had progressed after platinum-based CT or TKI | Second or third | White (100) |
62 (36–84) |
NR | Atezolizumab (1200 mg fixed dose every 3 weeks) vs docetaxel (75 mg/m2 every three weeks) | 147/287 | 14.8 vs 15.7* (0.1–19.6) |
|
| OAK, 2016 |
Open label, International, multicenter, phase 3 |
Patients with advanced NSCLC that had received platinum-based CT | Second or third |
White (70) |
64 (33–85) |
Direct Sequencing/ ARMS |
Atezolizumab (1200 mg fixed dose every 3 weeks) vs docetaxel (75 mg/m2 every three weeks) | 318/613 | 310/612 | 21.0 (NR) |
| TKI vs CT | ||||||||||
| INTEREST 2008 and 2010 |
Open label, International, multicenter, phase 3 |
TKI-naïve patients with advanced NSCLC that had progressed or recurred after platinum-based CT | Second or third |
White (74.4) |
61 (20–84) |
Direct sequencing |
Gefitinib (250 mg per day orally) vs docetaxel (75 mg/m2 every three weeks) |
123/733 | 106/733 | 7.6 (NR) |
| TITAN, 2012 |
Open label, International, multicenter, phase 3 |
TKI and pemetrexed-naïve patients with advanced NSCLC that had progression during or after platinum-based CT | Second | White (84.5) |
59 (22–80) |
Direct sequencing |
Erlotinib (150 mg per day orally) vs docetaxel (75 mg/m2 every three weeks) or pemetrexed (500 mg/m2 every three weeks) |
74/221 | 75/203 | 27.9 vs 24.8* (0.0–50.3) |
| TAILOR, 2013 |
Open label, multicenter, phase 3 |
TKI And taxanes-naïve patients with advanced NSCLC that had recurred or progressed after CT | Second | White (99.1) |
67 (35–83) |
Direct sequencing + fragment analysis |
Erlotinib (150 mg per day orally) vs docetaxel (75 mg/m2 every three weeks) |
110/110 | 109/112 | 33.0 (NR) |
| CT/06.05, 2013 |
Open label, multicenter, phase 3 |
TKI and pemetrexed-naïve patients with advanced NSCLC that had progressed during after CT | Second or third |
White (NR) |
66 (37–86) |
Direct sequencing |
Erlotinib (150 mg per day orally) vs pemetrexed (500 mg/m2 every three weeks) |
57/178 | 55/179 | 29.0 vs 27.3* (NR) |
|
NCT01565538, 2014 |
Open label, phase 2 |
TKI and pemetrexed-naïve patients with advanced NSCLC that had progressed during or after CT | Second | Asian (NR) |
55 (30–75) |
ARMS + FISH | Erlotinib (150 mg per day orally) vs pemetrexed (500 mg/m2 every three weeks) |
62/62 | 61/61 | 14·7 (0.5–41.9) |
| PROSE, 2014 |
Open label, multicenter, phase 3 |
TKI-naive patients with advanced NSCLC that that had recurred or progressed during or after CT | Second | White (NR) |
66 (33–85) |
MS | Erlotinib (150 mg per day orally) vs docetaxel (60 mg/m2 every three weeks) or pemetrexed (500 mg/m2 every three weeks) |
82/143 | 81/142 | 32·4 (IQR 22.3–44.5) |
| DELTA, 2014 |
Open label, multicenter, phase 3 |
TKI and docetaxel-naïve patients with advanced NSCLC that had progressed during or after platinum-based CT | Second or third |
Asian (NR) |
67 (31–85) |
Highly sensitive PCR-based method |
Erlotinib (150 mg per day orally) vs docetaxel (60 mg/m2 every three weeks) |
90/151 | 109/150 | 8.9 (NR) |
| CTONG 0806, 2014 |
Open label, multicenter, phase 2 |
TKI and pemetrexed-naïve patients with advanced NSCLC that had progressed after platinum-based CT | Second | Asian (NR) |
57 (24–78) |
Direct sequencing |
Gefitinib (250 mg per day orally) vs pemetrexed (500 mg/m2 every three weeks) |
76/76 | 81/81 | 10.6 (NR) |
Abbreviations: ARMS, amplification-refractory mutation system; CT, chemotherapy; EGFR, epidermal growth factor receptor; FISH, fluorescence in situ hybridization; IQR, interquartile range; MS, mass spectrometry; NR, not reported; NSCLC; non-small-cell lung cancer; PD-1, programmed death-1; PCR, polymerase chain reaction; PD-L1, programmed death-ligand 1; TKI, tyrosine kinase inhibitor; WT, wild type.
*arm A vs arm B.