Table 1.
Randomized NSCLC clinical trials evaluating vandetanib
|
Study # Pts # prior chemo |
Design | RR (%) | PFS* | OS (m) |
|---|---|---|---|---|
| Randomized Phase II Trials | ||||
| Kiura 200838 53/1–2 |
All arms 1. V 100 mg 2. V 200 mg 3. V 300 mg |
13 17.6 5.6 16.7 |
TTP 8.3 weeks 12.3 weeks 12.3 weeks |
– |
| Natale 200939 168/1–2 |
1. V 300 mg 2. Gefitinib 250 mg daily; crossover allowed |
8 1 |
8.1 weeks 11.3 weeks HR .69, P = 0.013; |
6.1 7.4 NS |
| Heymach 200740 127/1 |
1. Docetaxel + V 100
mg 2. Docetaxel + V 300 mg 3. Docetaxel |
26 18 12 |
18.7 weeks^ 17 weeks 12 weeks^ ^HR 0.64, P = 0.037 |
13.1 7.9 13.4 |
| Heymach 200841 181/chemonaive |
1. Carboplatin/Paclitaxel + V
300 mg 2. Carboplatin/Paclitaxel 3. V 300 mg |
32 25 |
24 weeks (1). 23 weeks (2) HR 0.76; P = 0.098 [V alone arm closed] |
10.2 12.6 NS |
| Phase III Trials | ||||
| Natale 200949 ZEST 1240/1–2 |
1. V 300 mg 2. Erlotinib |
12 12 |
11.3 weeks 8.9 weeks HR 0.98; P = 0.721 |
6.9 7.8 NS |
| De Boer 200950 ZEAL 534/1 |
1. Pemetrexed + V 100
mg 2. Pemetrexed |
19 8 |
17.6 weeks 11.9 weeks HR 0.86; P = 0.108 |
10.5 9.2 NS |
| Herbst 200951 ZODIAC 1391/1 |
1. Docetaxel + V 100
mg 2. Docetaxel |
17 10 |
4 months 3.2 months HR 0.79; P <0.001 |
10.6 10 NS |
Note:
*
PFS primary endpoint of all trials except Kiura et al study38 where RR was primary endpoint.
Abbreviations: RR, response rate; PFS, progression-free survival; OS, overall survival; m, months; TTP, time to progression; V, vandetanib (given once daily in all studies); NS, not statistically significant.