Table 2 Completed randomized phase II studies with targeted agents in advanced gastric cancer
Target | Agent | Trial | Selection biomarker/trial design | Progression-free survival benefit/months (experimental versus control) |
|---|---|---|---|---|
HER2 | Trastuzumab | WJOG7112G (T-ACT)/2nd-line [18] | HER2/paclitaxel with or without trastuzumab | Negative (HR 0.91)/3.68 versus 3.19 |
Angiogenesis | Sorafenib | STARGATE/1st-line [80] | None/chemotherapy with or without sorafenib | Negative (HR 0.92)/5.6 versus 5.3 |
Ziv-aflibercept | MEGA/1st-line [79] | None/mFOLFOX6 with ziv-aflibercept or placebo | Negative (HR 1.11)/9.7 versus 7.4 | |
Sunitinib | NCT01238055/2nd-line [83] | None/docetaxel with or without sunitinib | Negative (HR 0.77 [95% CI 0.52–1.16])/3.9 versus 2.6 (time to progression) | |
Regorafenib | INTEGRATE/3rd-line [81] | None/regorafenib versus placebo | Positive (HR 0.40)/2.6 versus 0.9 | |
Ramucirumab | RAINSTORM/1st-line [69] | HER2(−)/chemotherapy with ramucirumab or placebo in Asian patients | Negative (HR 1.07)/6.34 versus 6.74 | |
Ramucirumab | NCT01246960/1st-line [65] | None/mFOLFOX6 with ramucirumab or placebo | Negative (HR 0.98)/6.4Â versus 6.7 | |
Pazopanib | NCT01503372/1st-line [85] | HER2(−)/chemotherapy with or without pazopanib | Negative (HR 0.93)/5.1 versus 3.9 | |
FGFR | AZD4547 | SHINE/2nd-line [112] | FGFR/AZD4547 versus paclitaxel | Negative (HR 1.57)/1.8 versus 3.5 |
Claudin 18.2 | IMAB362 | FAST/1st-line [118] | Claudin 18.2 & HER2(−)/chemotherapy with or without IMAB362 | Positive (HR 0.44)/7.5 versus 5.3 |
Smoothened (Hedgehog signaling) | Vismodegib | NCT00982592/1st-line [129] | None/mFOLFOX6 with vismodegib or placebo | Negative/7.3 versus 8.0 |