Table 2.
Clinical trials of targeted therapies in squamous NSCLC.
| Agents | Trial | Phase | Outcome |
Reference |
|---|---|---|---|---|
| (95% CI) | ||||
| EGFR | ||||
| Erlotinib versus placebo | BR21 | III | OS HR 0.70 (0.58–0.85) | Shepherd et al. (28) |
| Gefitinib versus D | INTEREST | III | OS HR 1.020 (0.905–1.150) | Kim et al. (29) |
| Afatinib versus erlotinib | LUX-Lung 8 | III | PFS HR 0.81 (0.69–0.96) | Soria et al. (30) |
| OS HR 0.81 (0.69–0.95) | ||||
| C + T ± cetuximab | BMS 099 | III | PFS HR 0.902 (0.761–1.069) | Lynch et al. (31) |
| OS HR 0.890 (0.754–1.051) | ||||
| Cis + V ± cetuximab | FLEX | III | OS HR 0.871 (0.762–0.996) | Pirker et al. (32) |
| Chemo ± cetuximab | Pujol et al. | Individual patient data meta-analysis | PFS HR 0.90 (0.82–1.00) | Pujol et al. (33) |
| OS HR 0.88 (0.79–0.97) | ||||
| Cis + G ± necitumumab | SQUIRE | III | OS HR 0.84 (0.74–0.96) | Thatcher et al. (34) |
| P ± matuzumab (1 versus 3 week) | Schiller et al. | Randomized II | ORR 5 versus 11% (p = 0.332)a | Schiller et al. (35) |
| OS 1 week HR 0.67 (0.3–0.21) | ||||
| OS 3 week HR 1.66 (0.9–0.86) | ||||
| C + T ± panitumumab | Crawford et al. | Randomized II | TTP HR 0.9 (0.66–1.21) | Crawford et al. (36) |
| FGFR | ||||
| D ± nintedanib | LUME-lung 1 | III | PFS HR 0.79 (0.68–0.92) | Reck et al. (37) |
| OS HR 0.94 (0.83–1.05) | ||||
| Dovitinib | Lim et al. | Single arm II | ORR 11.5% (0.8–23.8) | Lim et al. (38) |
| AZD4547 | Paik et al. | Ib | 0 CR, 1 PR, 4 SD, 9 PDb | Paik et al. (39) |
| BGJ398 | Nogova et al. | I | 15.4% PR, 34.6% SD | Nogova et al. (40) |
| 23.1% PR, 26.9% unknown | ||||
| PI3KCA | ||||
| Everolimus | Soria et al. | Single arm II | ORR 4.7% | Soria et al. (41) |
| Everolimus + D | Ramalingam et al. | Single arm II | ORR 8% | Ramalingam et al. (42) |
| Erlotinib ± everolimus | Besse et al. | Randomized II | PFS 0.769 (0.506–1.167) | Besse et al. (43) |
| Buparlisib | BASALT-1 | Single arm II | 12 week PFS 23.3% (9.9–42.3) | Vansteenkiste et al. (44) |
| D ± PX-866 | Levy et al. | Randomized II | med PFS 2 versus 2.9 mo (p = 0.65) | Levy et al. (45) |
| med OS 7.9 versus 9.4 mo (p = 0.9) | ||||
| Rb1/CDK | ||||
| Palbociclib | Gopalan et al. | Single arm II | ORR 0%, SD 50% (8/16) | Gopalan et al. (46) |
| Med PFS 12.5 week | ||||
| Abemaciclib | Patnaik et al. | I | ORR 3%, DCR 49% | Patnaik et al. (47) |
| DDR2 | ||||
| Dasatinib | Johnson et al. | Single arm II | DCR 43%, ORR 3% | Johnson et al. (48) |
| Med PFS 1.36 mo | ||||
| Med OS 11.4 mo | ||||
| Dasatinib + erlotinib | Haura et al. | I/II | DCR 62%, ORR 7% | Haura et al. (49) |
| Med PFS 2.7 mo | ||||
| Med OS 5.6 mo | ||||
| MET | ||||
| PL + TAX ± onartuzumab | Hirsch et al. | Randomized II | PFS HR 0.95 (0.63–1.43) | Hirsch et al. (50) |
| OS HR 0.90 (0.55–1.47) | ||||
| Erlotinib ± tivantinib | Sequist et al. | Randomized II | PFS HR 0.81 (0.57–1.16) | Sequist et al. (51) |
| OS HR 0.87 (0.59–1.27) | ||||
| Erlotinib ± onartuzumab | METLung | III | PFS HR 0.99 (0.81–1.20) | Spigel et al. (52) |
| OS HR 1.27 (0.98–1.65) | ||||
| Erlotinib ± onartuzumab | Spigel et al. | Randomized II | PFS HR 1.09 (0.73–1.62) | Spigel et al. (53) |
| OS HR 0.80 (0.50–1.28) | ||||
C, carboplatin; Cis, cisplatin; CR, complete response; D, docetaxel; DCR, disease control rate; G, gemcitabine; HR, hazard ratio; Med, median; ORR, objective response rate; OS, overall survival; P, pemetrexed; PD, progressive disease; PFS, progression-free survival; PL, platinum; PR, partial response; SD, stable disease; T, taxane; TAX, paclitaxel; TTP, time to progression; V, vinorelbine.
aORR in pem versus all matuzumab containing arms.
bRepresents number of patients with measured response as detailed.