Table 1.
Clinical Trial/Phase | Patients | Treatment | No. of pts | ORR (%) | Median PFS (months) | HR (95% CI); P | Median OS (months) | HR (95% CI); P |
---|---|---|---|---|---|---|---|---|
ECOG4599 | Previously untreated advanced, metastatic or recurrent NSCLC | CP+BeV CP and CP+BeV |
434 444 |
35 15 |
6.2 4.5 |
HR=0.66 (0.57–0.77) P<0.001 |
12.3 10.3 |
HR=0.79 (0.67–0.92) P=0.003 |
NCT00762034 (POINTBREAK) | Previously untreated IIIB or IV nonsq-uamous NSCLC | PemCBev PacCBev |
472 467 |
34 33 |
5 5.6 |
HR=0.83 (0.71–0.96) P=0.012 |
12.6 13.4 |
HR=1.0 (0.86–1.16) P=0.949 |
NCT00961415 (AVAPERL1) | inoperable, LA, metastatic or recurrent nonsquamous NSCLC | PemCisBev→PemBev PemCisBev→Bev |
128 125 |
-- | 7.4 3.7 |
HR=0.57 (0.44–0.75) P<0.0001 |
17.1 13.3 |
HR=0.87 (0.63–1.21) P=0.29 |
NCT01364012 (BEYOND) | Previously Naive-palliative chemotherapy recurrent or advanced nonsquamous NSCLC | PacC+Bev PacC+Placebo |
138 138 |
54 26 |
9.2 6.5 |
HR=0.40 (0.29–0.54) P<0.001 |
24.3 17.7 |
HR=0.68 (0.50–0.93) P=0.0154 |
NCT01168973 (REVEL) | stage IV NSCLC after platinum-based therapy | Doc+Ram Doc+Placebo |
628 625 |
23 14 |
4.5 3.0 |
HR=0.76 (0.68–0.86) P<0.0001 |
10.5 9.1 |
HR=0.86 (0.75–0.98) P<0.023 |
NCT00805194 (LUME-lung 1) | advanced NSCLC previously treated with one line of platinum-based therapy | Doc+Nintedanib Doc |
655 659 |
4.9 1.5 |
3.4 2.7 |
HR=0.79 (0.68–0.92) P=0.0019 |
10.1 9.1 |
HR=0.94 (0.83–1.05) P=0.2720 |
NCT00806819 (LUME-lung2) | Stage IIIB/IV or Recurrent NSCLC After failure of First Line Chemotherapy | Pem+Nintedanib Pem+Placebo |
353 360 |
9.1 8.3 |
4.4 3.6 |
HR=0.83 (0.70–0.99) P=0.0435 |
12.0 12.7 |
HR=1.01 (0.85–1.21) P=0.8940 |
NCT02388919 (ALTER) | Stage IIIB/IV NSCLC after failure of at least two systematic chemotherapy | Anlotinib Placebo |
296 143 |
9.2 0.7 |
5.4 1.4 |
HR=0.25 (0.19–0.31) P<0.001 |
9.6 6.3 |
HR=0.68 (0.54–0.87) P=0.002 |
Abbreviations: LA, locally advanced; pts, patients; CP, carboplatin and paclitaxel; BeV, bevacizumab; PemCBev, pemetrexed plus carboplatin plus bevacizumab followed by pemetrexed plus bevacizumab; PacC, paclitaxel plus carboplatin; PacCBev, paclitaxel plus carboplatin plus bevacizumab followed by bevacizumab; PemCisBev, pemetrexed plus cisplatin plus bevacizumab; PemBev, pemetrexed plus bevacizumab; Doc, Docetaxel; Ram, ramucirumab.