Table 1
Ongoing phase III trials of anti-PD-1/PD-L1 agents and combinations in Non-Small Cell Lung Cancer and Small Cell Lung Cancer.
| Agent | Clinical Setting | Comparison | Clinicaltrials. gov Identifier |
|---|---|---|---|
| Nivolumab | |||
| First line, any NSCLC histology | Vs platinum doublet (physician’s choice) | NCT02041533 | |
| First line, any NSCLC histology | 4 arms: nivolumab vs nivolumab/ipilimumab vs nivolumab/chemotherapy vs chemotherapy (platinum based doublet, physician’s choice) | NCT02477826 | |
| Second line NSCLC after platinum based doublet | Vs docetaxel | NCT02613507 | |
| Adjuvant treatment NSCLC after resection and chemotherapy | Vs placebo | NCT02595944 | |
| Relapsed SCLC | Vs topotecan or amrubicin | NCT02481830 | |
| Extensive SCLC, maintenance after first line treatment | nivolumab vs nivolumab/ipilimumab vs placebo | NCT02538666 | |
| Pembrolizumab | |||
| Adjuvant treatment NSCLC after resection with or without chemotherapy | Vs placebo | NCT02504372 | |
| First line, any NSCLC histology, PD-L1 positive | Vs platinum based doublet chemotherapy | NCT02220894 | |
| First line, any NSCLC histology | Vs platinum based doublet chemotherapy | NCT02142738 | |
| First line, any NSCLC histology | Platinum/pemetrexed, with or without pembrolizumab | NCT02578680 | |
| Atezolizumab | |||
| First line, non-squamous NSCLC | Platinum/pemetrexed, with or without atezolizumab | NCT02657434 | |
| First line, squamous NSCLC | Carboplatin/taxane with or without atezolizumab | NCT02367794 | |
| First line, PD-L1 positive squamous NSCLC | Vs platinum/gemcitabine | NCT02409355 | |
| First line, PD-L1 positive non-squamous NSCLC | Vs platinum/pemetrexed | NCT02409342 | |
| First line, non-squamous NSCLC | 3 arms: paclitaxel/carboplatin/atezolizumab vs paclitaxel/carboplatin/bevacizumab vs paclitaxel/ carboplatin/bevacizumab/atezolizumab | NCT02366143 | |
| First line, non-squamous NSCLC | Carboplatin/nab-paclitaxel with or without atezolizumab | NCT02367781 | |
| Second line NSCLC after platinum based doublet | Vs docetaxel | NCT02008227 | |
| Adjuvant treatment NSCLC after resection and chemotherapy | Vs placebo | NCT02486718 | |
| Durvalumab | |||
| First line, any NSCLC histology | Durvalumab vs durvalumab/tremelimumab vs platinum based doublet | NCT02453282 | |
| Stage III NSCLC following chemoradiotherapy | Vs placebo | NCT02125461 | |
| Adjuvant treatment NSCLC after resection and chemotherapy | Vs placebo | NCT02273375 | |
| Third line NSCLC | Durvalumab vs durvalumab/tremelimumab vs monotherapy (gemcitabine, vinorelbine or erlotinib) | NCT02352948 | |
Table 2
Published trials in full form of PD-1 inhibitors.
| Agent | Reference | Phase | N | Comparison/Setting | Response Rate | PFS (months) | OS (months) | Comments |
|---|---|---|---|---|---|---|---|---|
| Nivolumab | ||||||||
| Gettinger et al [15] | 1 | 129 | N/A / Heavily pretreated | 17% | 2.3 | 9.9 | ||
| Rizvi et al [16] | 2 | 117 | N/A / Heavily pretreated | 14,5% | 1.9 | 8.2 | ||
| Brahmer et al [17] | 3 | 272 | Docetaxel / 2nd line squamous | 20% vs 8% (P=0.008) | 3.5 vs 2.8 (P<0.001) | 9.2 vs 6.0 (P<0.001) | ||
| Borghaei et al [18] | 3 | 587 | Docetaxel / 2nd line non-squamous | 19% vs 12% (P=0.02) | 2.3 vs 4.2 (NS) | 12.1 vs 9.4 (P=0.002) | ||
| Pembrolizumab | Garon et al [27] | 1 | 495 | N/A / Heavily pretreated | 19,4% | 3.7 | 12.0 | |
| Herbst et al [29] | 2/3 | 1043 | Docetaxel / 2nd line PD-L1≥1% | 18% vs 9% (P=0.0002) | 4.0 vs 4.0 (NS) | 12.7 vs 8.5 (P<0.0001) | 10 mg/kg arm vs docetaxel | |
| Herbst et al [29] | 2/3 | 1043 | Docetaxel / 2nd line PD-L1≥1% | 18% vs 9% (P=0.0005) | 3.9 vs 4.0 (NS) | 10.4 vs 8.5 (P=0.0008) | 2 mg/kg arm vs docetaxel | |