Table 2. Main clinical trials in immunotherapy to NSCLC with approved by the FDA.
| Trial | Phase | Stage | Histology | PD-L1 | Trial design | Results | Approved by FDA |
|---|---|---|---|---|---|---|---|
| IMpower010 | 3 | Adjuv IB–III | NSCLC | All | Atezolizumab vs. placebo post-surgery and CT | Follow 32.2 m (HR =0.66); DFS 74.5% vs. 61.0% (24 m) (II–IIIA and PD-L1 ≥1%) | Oct/21 stage II–III NSCLC PD-L1 ≥1% |
| CheckMate 816 | 3 | Neoadj IB–IIIA | NSCLC | All | Nivolumab + CT vs. CT | EFS 31.6 vs. 20.8 m; pCR 24.0% vs. 2.2% | March 2022 stage IB–IIIA NSCLC all PD-L1 |
| PACIFIC | 3 | Adjuv UR III | NSCLC | All | Durvalumab vs. placebo post CT/RT | PFS 16.8 vs. 5.6 m; PFS 44.2 vs. 27% (18 m) | Feb/18 UR stage III post CT/RT |
| KEYNOTE-024 | 3 | Advanced stages (1L) | NSCLC | PD-L1 ≥50% | Pembrolizumab vs. CT | PFS 10.3 vs. 6 m; ORR 44.8% vs. 27.8% | Oct/16 1L advanced NSCLC PD-L1 ≥50% |
| IMpower110 | 3 | Advanced stages (1L) | NSCLC | PD-L1+ | Atezolizumab vs. CT | PFS 8.1 vs. 5 m (PD-L1 ≥50%); ORR 38.3% vs. 28.6% | May/20 1L advanced NSCLC PD-L1 ≥50% |
| EMPOWER-Lung 1 | 3 | Advanced stages (1L) | NSCLC | All | Cemiplimab vs. CT | PFS 8.2 vs. 5.7 m (PD-L1 ≥50%); ORR 39% vs. 20% | Feb/21 1L advanced NSCLC PD-L1 ≥50% |
| KEYNOTE-189 | 3 | Advanced stages (1L) | Non-Sq NSCLC | All | Pembrolizumab + CT vs. CT | PFS 8.8 vs. 4.9 m; ORR 47.6% vs. 18.9% | August/18 1L advanced non-Sq NSCLC all PD-L1 |
| KEYNOTE-407 | 3 | Advanced stages (1L) | Sq NSCLC | All | Pembrolizumab + CT vs. CT | PFS 6.4 vs. 4.8 m; ORR 57.9 vs. 38.4% | Oct/18 1L advanced Sq NSCLC all PD-L1 |
| IMpower150 | 3 | Advanced stages (1L) | Non-Sq NSCLC | All | Atezolizumab + CT vs. CT | PFS 8.3 vs. 6.8 m; ORR 63.5 vs. 48% | Dec/18 1L advanced non-Sq NSCLC all PD-L1 |
| CheckMate9LA | 3 | Advanced stages (1L) | NSCLC | All | Nivolumab + ipilimumab + CT vs. CT | OS 14.1 vs. 10.7 m (HR =0.69: 0.55–0.87) | May/20 1L advanced NSCLC all PD-L1 |
| CheckMate 017 | 3 | Advanced stages (2L) | Sq NSCLC | All | Nivolumab vs. docetaxel | OS 9.2 vs. 6 m; PFS 3.5 vs. 2.8 m | March/2015 2L advanced NSCLC all PD-L1 |
| CheckMate 057 | 3 | Advanced stages (2L) | Non-Sq NSCLC | All | Nivolumab vs. docetaxel | OS 12.2 vs. 9.4 m; PFS 2.3 vs. 4.2 m | Oct/2015 2L advanced NSCLC all PD-L1 |
| KEYNOTE-010 | 3 | Advanced stages (2L) | NSCLC | PD-L1+ | Pembrolizumab vs. docetaxel | OS 12.7 vs. 8.5 m; PFS 4.0 vs. 4.0 m | Oct/16 2L advanced NSCLC PD-L1 ≥1% |
| OAK | 3 | Advanced stages (2L) | NSCLC | All | Atezolizumab vs. docetaxel | OS 13.8 vs. 9.6 (HR =0.73: 0.62–0.87) | Oct/16 2L advanced NSCLC all PD-L1 |
NSCLC, non-small cell lung cancer; FDA, Food and Drug Administration; adjuv, adjuvant; CT, chemotherapy; DFS, disease-free survival; neoadj, neoadjuvant; EFS, event-free survival; pCR, pathological complete response; sq, squamous; UR, unresectable; RT, radiotherapy; PFS, progression-free survival; 1L, first-line; ORR, objective response rate; OS, overall survival; 2L, second-line.