Table 4. Key ongoing studies of immunotherapy in early stage NSCLC.
| Trial (NCT identifier) | Phase | Stage | A/NA | Other key selection criteria* | Agent | Estimated enrollment | Primary endpoint |
|---|---|---|---|---|---|---|---|
| ANVIL (ALCHEMIST trial) (NCT02595944) | III | IB–IIIA | A | EGFR-, ALK-; PD-L1 tested | Nivolumab vs. observation | 714 | OS, DFS |
| PEARLS/KEYNOTE-091 (NCT02504372) | III | IB–IIIA | A | PD-L1 tested | Pembrolizumab vs. placebo | 1,080 | DFS |
| NCT02273375 | III | IB–IIIA | A | – | Durvalumab vs. placebo | 1,360 | DFS |
| IMpower010 (NCT02486718) | III | IB–IIIA | A | – | Atezolizumab vs. best supportive care | 1,127 | DFS |
| NCT03447769 | III | II–IIIA, resected IIIB | A | – | Canakinumab vs. placebo | 1,500 | DFS |
| NCT03148327 | I | I | A | Medically-inoperable (or surgery refused) | Phase 1: Durvalumab + SBRT; Phase 2: SBRT alone vs. durvalumab + SBRT |
105 | PFS |
| CheckMate 816 (NCT02998528) | III | IB–IIIA | NA | – | 3 arms: (I) Nivolumab + ipilimumab; (II) Nivolumab + platinum doublet chemotherapy; (III) Platinum doublet chemotherapy alone |
642 | Event-free survival; pathological complete response |
| IMpower030 (NCT03456063) | III | II–IIIA, select IIIB | NA | – | Neoadjuvant atezolizumab (or placebo) + platinum-based chemotherapy ×4 cycles, then adjuvant atezolizumab (or placebo) ×16 cycles | 302 | Major pathologic response (% with ≤10% residual viable tumor at time of resection) |
| KEYNOTE-671 (NCT03425643) | III | IIB–IIIA | NA | – | Platinum doublet chemotherapy + pembrolizumab/placebo (×4 cycles neoadjuvant + 13 cycles adjuvant) | 786 | Event-free survival |
| TOP1501** (NCT02259621) | II | IB–IIA | NA | – | Pembrolizumab then surgery followed by adjuvant chemotherapy + pembrolizumab | 32 | Surgical feasibility rate |
| NEOSTAR (NCT03158129) | II | I–IIIA | NA | – | 3 arms: (I) nivolumab; (II) nivolumab + ipilimumab; (III) nivolumab + platinum doublet chemotherapy |
66 | Major pathologic response (% w ≤10% residual viable tumor at time of resection) |
| NCT03081689** | II | IIIA | NA | – | Nivolumab + platinum doublet chemotherapy | 46 | Progression free survival |
| IONESCO** (NCT03030131) | II | IB–II | NA | No prior neoadjuvant chemotherapy or radiotherapy | Durvalumab ×3 cycles | 81 | Percentage of surgical resection R0 |
| LCMC3** (NCT02927301) | II | IB–IIA, selected IIB resectable | NA | – | Atezolizumab ×2 cycles then adjuvant atezolizumab for 12 months | 180 | Major pathologic response |
| PRINCEPS (NCT02994576) | II | IB–IIIA | NA | – | Atezolizumab ×1 | 60 | Rate of patients without major toxicities or morbidities from treatment to 1 month after surgery |
| NCT02716038** | II | IB–IIIA | NA | – | Atezolizumab + platinum doublet chemotherapy | 60 | DFS |
| NCT02904954 | II | I–IIIA | NA | – | Arm 1: Durvalumab ×2 cycles; Arm 2: Durvalumab ×2 cycles + SBRT |
– | – |
| NCT02572843** | II | IIIA | NA | – | Durvalumab ×3 cycles following cisplatin/docetaxel ×2 cycles, then adjuvant durvalumab ×1 yr (following radiotherapy in subset with incomplete resection) | Event-free survival at 12 months | |
*, for the adjuvant studies when not specifically indicated, routine adjuvant chemotherapy permitted prior to study entry; **, indicates single-arm study. NSCLC, non-small cell lung cancer; DFS, disease-free survival; EGFR, epidermal growth factor receptor; ALK, anaplastic lymphoma kinase; PD-L1, programmed death-ligand 1; OS, overall survival; PFS, progression-free survival; SBRT, stereotactic body radiation therapy.