Table 2. Select neoadjuvant immunotherapy trials for the treatment of operable NSCLC.
| Trial identifier (estimated primary completion) | Study name and sponsor | Phase | Intervention | Estimated enrollment | Stage | Primary endpoints |
|---|---|---|---|---|---|---|
| Immunotherapy monotherapy | ||||||
| ChiCTR-OIC-17013726 (~2019) | National Cancer Center, Beijing (China) | IB | Sintilimab (single arm) | 30 | IB–IIA squamous | Efficacy and safety |
| NCT02818920 (Mar. 2019) | TOP1501, Duke University (USA) | II | Pembrolizumab (single arm) | 32 | IB–IIIA | Surgical feasibility rate |
| NCT02994576 (Dec. 2019) | PRINCEPS, Gustave Roussy (France) | II | Atezolizumab (single arm) | 60 | IB–IIIA (non-N2) | Safety |
| NCT03197467 (Feb. 2020) | NEOMUN, AIO-Studien-gGmbH (Germany) | II | Pembrolizumab (single arm) | 30 | II–IIIA | Safety, clinical and pathological responses |
| NCT02927301 (Feb. 2020) | LCMC3, Genentech Inc. (USA) | II | Atezolizumab (single arm) | 180 | IB–IIIB | MPR |
| NCT03030131 (Dec. 2022) | IONESCO, IFCT (France) | II | Durvalumab (single arm) | 81 | IB–IIB | R0 resection feasibility |
| Combination immunotherapies | ||||||
| NCT03794544 (Mar. 2022) | NeoCOAST, MedImmune LLC (USA) | II | Durvalumab vs. durvalumab + oleclumab or monalizumab or danvatirsen (four arms) | 160 | I–IIIA | MPR |
| NCT02259621 (Jan. 2023) | SKCCC at JH (USA) | II | Nivolumab vs. nivolumab + ipilimumab | 30 | High risk IB–IIIA | Safety |
| Combination immunotherapy and chemotherapy | ||||||
| NCT02716038 (Apr. 2020) | Columbia University (USA) | II | Atezolizumab + chemotherapy (single arm) | 30 | IB–IIIA | MPR |
| NCT02998528 (Apr. 2020) | CheckMate 816, BMS (USA) | III | Nivolumab + ipilimumab vs. nivolumab + chemotherapy vs. chemotherapy alone | 350 | IB–IIIA | EFS, pCR |
| NCT03800134 (Jul. 2020) | AEGEAN, AstraZeneca (USA) | III | Durvalumab + chemotherapy vs. chemotherapy | 300 | II–III | MPR |
| NCT02572843 (Mar. 2021) | Swiss Group for Clinical Cancer Research (Switzerland) | II | Durvalumab + chemotherapy (single arm) | 68 | IIIA (N2) | EFS |
| NCT03081689 (Jun. 2021) | NADIM, Spanish Lung Cancer Group (Spain) | II | Nivolumab + chemotherapy (single-arm) | 46 | IIIA (N2) | PFS |
| NCT03158129 (Jul. 2021) | NEOSTAR, MDACC (USA) | II | Nivolumab vs. nivolumab + ipilimumab vs. nivolumab + chemotherapy | 66 | I–IIIA | MPR |
| NCT03366766 (Jul. 2021) | SKCCC at JH (USA) | II | Nivolumab + histology-specific chemotherapy | 34 | I–IIIA | MPR |
| NCT03838159 (Mar. 2022) | NADIM II, Fundación GECP (Spain) | II | Nivolumab + chemotherapy vs. chemotherapy | 90 | IIIA–IIIB (T3N2) | pCR |
| NCT03425643 (Jan. 2024) | KEYNOTE-671, Merck (USA) | III | Pembrolizumab + chemotherapy vs. placebo + chemotherapy | 786 | II–IIIB (N2) | EFS, OS |
| NCT03456063 (Mar. 2025) | IMpower030, Hoffmann-La Roche (USA) | III | Atezolizumab + chemotherapy vs. placebo + chemotherapy | 374 | II–IIIB (T3N2) | EFS, MPR |
| Combination immunotherapy and radiotherapy | ||||||
| NCT02904954 (Jan. 2020) | Weill Medical College of Cornell University (USA) | II | Durvalumab vs. durvalumab + radiation (SBRT) | 60 | I–IIIA | DFS |
| NCT03217071 (Sep. 2020) | PembroX, UCSF (USA) | II | Pembrolizumab vs. pembrolizumab + radiation (SRT) | 40 | I–IIIA | Change in number of infiltrating CD3+ T cells |
| NCT03237377 (Sep. 2021) | SKCCC at JH (USA) | II | Durvalumab + radiation vs. durvalumab + tremelimab + radiation | 32 | III | Safety and feasibility |
NSCLC, non-small cell lung cancer; BMS, Bristol-Myers Squibb; DFS, disease-free survival; EFS, event-free survival; JH, Johns Hopkins; MDACC, MD Anderson Cancer Centre; MPR, major pathological response; OS, overall survival; pCR, pathological complete response; PFS, progression-free survival; SKCCC, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; IFCT, Intergroupe Francophone de Cancérologie Thoracique; SBRT, stereotactic body radiation therapy; UCSF, University of California at San Francisco.