Table 2 Ongoing Neoadjuvant Clinical Trials Containing ICI Monotherapy for Patients with NSCLC
ClinicalTrials.Gov Identifier | Biomarker(s) | Regimen | Phase | Sample Size | Stage | Primary Endpoint | Estimated or Actual Study Period [reference] |
|---|---|---|---|---|---|---|---|
NCT04941417 | PD-L1 expression | PD-(L)1 inhibitor with chemotherapy | II | 60 | I (T ≥ 4 cm), IIA, IIB, IIIA, IIIB | MPR | November 24, 2020—June 30, 2023 |
NCT03197467 (NEOMUN) | PD-L1 expression | Pembrolizumab | II | 30 | II-IIIA | Adverse events, number of patients treated, clinical response, pathologic response | June 18, 2018—October 2023 |
NCT03053856 | PD-L1 expression | Pembrolizumab | II | 37 | IIIA (N2) | DFS | February 14, 2017—August 13, 2021 |
NCT04245514 | PD-L1 expression | Durvalumab | II | 90 | T1-4 > 7 N2 M0 | EFS | July 15, 2020—March 2025 |
NCT02994576 | PD-L1 expression | Atezolizumab | II | 60 | IA (≥ 2 cm)-IIIA | Rate of patients without major toxicities or morbidities | December 20, 2016—December 2022 |
NCT04047186 | PD-L1 expression | Nivolumab | II | 50 | At least one lesion is diagnosed as NSCLC from biopsy pathology. not less than two GGNs on chest CT | PRR | October 1, 2019—December 31, 2024 |
NCT04062708 (CHIO3) | PD-L1 expression | Durvalumab | II | 55 | IIIA, IIIB | N2 nodal clearance | March 10, 2021—September 2024 |
NCT04371796 | PD-L1 expression | Sintilimab | II | 20 | II-IIIA | MPR | May 10, 2020—December 30, 2021 |