Table 1.
Ongoing clinical trials that included adjuvant immunotherapy in resectable non-small cell lung cancer.
| Trial | NCT Number | Sponsor | Start date | Phase | Stage | Participants (n) | EGFR mutation/ALK rearrangement | Intervention following surgery | Primary endpoint | Completion date |
|---|---|---|---|---|---|---|---|---|---|---|
| BR31/IFCT1401 | NCT02273375 | Canadian Cancer Trials Group |
2014-10-9 | 3 | IB-IIIAAJCC 7th | 1415 | Included | Arm A: (optional chemotherapy and RT if N2) Durvalumab (1 year); arm B: (optional chemotherapy and RT if N2) placebo (1 year) | DFS | 2024-1-31 |
| IMpower010 | NCT02486718 | Hoffmann-La Roche | 2015-10-31 | 3 | IB-IIIA AJCC 7th |
1280 | Included | Arm A: cisplatin-based chemotherapy (4 cycles, Q3W) then atezolizumab (16 cycles, Q3W); arm B: cisplatin-based chemotherapy (4 cycles, Q3W) then best supportive care | DFS | 2027-12-17 |
| PEARLS/KEYNOTE-091 | NCT02504372 | Merck Sharp &Dohme LLC | 2015-11-6 | 3 | IB-IIIA AJCC 7th |
1177 | Included | Arm A: (optional chemotherapy) pembrolizumab (1 year, Q3W); arm B: (optional chemotherapy) placbo (1 year, Q3W)) | DFS | 2024-2-2 |
| ANVIL | NCT02595944 | National CancerInstitute (NCI) | 2016-5-6 | 3 | IB-IIIA AJCC 7th |
903 | Excluded | Arm A: (optional chemotherapy and RT) nivolumab (1 year, Q4W); arm B: (optional chemotherapy and RT) observation (1 year) | DFS, OS | 2024-7-1 |
| ALCHEMIST Chemo-IO | NCT04267848 | National CancerInstitute (NCI) | 2020-6-3 | 3 | IIA–IIIBAJCC 8th | 1210 | Excluded (applicable to non-squamous NSCLC) |
Arm A: platinum doublet (4 cycles, Q3W) then observation; arm B: platinum doublet (4 cycles, Q3W) then pembrolizumab 17 cycles (Q3W) or 16 cycles (Q6W, after 10/14/2020); arm C: platinum doublet plus pembrolizumab (4 cycles, Q3W) , then pembrolizumab 13 cycles (Q3W) or 12 cycles (Q6W, after 10/14/2020) |
DFS | 2024-12-15 |
| MERMAID-1 | NCT04385368 | AstraZeneca | 2020-7-17 | 3 | II-III AJCC 8th |
332 | Excluded | MRD+ patients; Arm A: Durvalumab plus SoC chemotherapy 4 cycles (Q3W), followed by 12 cycles (Q4W); arm B: placebo plus SoC chemotherapy 4 cycles (Q3W), followed by 12 cycles (Q4W) | DFS | 2026-9-30 |
| MERMAID-2 | NCT04642469 | AstraZeneca | 2020-11-30 | 3 | II-IIIAJCC 8th | 284 | Excluded |
MRD regular monitor:
MRD+ patients receive durvalumab versus placebo (2years, Q4W) |
DFS | 2027-10-29 |
| NADIMADJUVANT | NCT04564157 | Fundación GECP |
2021-1-13 | 3 | IB-IIIAAJCC 8th | 210 | Excluded | Arm A: Paclitaxel+carboplatin+nivolumab (4 cycles, Q3W) then nivolumab (6 cycles, Q4W); Arm B: Paclitaxel+carboplatin (4 cycles, Q3W) then observation | DFS | 2028-4-1 |
| LungMate-008 | NCT04772287 | Shanghai Pulmonary Hospital |
2021-3-31 | 3 | II-IIIBAJCC 8th | 341 | Excluded | Arm A: platinum doublet (4 cycles, Q3W) then toripalimab (4 cycles, Q3W); arm B: platinum doublet (4 cycles, Q3W) then placebo (4 cycles, Q3W) | DFS | 2027-12-30 |
AJCC, American Joint Committee on Cancer; ALK, anaplastic lymphoma kinase; DFS, disease-free survival; EGFR, epidermal growth factor receptor; MRD, minimal residual disease; NCT, national clinical trial; OS, overall survival; RT, radiotherapy; SoC, standard of care.