Selected ongoing phase III trials evaluating neoadjuvant, perioperative, and adjuvant chemoimmunotherapy in resectable NSCLC
| Trial | Patient population | Treatment | Primary endpoint | Study completion |
|---|---|---|---|---|
| MERMAID-1 (NCT04385368) | Stage II/III NSCLC after resection | Adjuvant durvalumab or placebo plus chemotherapy for 12 weeks followed by durvalumab or placebo for up to week 48 | DFS in the MRD+ (measured by whole exome sequencing-based ctDNA test) group | 2023-8-31 |
| ANVIL (NCT02595944) | Stage IB (≥ 4 cm)–IIIA NSCLC after resection | Adjuvant nivolumab or observation | OS and DFS | 2025-12-31 |
| LungMate-008 (NCT04772287) | Stage II–IIIB (N2) NSCLC after resection | Adjuvant toripalimab or placebo with chemotherapy followed by 4 cycles adjuvant toripalimab or placebo | DFS | 2027-12-30 |
| ADOPT-lung (NCT06284317) | Resectable IIB–IIIB (N2) | Adjuvant durvalumab for 12 cycles or observation | DFS | 2030-03 |
| NADIM-ADJUVANT (NCT04564157) | Stage IB–IIIA NSCLC after resection | Adjuvant nivolumab with chemotherapy followed by 6-month of nivolumab vs. adjuvant chemotherapy | DFS | 2031-04-01 |
| IMpower 030 (NCT03456063) | Resectable stage II, IIIA, or select IIIB | Four cycles of neoadjuvant atezolizumab with chemotherapy and up to 16 cycles of adjuvant atezolizumab or placebo with chemotherapy | EFS | 2025-01-19 |
| PROSPECT LUNG (NCT06632327) | Resectable stage IIA to IIIB | Neoadjuvant ICI with 4 cycles of chemotherapy and one year adjuvant ICI vs. adjuvant therapy with 4 cycles chemotherapy and one year ICI | 3-year real-world event-free survival (rwEFS) and OS | 2030-04-30 |
| CLEAR-INSIGHT (INSIGHT: NCT06498635) | Stage II–IIIB after resection | SOC neoadjuvant platinum-based chemotherapy and anti-PD-(L)1 therapy then surgerypCR: adjuvant durvalumab for 12 cycles vs. observation (INSIGHT)Non-pCR: adjuvant durvalumab and novel inhibitor combination vs. durvalumab for one year | DFS (INSIGHT) | 2039-07-15 (INSIGHT) |
MRD: minimal residual disease; PD-1: programmed death 1; PD-L1: programmed death 1 ligand; ctDNA: circulating tumor DNA; EFS: event free survival; ICI: immune checkpoint inhibitors; NSCLC: non-small cell lung cancer; OS: overall survival; pCR: pathological complete response