AEGEAN
Perioperative durvalumab with platinum-based chemotherapy versus placebo with chemotherapy in resectable non-small-cell lung cancer
Phase 3N = 802NCT03800134
- Population
- Resectable NSCLC, stage II to IIIB (N2) by AJCC 8th edition; patients with documented EGFR or ALK alterations were excluded from the efficacy analyses
- Design
- Randomised (1:1), placebo-controlled phase 3 trial (double-blind per the 2026 report). Platinum-based chemotherapy plus durvalumab or placebo every 3 weeks for 4 cycles before surgery, then adjuvant durvalumab or placebo every 4 weeks for 12 cycles. Randomisation stratified by stage (II or III) and PD-L1 expression (1% or more, or less than 1%). Efficacy was analysed in a modified intention-to-treat population that excluded 62 patients with documented EGFR or ALK alterations.
- Primary endpoint
- EFS, pCR
- Arms
- Durvalumab plus chemotherapy (experimental, n = 400): Platinum-based chemotherapy plus durvalumab for 4 cycles before surgery, then adjuvant durvalumab for 12 cycles
- Placebo plus chemotherapy (control, n = 402): Platinum-based chemotherapy plus placebo for 4 cycles before surgery, then adjuvant placebo for 12 cycles
- People
- Heymach JV, AEGEAN Investigators
EFSHR 0.68 (95% CI 0.53–0.88)Δ 12-month EFS+8.9 pointsΔ pCR+12.9 pointsEFSHR 0.69 (95% CI 0.55–0.88)DFSHR 0.66 (95% CI 0.47–0.92)OSHR 0.89 (95% CI 0.70–1.14)
Show the numbers
| Endpoint | Analysis | Durvalumab plus chemotherapy | Placebo plus chemotherapy | Effect |
|---|---|---|---|---|
| EFSModified ITT (patients with documented EGFR or ALK alterations excluded)Time to the earliest of progressive disease that precluded or prevented completion of surgery, disease recurrence (blinded independent central review), or death from any cause | interimHeymach 2023 | 73.4% at 12 mo (67.9–78.1%) | 64.5% at 12 mo (58.8–69.6%) | HR 0.68 (95% CI 0.53–0.88)P=0.004Primary endpoint. Maximum grade 3 or 4 adverse events 42.4% vs 43.2%. |
| pCRModified ITT (patients with documented EGFR or ALK alterations excluded) | interimHeymach 2023 | 17.2% | 4.3% | P<0.001Primary endpoint. Percentages are from the final pCR analysis; the abstract gives P<0.001 for the interim analysis of data from 402 patients, with a difference of 13.0 percentage points (95% CI 8.7 to 17.6). |
| EFSModified ITT (n = 740; patients with documented EGFR or ALK alterations excluded) | interimmedian follow-up 25.9 monthsHeymach 2026 | — | — | HR 0.69 (95% CI 0.55–0.88)Second planned interim analysis. The 25.9 months is the median follow-up of censored patients. |
| DFSResected subpopulation of the modified ITT population | interimmedian follow-up 25.9 monthsHeymach 2026 | — | — | HR 0.66 (95% CI 0.47–0.92)Interim disease-free survival; the abstract describes it as a numerical improvement. |
| OSModified ITT (n = 740; patients with documented EGFR or ALK alterations excluded) | interimmedian follow-up 25.9 monthsHeymach 2026 | — | — | HR 0.89 (95% CI 0.70–1.14)Interim overall survival; the confidence interval includes 1.14 and the abstract describes the result as a numerical improvement favouring durvalumab. |
| Endpoint | Analysis | Durvalumab plus chemotherapy | Placebo plus chemotherapy | Effect |
|---|---|---|---|---|
| EFSModified ITT (patients with documented EGFR or ALK alterations excluded)Time to the earliest of progressive disease that precluded or prevented completion of surgery, disease recurrence (blinded independent central review), or death from any cause | interimHeymach 2023 | 73.4% at 12 mo (67.9–78.1%) | 64.5% at 12 mo (58.8–69.6%) | HR 0.68 (95% CI 0.53–0.88)P=0.004Primary endpoint. Maximum grade 3 or 4 adverse events 42.4% vs 43.2%. |
| pCRModified ITT (patients with documented EGFR or ALK alterations excluded) | interimHeymach 2023 | 17.2% | 4.3% | P<0.001Primary endpoint. Percentages are from the final pCR analysis; the abstract gives P<0.001 for the interim analysis of data from 402 patients, with a difference of 13.0 percentage points (95% CI 8.7 to 17.6). |
| EFSModified ITT (n = 740; patients with documented EGFR or ALK alterations excluded) | interimmedian follow-up 25.9 monthsHeymach 2026 | — | — | HR 0.69 (95% CI 0.55–0.88)Second planned interim analysis. The 25.9 months is the median follow-up of censored patients. |
| DFSResected subpopulation of the modified ITT population | interimmedian follow-up 25.9 monthsHeymach 2026 | — | — | HR 0.66 (95% CI 0.47–0.92)Interim disease-free survival; the abstract describes it as a numerical improvement. |
| OSModified ITT (n = 740; patients with documented EGFR or ALK alterations excluded) | interimmedian follow-up 25.9 monthsHeymach 2026 | — | — | HR 0.89 (95% CI 0.70–1.14)Interim overall survival; the confidence interval includes 1.14 and the abstract describes the result as a numerical improvement favouring durvalumab. |
Data table
| Endpoint | HR | 95% CI |
|---|---|---|
| EFS | 0.68 | 0.53–0.88 |
| EFS | 0.69 | 0.55–0.88 |
| DFS | 0.66 | 0.47–0.92 |
| OS | 0.89 | 0.7–1.14 |
Appears in
Sources
Heymach JV, Harpole D, Mitsudomi T, Taube JM, Galffy G, Hochmair M, et al. Perioperative Durvalumab for Resectable Non-Small-Cell Lung Cancer. N Engl J Med. 2023;389(18):1672-1684.
Heymach JV, He J, Harpole D, Mitsudomi T, Taube JM, Gao S, et al. Perioperative Durvalumab for Resectable Non-Small Cell Lung Cancer: Updated Outcomes From the Phase III AEGEAN Trial. J Clin Oncol. 2026;:JCO2502659.