Table 1.
Summary of ongoing and planned key durvalumab trials in early-stage lung cancer
| Diagnosis and staging | Setting | Trial | Patient population | Estimated (or actual) enrollment | Design | Primary end points |
|---|---|---|---|---|---|---|
| Resectable Stage I–III NSCLC | Neoadjuvant | NeoCOAST [64, 65] (NCT03794544) | Stage I (> 2 cm) to IIIA | 80 |
Phase 2, open-label, randomized, multicenter, multidrug platform trial Arm A: Durvalumab Arm B: Durvalumab + oleclumab Arm C: Durvalumab + monalizumab Arm D: Durvalumab + danvatirsen |
mPR |
| Neoadjuvant/ adjuvant | AEGEAN [66, 67 Data on file] (NCT03800134) | Stage IIA to select (i.e., N2) Stage IIIB | 800 |
Phase 3, double-blind, randomized, international trial Arm 1: Neoadjuvant platinum doublet CT + durvalumab, with adjuvant durvalumab Arm 2: Neoadjuvant platinum doublet CT + placebo, with adjuvant placebo |
pCR EFS |
|
| Adjuvant |
BR.31 [68] (NCT02273375) Partnered (CCTG) |
Stage IB (≥ 4 cm in the longest diameter) to IIIAa |
1360 |
Phase 3, double-blind, randomized, international trial Arm 1: Durvalumab (after optional SOC adjuvant platinum doublet CT) Arm 2: Placebo (after optional SOC adjuvant platinum doublet CT) |
DFS in patients with PD-L1 TC ≥ 25% and ≥ 1% DFS in all patients |
|
| MERMAID-1 [69] (NCT04385368) | Stage II–III | 332 |
Phase 3, double-blind, randomized, international trial Arm 1: Adjuvant SOC platinum-based CT + durvalumab, followed by durvalumab Arm 2: Adjuvant SOC platinum-based CT + placebo, followed by placebo |
DFS in MRD+ patients | ||
| MERMAID-2 [70] (NCT04642469) | Stage II–III | 284 |
Phase 3, double-blind, randomized, international trial Arm 1: Adjuvant durvalumab after local SOC curative intent therapyb Arm 2: Adjuvant placebo after local SOC curative intent therapyb |
DFS in patients with PD-L1 TC ≥ 1% | ||
| Inoperable Stage I/II NSCLC | Concurrent with SBRT | PACIFIC-4 [71, 72] (NCT03833154) | Lymph-node negative | 706 |
Phase 3, double-blind, randomized, international trial Arm 1: Definitive SOC SBRT + durvalumab, followed by durvalumab Arm 2: Definitive SOC SBRT + placebo, followed by placebo |
PFS |
| Unresectable Stage III NSCLC | Following CRT | PACIFIC [11–14] (NCT02125461) | No progression after cCRT | 713 |
Phase 3, randomized, double-blind, placebo-controlled trial Arm 1: Durvalumab Arm 2: Placebo |
PFS OS |
| PACIFIC-5 [73, 74] (NCT03706690) | No progression after cCRT or sCRT | 360 |
Phase 3, double-blind, randomized, international trial Arm 1: Durvalumab Arm 2: Placebo |
PFS | ||
| PACIFIC-6 [75, 76] (NCT03693300) | No progression after sCRT | 120 |
Phase 2, open-label, international study Cohort 1 (WHO/ECOG PS 0–1; n ~ 100–120): durvalumab Cohort 2 (WHO/ECOG PS 2; n ≤ 30): durvalumab |
Grade 3/4 TRAE rate within 6 months | ||
| COAST [77, 78] (NCT03822351) | No progression after cCRT | 189 |
Phase 2, open-label, randomized, multicenter, multidrug platform trial Control arm: Durvalumab Arm A: Durvalumab + oleclumab Arm B: Durvalumab + monalizumab |
ORR | ||
| Concurrent with CRT | PACIFIC-2 [79, 80] (NCT03519971) | No prior or current cancer Tx | 328 |
Phase 3, double-blind, randomized, international trial Arm 1: Durvalumab + SOC platinum-based cCRT, followed by durvalumabc Arm 2: Placebo + SOC platinum-based cCRT, followed by placeboc |
PFS | |
| Following RT | DUART [81] (NCT04249362) | CT-ineligible with no progression after RT | 150 |
Phase 2 open-label, single-arm, multicenter, international study Cohort A: Durvalumab (following standard RT) Cohort B: Durvalumab (following palliative RT) |
Grade 3/4 PRAE rate | |
| Limited Stage SCLC | Following cCRT | ADRIATIC [82, 83] (NCT03703297) | No progression after cCRT | 724 |
Phase 3, double-blind, randomized, international trial Arm 1: Durvalumab Arm 2: Durvalumab + tremelimumab Arm 3: Placebo |
PFS OS |
The current status of each trial (i.e., recruitment status and estimated primary completion date) can be obtained by accessing its study record on the ClinicalTrials.gov registry using its unique NCT number
CCTG Canadian Cancer Trials Group, (c)CRT (concurrent) chemoradiotherapy, CR complete response, CT chemotherapy, DFS disease-free survival, ECOG Eastern Cooperative Oncology Group, EFS event-free survival, G3/4 grade 3 or 4, IASLC International Association for the Study of Lung Cancer, mPR major pathologic response, MRD minimal residual disease, NSCLC non-small cell lung cancer, ORR objective response rate, OS overall survival, pCR pathologic complete response, PFS progression-free survival, PR partial response, PRAE possibly related adverse event, PS performance status, RT radiation therapy, SBRT stereotactic body radiation therapy, SCLC small cell lung cancer, SD stable disease, SOC standard of care, TRAE treatment-related adverse event, Tx treatment, WHO World Health Organization
aAlthough T3N2M0 tumors have been reclassified to Stage IIIB in the 8th edition of the IASLC staging system, these patients remain eligible (as Stage IIIA under the 7th edition criteria)
bComplete resection ± neoadjuvant and/or adjuvant therapy
cConsolidation treatment in patients with CR, PR or SD only