Durvalumab Alone or in Combination With Novel Agents in Subjects With NSCLC
Summary
The purpose of this study is to compare the clinical activity of durvalumab alone vs durvalumab in combination with novel agents. The overall study goal is early identification of novel durvalumab combinations that are more active than durvalumab alone in the treatment of patients with unresectable, Stage III NSCLC who have not progressed after cCRT.
Timeline
- Start
- 2018-12-19
- Primary completion
- 2023-07-18
- Completion
- 2023-07-18
Outcome
Sources disagree · no verdict is set; each source's reading is shown below
paper plus monalizumab (16.9 [-0.8 to 33.4] percentage points) was not statistically significant compared with durvalumab alone. reads as missed primary endpoint PMID 40663352 ↗
release “increase in the primary endpoint of confirmed ORR for Imfinzi plus oleclumab over Imfinzi alone (30% vs. 18%)” reads as met primary endpoint astrazeneca.com ↗
release “COAST Phase II trial showed oleclumab or monalizumab in combination with Imfinzi significantly delayed disease progression and increased objective response rate” reads as met primary endpoint astrazeneca.com ↗
Publications
- Aggarwal C, Martinez-Marti A, Majem M, Barlesi F, Carcereny E, Chu Q, Monnet I, Sanchez-Hernandez A, Dakhil S, Camidge DR, Pillet M, Brown M, Paliompeis C, Dowson A, Cooper ZA, Kumar R, Herbst RS. Durvalumab Alone or Combined With Novel Agents for Unresectable Stage III Non-Small Cell Lung Cancer: Update From the COAST Randomized Clinical Trial. JAMA Netw Open. 2025 Jul 1;8(7):e2518440. doi: 10.1001/jamanetworkopen.2025.18440.
- Herbst RS, Majem M, Barlesi F, Carcereny E, Chu Q, Monnet I, Sanchez-Hernandez A, Dakhil S, Camidge DR, Winzer L, Soo-Hoo Y, Cooper ZA, Kumar R, Bothos J, Aggarwal C, Martinez-Marti A. COAST: An Open-Label, Phase II, Multidrug Platform Study of Durvalumab Alone or in Combination With Oleclumab or Monalizumab in Patients With Unresectable, Stage III Non-Small-Cell Lung Cancer. J Clin Oncol. 2022 Oct 10;40(29):3383-3393. doi: 10.1200/JCO.22.00227. Epub 2022 Apr 22.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Durvalumab | Monoclonal antibody | — | Intravenous |
| Subject | Monalizumab | Monoclonal antibody | — | Intravenous |
| Subject | Oleclumab | Monoclonal antibody | — | Intravenous |