Clinical trial · Interventional
Durvalumab Alone or in Combination With Novel Agents in Subjects With NSCLC
A Phase 2 Open-label, Multicenter, Randomized, Multidrug Platform Study of Durvalumab (MEDI4736) Alone or in Combination With Novel Agents in Subjects With Locally Advanced, Unresectable (Stage III) Non-small Cell Lung Cancer (COAST)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage III Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Unresectable | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Durvalumab | Drug | Durvalumab | ALIAS |
| Durvalumab + Monalizumab | Drug | — | UNRESOLVED |
| Durvalumab + Oleclumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Control Arm (Durvalumab monotherapy)
- description
- durvalumab IV
- interventionNames
- Drug: Durvalumab
- type
- EXPERIMENTAL
- label
- Arm A (durvalumab + oleclumab):
- description
- durvalumab IV and oleclumab IV
- interventionNames
- Drug: Durvalumab + Oleclumab
- type
- EXPERIMENTAL
- label
- Arm B (durvalumab + monalizumab)
- description
- durvalumab IV and monalizumab IV
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Main Inclusion Criteria: 1. Written informed consent and any locally required authorization obtained from the subject prior to performing any protocol-related procedures, including screening evaluation 2. Age 18 years or older 3. Body weight ≥ 35 kg 4. Subjects must have histologically or cytologically documented NSCLC who present with locally advanced, unresectable, Stage III disease 5. Subjects must have completed, without progressing, definitive cCRT within 42 days prior to being randomized into the study 6. Provision of tumor tissue sample, when available, from original diagnosis obtained before initiation of chemoradiotherapy 7. Life expectancy ≥ 12 weeks 8. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 9. Subjects must have at least one previously irradiated tumor lesion that can be measured by RECIST v1.1 Main Exclusion Criteria: 1. Mixed small cell and non-small cell lung cancer histology 2. Current or prior use of immunosuppressive medication within 14 days before the first dose of study drug 3. Prior exposure to any anti-PD1, anti-PD-L1, or anti-CTLA4 antibody for treatment of NSCLC 4. Subjects with history of ≥ Grade 2 pneumonitis from prior chemoradiation therapy 5. Subjects with a history of venous thrombosis within the past 3 months 6. Subjects with history of myocardial infarction, transient ischemic attack, or stroke in the past 6 months 7. Congestive heart failure 8. Active or prior documented autoimmune or inflammatory disorders 9. History of active primary immunodeficiency 10. Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) 11. History of allogenic organ transplantation 12. QTcF interval ≥ 470 ms 13. History of another primary malignancy 14. Concurrent enrollment in another clinical study \[concurrent enrollment in an observational (non-interventional) clinical study or during the follow-up period of an interventional study is permitted\] 15. Females who are pregnant, lactating, or intend to become pregnant during their participation in the study
References
Publications (2)
- DERIVEDAggarwal 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. PMID 40663352
- DERIVEDHerbst 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. PMID 35452273