NCT04392505: DART

Durvalumab(MEDI4736) After chemoRadioTherapy(DART) for NSCLC-a Translational and Biomarker Study

Active, enrolled Phase 2 Last updated 29 February 2024

What this trial tests

Phase 2 trial testing Durvalumab Injection in Cancer in 100 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

11 May 2020

Primary endpoint
1 May 2025

1 May 2033

Quick facts

Lead sponsor	Oslo University Hospital
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	100
Start date	11 May 2020
Primary completion	1 May 2025
Estimated completion	1 May 2033
Sites	10 locations across Finland, Estonia, Lithuania, Norway

Drugs / interventions tested

• Durvalumab Injection

Conditions studied

• Cancer — all drugs for Cancer →
• Non Small Cell Lung Cancer — all drugs for Non Small Cell Lung Cancer →
• Non Small Cell Lung Cancer Stage III — all drugs for Non Small Cell Lung Cancer Stage III →
• NSCLC — all drugs for NSCLC →

Sponsor

Oslo University Hospital

Who can join

18 and older, any sex, with Cancer or Non Small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The main aim is to identify and describe biomarkers in different sample types related to chemoradiation followed by durvalumab treatment for stage III PD-L1 negative and positive non-small cell lung cancer (NSCLC) patients' eligible for curatively intended chemoradiation.

The hypothesis is that clinical differences in course of disease reflect underlying biological characteristics.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. NSCLC: from tumorigenesis, immune checkpoint misuse to current and future targeted therapy.
   Raskova Kafkova L, Mierzwicka JM, Chakraborty P, Jakubec P, et al · · 2024 · cited 31× · PMID 38384472 · DOI 10.3389/fimmu.2024.1342086
2. MicroRNA in lung cancer-a novel potential way for early diagnosis and therapy.
   Frydrychowicz M, Kuszel Ł, Dworacki G, Budna-Tukan J. · · 2023 · cited 24× · PMID 36821071 · DOI 10.1007/s13353-023-00750-2
3. Novel insights on gut microbiota manipulation and immune checkpoint inhibition in cancer (Review).
   Vivarelli S, Falzone L, Leonardi GC, Salmeri M, et al · · 2021 · cited 21× · PMID 34396439 · DOI 10.3892/ijo.2021.5255
4. A narrative review from gut to lungs: non-small cell lung cancer and the gastrointestinal microbiome.
   Shah H, Ng TL. · · 2023 · cited 17× · PMID 37197624 · DOI 10.21037/tlcr-22-595
5. The Evolving Role of PD-L1 Inhibition in Non-Small Cell Lung Cancer: A Review of Durvalumab and Avelumab.
   Neumann M, Murphy N, Seetharamu N. · · 2022 · cited 10× · PMID 35253011
6. Factors associated with failure to start consolidation durvalumab after definitive chemoradiation for locally advanced NSCLC.
   Langberg CW, Horndalsveen H, Helland Å, Haakensen VD. · · 2023 · cited 3× · PMID 37476372 · DOI 10.3389/fonc.2023.1217424
7. How does pulmonary function impact QoL in patients with locally advanced NSCLC treated with chemoradiotherapy and durvalumab?
   Sommervoll FÅ, Horndalsveen H, Sommervoll DE, Koivonen J, et al · · 2026 · PMID 41854264 · DOI 10.2340/1651-226x.2026.45040
8. Blood-based tumor mutational burden as a biomarker in unresectable non-small cell lung cancer treated with chemoradiotherapy and durvalumab.
   Horndalsveen H, Haakensen VD, Madebo T, Grønberg BH, et al · · 2025 · PMID 41199847 · DOI 10.3389/fonc.2025.1681420