Study identifier:AZ-RU-00003
ClinicalTrials.gov identifier:NCT06606847
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase II, Open-label, Multicentre, Single-arm Study of Durvalumab Plus Oleclumab in Patients With Locally Advanced, Unresectable Non-small Cell Lung Cancer Who Have Not Progressed Following Definitive, Platinum-Based Chemoradiation Therapy (LADOGA)
Non-small Cell Lung Cancer
Phase 2
No
Oleclumab, Durvalumab
All
28
Interventional
18 Years - n/a
Allocation: N/A
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Feb 2025 by AstraZeneca
AstraZeneca
-
The purpose of this Phase II, open-label, multicentre, single-arm study is to assess efficacy and safety of durvalumab (MEDI4736) in combination with oleclumab (MEDI9447) in participants with locally advanced (Stage III), unresectable non-small cell lung cancer (NSCLC), who have not progressed following platinum-based concurrent or sequential chemoradiotherapy (cCRT or sCRT).
This is a Phase II, open-label, multicentre, single-arm study assessing the efficacy and safety of durvalumab in combination with oleclumab in participants with locally advanced (Stage III), unresectable NSCLC with WHO performance status of 0 or 1, who have not progressed on prior platinum-based CRT. All participants will be assigned to receive durvalumab and oleclumab as an IV infusions for up to 12 months (last dose should be administered at week 48). The last administration at Week 48, or until clinical progression, confirmed RECIST 1.1‑defined radiological progression, unacceptable toxicity, withdrawal of consent, or an intervention discontinuation criterion is met. The results of this study will provide clinical data on efficacy and safety of an innovation treatment in the new region – Russian Federation.
Location
Location
Moscow, Russian Federation, 111123
Location
St. Petersburg, Russian Federation, 197758
Location
Moscow, Russian Federation, 115478
Location
Nizhny Novgorod, Russian Federation, 603126
Location
Novosibirsk, Russian Federation, 630108
Location
Ufa, Russian Federation, 450054
Location
Ekaterinburg, Russian Federation, 620905
Location
Obninsk, Russian Federation, 249031
Arms | Assigned Interventions |
---|---|
Experimental: Arm 1 durvalumab plus oleclumab as an IV infusions | - |
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