Status:
ACTIVE_NOT_RECRUITING
A Study to Investigate the Effects of Durvalumab With Oleclumab Following Chemoradiation in Participants With Locally Advanced Unresectable Non-Small Cell Lung Cancer (LADOGA)
Lead Sponsor:
AstraZeneca
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
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), unresecta...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Participant must be ≥ 18 years at the time of screening.
- Histologically-documented NSCLC and have been treated with concurrent or sequential CRT for locally advanced, unresectable (Stage III) disease.
- Documented tumour PD-L1 status by qualified lab (local or central).
- Documented EGFR and ALK wild-type status (local or central).
- Patients must not have progressed following definitive, platinum based, concurrent or sequential chemoradiotherapy.
- Participants must have received at least 2 cycles of platinum-based chemotherapy before or concurrent with radiation therapy.
- Participants must have received a total dose of radiation of 60 Gy ±10% (54 Gy to 66 Gy) as part of the chemoradiation therapy, to be enrolled. Radiation therapy should be administered by intensity modulated RT/volumetric modulated arc therapy (preferred) or 3D-conforming technique.
- WHO performance status of 0 or 1.
- Adequate organ and marrow function.
- EXCLUSION CRITERIA:
- History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥5 years before the first dose of study intervention and of low potential risk for recurrence, adequately resected non-melanoma skin cancer and curatively treated in situ disease, or adequately treated carcinoma in situ or Ta tumours without evidence of disease.
- Mixed small cell and non-small cell lung cancer histology.
- Participants with locally advanced (Stage III) unresectable NSCLC who have progressed during platinum-based CRT.
- Any unresolved toxicity CTCAE \>Grade 2 from the prior chemoradiation therapy (excluding alopecia).
- Participants with ≥grade 2 pneumonitis from prior chemoradiation therapy.
- History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, or idiopathic pneumonitis - regardless of time of onset prior to study treatment assignment. Evidence of active non-CRT induced pneumonitis (≥ Grade 2), active pneumonia, active ILD, active or recently treated pleural effusion, or current pulmonary fibrosis.
- Active or prior documented autoimmune or inflammatory disorders (with exceptions).
- Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab.
Exclusion
Key Trial Info
Start Date :
September 24 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06606847
Start Date
September 24 2024
End Date
June 30 2027
Last Update
December 19 2025
Active Locations (11)
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1
Research Site
Kazan', Russia, 420029
2
Research Site
Moscow, Russia, 111123
3
Research Site
Moscow, Russia, 115478
4
Research Site
Moscow, Russia, 143423