A Study to Investigate the Effects of Durvalumab With Oleclumab Following Chemoradiation in Parti… (NCT06606847) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Study to Investigate the Effects of Durvalumab With Oleclumab Following Chemoradiation in Participants With Locally Advanced Unresectable Non-Small Cell Lung Cancer (LADOGA)
Russia30 participantsStarted 2024-09-24
Plain-language 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 advanced (Stage III), unresectable non-small cell lung cancer (NSCLC), who have not progressed following platinum-based concurrent or sequential chemoradiotherapy (cCRT or sCRT).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 w…
What they're measuring
1
Progression free survival (PFS) at 12 months
Timeframe: From date of first dose until 12 months