A Global Study to Assess the Effects of Durvalumab + Domvanalimab Following Concurrent Chemoradia… (NCT05211895) | Clinical Trial Compass
RecruitingPhase 3
A Global Study to Assess the Effects of Durvalumab + Domvanalimab Following Concurrent Chemoradiation in Participants With Stage III Unresectable NSCLC
United States860 participantsStarted 2022-02-18
Plain-language summary
This is a Phase III, randomised, double-blind, placebo-controlled, multicentre, international study assessing the efficacy and safety of durvalumab (MEDI4736) and domvanalimab (AB154) compared with durvalumab plus placebo in adults with locally advanced (Stage III), unresectable NSCLC whose disease has not progressed following definitive platinum-based cCRT.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Participant must be ≥ 18 years at the time of screening.
✓. Histologically- or cytologically-documented NSCLC and have been treated with concurrent CRT for locally advanced, unresectable (Stage III) disease
✓. Provision of a tumour tissue sample obtained prior to CRT
✓. Documented tumour PD-L1 status ≥ 1% by central lab
✓. Documented EGFR and ALK wild-type status (local or central).
✓. Patients must not have progressed following definitive, platinum-based, concurrent chemoradiotherapy
✓. Participants must have received at least 2 cycles of platinum-based chemotherapy 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 randomised. Radiation therapy should be administered by intensity modulated RT (preferred) or 3D-conforming technique.
Exclusion criteria
✕. History of another primary malignancy, except for:
✕. Mixed small cell and non-small cell lung cancer histology.
✕. Participants who receive sequential (not inclusive of induction) chemoradiation therapy for locally advanced (Stage III) unresectable NSCLC.
. Participants with locally advanced (Stage III) unresectable NSCLC who have progressed during platinum-based cCRT.
✕. 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 randomisation. 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)