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Active (not recruiting) Phase 3 NCT05221840

A Global Study to Assess the Effects of Durvalumab With Oleclumab or Durvalumab With Monalizumab Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer

Phase 3 – large-scale trial before approval
Conditions: Non-Small Cell Lung Cancer

Sponsor: AstraZeneca

trial.available_in: БГ
Overview
This is a Phase III, randomised, double-blind, multicentre, international study assessing the efficacy and safety of durvalumab (MEDI4736) in combination with oleclumab (MEDI9447) or durvalumab (MEDI4736) with monalizumab (IPH2201) in adults with locally advanced (Stage III), unresectable NSCLC, who have not progressed following platinum-based cCRT.
Who can participate
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 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. * WHO performance status of 0 or 1 at randomization * 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 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 - diagnosed in the past 6 months prior to randomization. * 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.
Locations 19
Australia (1)
Research Site
Box Hill
Brazil (1)
Research Site
Barretos
Canada (1)
Research Site
Edmonton , Alberta
China (1)
Research Site
Anyang
Colombia (1)
Research Site
Barranquilla
France (1)
Research Site
Avignon
Germany (1)
Research Site
Erfurt
Italy (1)
Research Site
Brescia
Japan (1)
Research Site
Himeji-shi
Peru (1)
Research Site
Lima
Poland (1)
Research Site
Bydgoszcz
South Korea (1)
Research Site
Changwon-si
Spain (1)
Research Site
Barcelona
Taiwan (1)
Research Site
Hsinchu
Thailand (1)
Research Site
Bangkok
Turkey (1)
Research Site
Ankara
United Kingdom (1)
Research Site
Belfast
United States (1)
Research Site
San Diego , California
Vietnam (1)
Research Site
Haiphong
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
07.02.2022
Completion date
02.07.2030
Registry ID
NCT05221840
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.