Status:
RECRUITING
A Global Study to Assess the Effects of Durvalumab + Domvanalimab Following Concurrent Chemoradiation in Participants With Stage III Unresectable NSCLC
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Arcus Biosciences, Inc.
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 du...
Eligibility Criteria
Inclusion
- 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.
- WHO performance status of 0 or 1 at randomization
- Adequate organ and marrow function
- EXCLUSION CRITERIA:
- History of another primary malignancy, except for:
- Malignancies treated with curative intent and adequate follow-up with no known active disease and have not required active treatment within the past 3 years before the first dose of study intervention and of low potential risk of recurrence.
- Adequately resected non melanoma skin cancer or lentigo maligna without evidence of disease .
- Adequately treated carcinoma in situ, including Ta tumors 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
- Active or prior documented autoimmune or inflammatory disorders (with exceptions)
- Active EBV infection, or known or suspected chronic active EBV infection at screening
- Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab.
Exclusion
Key Trial Info
Start Date :
February 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2030
Estimated Enrollment :
860 Patients enrolled
Trial Details
Trial ID
NCT05211895
Start Date
February 18 2022
End Date
October 1 2030
Last Update
December 23 2025
Active Locations (264)
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1
Research Site
Chandler, Arizona, United States, 85224
2
Research Site
Phoenix, Arizona, United States, 85054
3
Research Site
Fountain Valley, California, United States, 92708
4
Research Site
Santa Rosa, California, United States, 95403