For Healthcare Professionals

A Global Study to Assess the Effects of Durvalumab + Domvanalimab Following Concurrent Chemoradiation in Participants With Stage III Unresectable NSCLC

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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

INCLUSION CRITERIA:

  1. Participant must be ≥ 18 years at the time of screening.
  2. Histologically- or cytologically-documented NSCLC and have been treated with concurrent CRT for locally advanced, unresectable (Stage III) disease
  3. Provision of a tumour tissue sample obtained prior to CRT
  4. Documented tumour PD-L1 status ≥ 1% by central lab
  5. Documented EGFR and ALK wild-type status (local or central).
  6. Patients must not have progressed following definitive, platinum-based, concurrent chemoradiotherapy
  7. Participants must have received at least 2 cycles of platinum-based chemotherapy concurrent with radiation therapy
  8. 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.
  9. WHO performance status of 0 or 1 at randomization
  10. Adequate organ and marrow function

EXCLUSION CRITERIA

EXCLUSION CRITERIA:

  1. 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. Exceptions include adequately resected non-melanoma skin cancer and curatively treated in situ disease, or adequately treated carcinoma in situ or Ta tumours treated with curative intent and without evidence of disease.
  2. Mixed small cell and non-small cell lung cancer histology.
  3. Participants who receive sequential (not inclusive of induction) chemoradiation therapy for locally advanced (Stage III) unresectable NSCLC.
  4. Participants with locally advanced (Stage III) unresectable NSCLC who have progressed during platinum-based cCRT.
  5. Any unresolved toxicity CTCAE >Grade 2 from the prior chemoradiation therapy (excluding alopecia).
  6. Participants with ≥ grade 2 pneumonitis from prior chemoradiation therapy.
  7. 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
  8. Active or prior documented autoimmune or inflammatory disorders (with exceptions)
  9. Active EBV infection, or known or suspected chronic active EBV infection at screening
  10. Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab.
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 1-877-240-9479Email iconEmail Study Center

Study Details


Contition

Non-Small Cell Lung Cancer

Age

18+

Phase

PHASE3

Participants Needed

860

Est. Completion Date

Aug 30, 2030

Treatment Type

INTERVENTIONAL


Sponsor

AstraZeneca

ClinicalTrials.gov NCT Identifier

NCT05211895

Study Number

D9075C00001

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