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ACTIVE NOT RECRUITINGPhase3

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

Sponsor: AstraZeneca

NCT ID: NCT05211895

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Durvalumab (drug), Domvanalimab (drug), Placebo (other)
How long the study runs
Study runs about 67 months (dates as stated)
About the drug or intervention
Durvalumab — drug: Durvalumab IV (Intravenous infusion) · Domvanalimab — drug: Domvanalimab IV (Intravenous infusion) · Placebo — other: Placebo IV (Intravenous infusion)
Patient visit burden
Not specified by the sponsor

In plain English

This study looks at two medicines, durvalumab and domvanalimab, for people with stage III non-small cell lung cancer (NSCLC) that cannot be removed by surgery. Everyone in the study has already had chemotherapy given at the same time as radiotherapy. The study is run by AstraZeneca.

Who can take part

  • Adults aged 18 or over
  • Diagnosed with non-small cell lung cancer that is stage III and cannot be removed by surgery, already treated with chemotherapy and radiotherapy given at the same time
  • A tumour tissue sample given before chemoradiotherapy
  • Tumour PD-L1 level of 1% or more, confirmed by a central laboratory
  • Cancer does not have EGFR or ALK changes (called 'wild-type')
  • No signs the cancer has grown after finishing chemoradiotherapy
  • Received at least 2 cycles of platinum-based chemotherapy alongside radiotherapy
  • Received a total radiotherapy dose between 54 and 66 Gy
  • Able to carry out normal activities (WHO performance status 0 or 1)
  • Healthy enough organs and bone marrow

Who may not be able to

  • Another cancer in the past 3 years (with some exceptions)
  • A mix of small cell and non-small cell lung cancer
  • Having chemotherapy and radiotherapy one after the other rather than together
  • Cancer that got worse during chemoradiotherapy
  • Ongoing side effects from chemoradiotherapy that are grade 2 or above (except hair loss)
  • Lung inflammation (pneumonitis) of grade 2 or above from earlier treatment
  • History of lung scarring or inflammation conditions, or active lung problems such as pneumonia or fluid on the lung
  • Active or past autoimmune or inflammatory conditions (with some exceptions)
  • Active Epstein-Barr virus (EBV) infection
  • Use of medicines that damp down the immune system within 14 days before starting durvalumab

What taking part involves

  • • Taking durvalumab together with domvanalimab after finishing chemoradiotherapy

Time commitment: Not stated — ask the trial team

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
791
Started
2022-02-18
Last checked
2026-08

Plain English Summary

What is this study?

  • • Testing a new treatment for non-small cell lung cancer
  • • Phase3 - 791 participants
  • • 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 take part?

  • • Ages 18 Years and over
  • • Diagnosed with non-small cell lung cancer

Where?

  • • Birmingham - Research Site
  • • Brighton - Research Site
  • • Cardiff - Research Site
  • • Cheltenham - Research Site
  • • +6 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Non-Small Cell Lung Cancer

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

PD-L1PD-L1 status ≥ 1%EGFRALKALK wild-type

Treatment history

Treatments you must have had:

  • ✓ received at least 2 cycles of platinum-based chemotherapy concurrent with radiation therapy

What the study is looking for

  • ✓Participant must be ≥ 18 years at the time of screening.
  • ✓Histologically- or cytologically-documented NSCLC and have been treated with concurrent CRT for that has grown locally,...
  • ✓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).

Who cannot take part

  • ✗History of another primary cancer, except for:
  • ✗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 that has grown locally (Stage...
See the full 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: 1. 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. 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.

Where Is This Study? (10 UK sites)

Research Site

Birmingham B9 5SS, United Kingdom

Research Site

Brighton BN2 5BE, United Kingdom

Research Site

Cardiff CF14 2TL, United Kingdom

Research Site

Cheltenham GL53 7AN, United Kingdom

Research Site

Edinburgh EH4 2XR, United Kingdom

Research Site

High Heaton/Newcastle Upon Tyn NE7 7DN, United Kingdom

Research Site

Leeds LS 9 7TF, United Kingdom

Research Site

London SE1 9RT, United Kingdom

Research Site

Nottingham NG5 1PB, United Kingdom

Research Site

Truro TR1 3LJ, United Kingdom

Data sourced from ClinicalTrials.gov · Last verified: 2026-08