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Study of Durvalumab and Domvanalimab for Stage III Lung Cancer

This study is for adults with Stage III non-small cell lung cancer (NSCLC) that cannot be removed by surgery and has not worsened after initial chemotherapy and radiation. It is testing two medications, durvalumab and domvanalimab, given intravenously (IV), against durvalumab plus a placebo (an inactive substance). The goal is to see if this combination is safe and effective in preventing the cancer from growing or spreading. To join, you must be at least 18 years old, have Stage III NSCLC, and have a tumor sample showing at least 1% PD-L1 (a protein on cancer cells). The main measure of success is how long participants live without their cancer progressing, which will be tracked for up to 8 years.

Study design
This is a Phase III, randomized, double-blind study involving 860 participants. Participants will receive either durvalumab and domvanalimab, or durvalumab and a placebo.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 8 years after being randomly assigned to a treatment group to assess how long they live without their cancer progressing.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05211895

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

Active, Not Recruiting
PHASE3Ages 18+InterventionalTreatment
AstraZeneca
~791 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:DurvalumabDomvanalimabPlacebo

At a glance

Recruiting sites
0 of 226 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression Free Survival (PFS)
Measured over Up to 5 years after randomization

Conditions

Non-Small Cell Lung Cancer

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Where it's being run

226 sites across 50 states
Japan20
Germany16
India15
France11
South Korea10
Turkey (Türkiye)10
United Kingdom10
Taiwan9

Study leadership

  • Hidehito Horinouchi, MD, PhD · PRINCIPAL_INVESTIGATOR · National Cancer Center Hospital
  • Alexander Spira, MD, PhD · PRINCIPAL_INVESTIGATOR · Virginia Cancer Specialists Research Institute
  • Jinming Yu, MD, PhD · PRINCIPAL_INVESTIGATOR · Shandong Cancer Hospital and Institute

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

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.

What this trial measures

  • Progression Free Survival (PFS)Up to 5 years after randomization

    Defined as time from randomisation until progression per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR), or death due to any cause in participants with PD-L1 TC ≥ 50%. Outcomes measures were applicable with the previous version of the protocol. The study objectives are considered descriptive rather than confirmatory according to the protocol amendment.