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Assessing the effects of durvalumab and domvanalimab in advanced lung cancer after chemoradiation

A Phase III, Randomised, Double-blind, Placebo-controlled, Multicentre, International Study of Durvalumab Plus Domvanalimab(AB154) in Participants With Locally Advanced (Stage III), Unresectable Non-small Cell Lung Cancer Whose Disease Has Not Progressed Following Definitive Platinum-based Concurrent Chemoradiation Therapy

Phase 3 Interventional AstraZeneca · NCT05211895

This study is testing if a new combination of two drugs, durvalumab and domvanalimab, can help adults with advanced lung cancer feel better after they have received chemoradiation treatment.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment860 (estimated)
Ages18 Years and up
SexAll
SponsorAstraZeneca Industry-sponsored
Drugs / interventionsdurvalumab, chemotherapy, radiation, domvanalimab
Locations264 sites (Chandler, Arizona and 263 other locations)
Trial IDNCT05211895 on ClinicalTrials.gov

What this trial studies

This Phase III clinical trial evaluates the safety and efficacy of durvalumab combined with domvanalimab compared to durvalumab with a placebo in adults diagnosed with Stage III unresectable non-small cell lung cancer (NSCLC) who have not experienced disease progression after receiving concurrent chemoradiation therapy. The study is randomized, double-blind, and multicenter, involving multiple international sites. Participants must have specific tumor characteristics and performance status to qualify for the trial.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with Stage III unresectable NSCLC who have not progressed after concurrent chemoradiation.

Not a fit: Patients with progressed disease after chemoradiation or those with certain genetic mutations may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment combination could improve outcomes for patients with advanced lung cancer who have limited treatment options.

How similar studies have performed: Other studies have shown promising results with similar immunotherapy approaches in lung cancer, indicating potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion 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 this trial is running

Chandler, Arizona and 263 other locations

+214 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Non-Small Cell Lung Cancernon-small cell lung cancerlocally advancedNSCLC
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.