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Assessing the effects of durvalumab with oleclumab or monalizumab in patients with advanced lung cancer

A Phase III, Double-blind, Placebo-controlled, Randomised, Multicentre, International Study of Durvalumab Plus Oleclumab and Durvalumab Plus Monalizumab in Patients With Locally Advanced (Stage III), Unresectable Non-small Cell Lung Cancer (NSCLC) Who Have Not Progressed Following Definitive, Platinum-Based Concurrent Chemoradiation Therapy

Phase 3 Interventional AstraZeneca · NCT05221840

This study tests if combining the drug durvalumab with either oleclumab or monalizumab can help adults with advanced lung cancer feel better after their initial treatment.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment999 (estimated)
Ages18 Years and up
SexAll
SponsorAstraZeneca Industry-sponsored
Drugs / interventionsdurvalumab, chemotherapy, radiation, oleclumab, monalizumab
Locations241 sites (San Diego, California and 240 other locations)
Trial IDNCT05221840 on ClinicalTrials.gov

What this trial studies

This Phase III clinical trial evaluates the safety and efficacy of durvalumab in combination with either oleclumab or monalizumab in adults diagnosed with Stage III unresectable non-small cell lung cancer (NSCLC) who have not shown disease progression after receiving platinum-based concurrent chemoradiation therapy. Participants will be randomly assigned to receive one of the treatment combinations or a placebo. The study aims to determine the effectiveness of these combinations in improving patient outcomes compared to standard treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with Stage III unresectable NSCLC who have completed platinum-based concurrent chemoradiation without disease progression.

Not a fit: Patients with a history of disease progression after initial treatment or those with specific genetic mutations may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients with advanced non-small cell lung cancer.

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

Eligibility criteria

Show full inclusion / exclusion criteria 
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 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 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, adequately resected non-melanoma skin cancer and curatively treated in situ disease, or adequately treated carcinoma in situ or Ta tumours 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 - diagnosed in the past 6 months prior to randomization.
* Active or prior documented autoimmune or inflammatory disorders (with exceptions)
* Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab.

Where this trial is running

San Diego, California and 240 other locations

+191 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 CancerLocally Advanced NSCLC
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.