A Phase 3 interventional study of Durvalumab and Oleclumab in Non-Small Cell Lung Cancer, sponsored by AstraZeneca. Active, not recruiting at 202 sites in 20 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-18.
Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment
This is a Phase III, randomised, double-blind, multicentre, international study assessing the efficacy and safety of durvalumab (MEDI4736) in combination with oleclumab (MEDI9447) or durvalumab (MEDI4736) with monalizumab (IPH2201) in adults with locally advanced (Stage III), unresectable NSCLC, who have not progressed following platinum-based cCRT.
6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,630 are open to participants now.
This study's enrollment of 1,051 is above the median of 62 across 5,211 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
EXCLUSION CRITERIA:
Durvalumab on Day 1 of each 28-day cycle + Oleclumab on Days 1 and 15 of cycles 1 and 2, then on Day 1 of each subsequent 28-day cycle for up to 12 months
Drug: Durvalumab · Drug: Oleclumab
Durvalumab + Monalizumab on Day 1 of each 28-day cycle for up to 12 months. Placebo infusion will be administered on Day 15 of cycles 1 and 2 only
Drug: Durvalumab · Drug: Monalizumab · Other: Placebo
Durvalumab on Day 1 of each 28-day cycle + Placebo on Days 1 and 15 of cycles 1 and 2, then on Day 1 of each subsequent 28-day cycle for up to 12 months
Drug: Durvalumab · Other: Placebo
Durvalumab IV (intravenous infusion)
Oleclumab IV (intravenous infusion)
Monalizumab IV (intravenous infusion)
Placebo IV (intravenous infusion)
Progression Free Surival (PFS)
Progression Free Survival (PFS) as assessed by BICR, per RECIST 1.1.
Time frame: Up to 5 years after first patient randomized.
Overall Survival (OS)
Overall survival (OS)
Time frame: Up to 9 years after first patient randomized
Objective response rate (ORR)
Objective response rate (ORR) per RECIST 1.1 as assessed by BICR
Time frame: Up to 5 years after first patient randomized
Overall survival (OS) at 24 months
Overall survival (OS) at 24 months
Time frame: Up to 9 years after first patient randomized
Duration of response (DoR)
Duration of response (DoR) per RECIST 1.1 as assessed by BICR
Time frame: Up to 5 years after first patient randomized
Progression free survival (PFS) at 6, 12, 18, and 24 months
Progression free survival (PFS) at 6, 12, 18, and 24 months respectively, per RECIST 1.1 as assessed by BICR
Time frame: From date of randomization until 24 months
Time from randomization to second progression (PFS2)
Time from randomization to second progression (PFS2)
Time frame: Up to 5 years after first patient randomized
Time from randomization to first date of distant metastasis or death (TTDM)
Time from randomization to first date of distant metastasis or death (TTDM)
Time frame: Up to 5 years after first patient randomized
Time from randomization to start date of first subsequent therapy (TFST)
Time from randomization to start date of first subsequent therapy (TFST)
Time frame: Up to 9 years after first patient randomized
Progression free survival (PFS) as assessed by Investigator
Progression free survival (PFS) as assessed by Investigator
Time frame: Up to 5 years after first patient randomized
IHC analysis of PD-L1 TC expression
IHC analysis of PD-L1 TC expression relative to efficacy outcomes
Time frame: Up to 5 years after first patient randomized
Concentration of Durvalumab
To assess the Pharmacokinetics of Durvalumab when in combination with Monalizumab or Oleclumab - serum peak and trough concentrations
Time frame: From date of randomization until 3 months after date of last IP dose
Anti-drug antibodies (ADAs)
The immunogenicity of durvalumab, oleclumab, and monalizumab as assessed by presence of anti-drug antibodies (ADAs)
Time frame: From date of randomization until 3 months after date of last IP dose
Time to deterioration in pulmonary symptoms (TTFCD)
Time to deterioration in pulmonary symptoms (TTFCD)
Time frame: Up to 5 years after last patient randomized
Concentration of Oleclumab
To assess the Pharmacokinetics of Oleclumab when in combination with Durvulumab - serum peak and trough concentrations
Time frame: From date of randomization until 3 months after last dose of IP
Concentration of Monalizumab
To assess the Pharmacokinetics of Monalizumab when in combination with Durvalumab - serum peak and trough concentrations
Time frame: From date of randomization until 3 months after last dose of IP
Showing the first 100 of 202 sites across 20 countries.
Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Supporting information: Study protocol, Sap
This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung→
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