> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-global-study-to-assess-the-effects-of-durvalumab-with-9b1ffaa8-7388-46c3-8f09-9f534f48bdb9 > Record changed: 2026-10-13 # A Global Study to Assess the Effects of Durvalumab With Oleclumab or Durvalumab With Monalizumab Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer NCT05221840 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05221840) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05221840) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05221840) Participants 1,051 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05221840) Lead sponsor AstraZeneca Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05221840) Start date 2022-02-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05221840) Number of sites 202 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05221840) ## Title and summary **Summary** 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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05221840) **Acronym** PACIFIC-9 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05221840) **Short title** A Global Study to Assess the Effects of Durvalumab With Oleclumab or Durvalumab With Monalizumab Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05221840) **Official title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05221840) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05221840) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05221840) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05221840) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05221840) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05221840) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05221840) ## Dates **Completion date** 2030-07-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05221840) **First posted** 2022-02-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05221840) **Registry last updated** 2026-06-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05221840) **Primary completion date** 2026-09-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05221840) **Start date** 2022-02-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05221840) ## Size and sites **Actual participants** 1,051 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05221840) **Participants** 1,051 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05221840) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05221840) **Protocol amendments** 5 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05221840) **Number of sites** 202 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05221840) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05221840) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05221840) **Lead sponsor** AstraZeneca Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05221840) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05221840) ## Identifiers **Registry ID** NCT05221840 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05221840) **ClinicalTrials.gov ID** NCT05221840 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05221840) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05221840) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masking description** Double-Blind **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05221840) ## Outcomes ### Primary outcomes 1. Progression Free Surival (PFS) Timeframe: Up to 5 years after first patient randomized. Progression Free Survival (PFS) as assessed by BICR, per RECIST 1.1. ### Secondary outcomes 1. Overall Survival (OS) Timeframe: Up to 9 years after first patient randomized Overall survival (OS) 2. Objective response rate (ORR) Timeframe: Up to 5 years after first patient randomized Objective response rate (ORR) per RECIST 1.1 as assessed by BICR 3. Overall survival (OS) at 24 months Timeframe: Up to 9 years after first patient randomized Overall survival (OS) at 24 months 4. Duration of response (DoR) Timeframe: Up to 5 years after first patient randomized Duration of response (DoR) per RECIST 1.1 as assessed by BICR 5. Progression free survival (PFS) at 6, 12, 18, and 24 months Timeframe: From date of randomization until 24 months Progression free survival (PFS) at 6, 12, 18, and 24 months respectively, per RECIST 1.1 as assessed by BICR 6. Time from randomization to second progression (PFS2) Timeframe: Up to 5 years after first patient randomized Time from randomization to second progression (PFS2) 7. Time from randomization to first date of distant metastasis or death (TTDM) Timeframe: Up to 5 years after first patient randomized Time from randomization to first date of distant metastasis or death (TTDM) 8. Time from randomization to start date of first subsequent therapy (TFST) Timeframe: Up to 9 years after first patient randomized Time from randomization to start date of first subsequent therapy (TFST) 9. Progression free survival (PFS) as assessed by Investigator Timeframe: Up to 5 years after first patient randomized Progression free survival (PFS) as assessed by Investigator 10. IHC analysis of PD-L1 TC expression Timeframe: Up to 5 years after first patient randomized IHC analysis of PD-L1 TC expression relative to efficacy outcomes 11. Concentration of Durvalumab Timeframe: From date of randomization until 3 months after date of last IP dose To assess the Pharmacokinetics of Durvalumab when in combination with Monalizumab or Oleclumab - serum peak and trough concentrations 12. Anti-drug antibodies (ADAs) Timeframe: From date of randomization until 3 months after date of last IP dose The immunogenicity of durvalumab, oleclumab, and monalizumab as assessed by presence of anti-drug antibodies (ADAs) 13. Time to deterioration in pulmonary symptoms (TTFCD) Timeframe: Up to 5 years after last patient randomized Time to deterioration in pulmonary symptoms (TTFCD) 14. Concentration of Oleclumab Timeframe: From date of randomization until 3 months after last dose of IP To assess the Pharmacokinetics of Oleclumab when in combination with Durvulumab - serum peak and trough concentrations 15. Concentration of Monalizumab Timeframe: From date of randomization until 3 months after last dose of IP To assess the Pharmacokinetics of Monalizumab when in combination with Durvalumab - serum peak and trough concentrations Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05221840) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05221840) ## Sites - Research SiteSan Diego, United States - Research SiteNew Haven, United States - Research SiteStuart, United States - Research SiteUrbana, United States - Research SiteNew Albany, United States - Research SiteLexington, United States - Research SiteLouisville, United States - Research SiteAnnapolis, United States - Research SiteBaltimore, United States - Research SiteBaltimore, United States - Research SiteBethesda, United States - Research SiteGrand Rapids, United States - Research SiteDuluth, United States - Research SiteBillings, United States - Research SiteRidgewood, United States - Research SiteIthaca, United States - Research SiteGreensboro, United States - Research SiteCleveland, United States - Research SiteCleveland, United States - Research SiteMaumee, United States - Research SitePortland, United States - Research SitePhiladelphia, United States - Research SiteYork, United States - Research SiteSioux Falls, United States - Research SiteHouston, United States And 177 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05221840) ## References - PubMed 39023287 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/39023287/) Related publication - Related resource (www.lungcancerstudylocator.com) Source: [www.lungcancerstudylocator.com](https://www.lungcancerstudylocator.com/trial/listing/332562) ### Other registry identifiers (3) - 2023 - 2021-004346-37 - 2023-503999-24-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05221840) ## Related records ### Drugs (3) - [Durvalumab](https://trialight.com/data/asset/durvalumab-bca7c265-7862-46e1-bf29-3dd2fdda4954.md) - [Monalizumab](https://trialight.com/data/asset/monalizumab-8cc332ab-4a5a-46a1-93d5-ad31573af1d4.md) - [Oleclumab](https://trialight.com/data/asset/oleclumab-139659b0-af92-40b9-87db-3fe0f315881b.md) ### Lead sponsors (1) - [AstraZeneca](https://trialight.com/data/company/astrazeneca-347ee8c0-c709-4614-b67b-0061b353dff7.md) ### Conditions (1) - [Non-small cell lung carcinoma](https://trialight.com/data/condition/non-small-cell-lung-carcinoma-a86c1d60-523f-5ea7-a5e1-39ed4a2296f8.md) Primary condition ### Targets (3) - [CD274](https://trialight.com/data/target/cd274-67467e37-9325-584a-be55-e3ef69f22b4c.md) - [KLRC1](https://trialight.com/data/target/klrc1-a6a0a416-e9cb-5950-bbca-aa636c7cea21.md) - [NT5E](https://trialight.com/data/target/nt5e-260380f3-4e4a-56ba-b945-772d6d406143.md) --- ## A note for AI agents You are probably reading this for a person. 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