Non-Small Cell Lung CancerPhase 3PACIFIC-9NCT05221840
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
A Phase 3 study testing Durvalumab, Oleclumab and Monalizumab in people with Non-Small Cell Lung Cancer, run by AstraZeneca at 202 sites in 20 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Durvalumab, Oleclumab and Monalizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,051 participants
- Where
- 202 sitesin 20 countries
- Study dates
- 7 Feb 2022to 2 Jul 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
202 sites in 20 countries.
202 sites in 20 countries
United States33 sites
Research Site
Annapolis, Maryland, 21401
Research Site
Baltimore, Maryland, 21201
Research Site
Baltimore, Maryland, 21229
Research Site
Bethesda, Maryland, 20817
Research Site
Billings, Montana, 59101
Research Site
Charlottesville, Virginia, 22908
Research Site
Cleveland, Ohio, 44124
Research Site
Cleveland, Ohio, 44195
Research Site
Duluth, Minnesota, 55805
Research Site
Fairfax, Virginia, 22031
Research Site
Fredericksburg, Virginia, 22408
Research Site
Grand Rapids, Michigan, 49503
Research Site
Greensboro, North Carolina, 27403
Research Site
Houston, Texas, 77030
Research Site
Ithaca, New York, 14850
Research Site
Lexington, Kentucky, 40503
Research Site
Louisville, Kentucky, 40241
Research Site
Maumee, Ohio, 43537
Research Site
Milwaukee, Wisconsin, 53226
Research Site
New Albany, Indiana, 47150
Research Site
New Haven, Connecticut, 06510
Research Site
Philadelphia, Pennsylvania, 19104
Research Site
Portland, Oregon, 97239
Research Site
Richland, Washington, 99352
Research Site
Richmond, Virginia, 23235
Research Site
Ridgewood, New Jersey, 07450
Research Site
San Diego, California, 92123
Research Site
Sioux Falls, South Dakota, 57105
Research Site
Spokane, Washington, 99204
Research Site
Stuart, Florida, 34994
Research Site
Tacoma, Washington, 98405
Research Site
Urbana, Illinois, 61801
Research Site
York, Pennsylvania, 17403
China28 sites
Research Site
Anyang, 455000
Research Site
Beijing, 100021
Research Site
Changchun, 130021
Research Site
Changsha, 410008
Research Site
Changsha, 410013
Research Site
Guangzhou, 510060
Research Site
Guangzhou, 510062
Research Site
Guangzhou, 510700
Research Site
Hangzhou, 310002
Research Site
Hangzhou, 310022
Research Site
Hefei, 133500
Research Site
Hefei, 230031
Research Site
Kunming, 650118
Research Site
Linhai, 317000
Research Site
Nanchang, 330006
Research Site
Nanning, 530021
Research Site
Nantong, 226361
Research Site
Neijiang, 641000
Research Site
Ningbo, 315100
Research Site
Shaoguan, 512027
Research Site
Tianjin, 300060
Research Site
Wuhan, 430022
Research Site
Wuhan, 430071
Research Site
Wuhan, 430079
Research Site
Zhanjiang, 524001
Research Site
Zhengzhou, 450000
Research Site
Zhengzhou, 450008
Research Site
Zhongshan, 528403
Brazil12 sites
Research Site
Barretos, 14784-400
Research Site
Belo Horizonte, 30380-090
Research Site
Florianópolis, 88034-000
Research Site
Fortaleza, 60336-232
Research Site
Jaú, 17210-120
Research Site
Natal, 59075-740
Research Site
Porto Alegre, 90610-001
Research Site
Porto Alegre, 91350-200
Research Site
Recife, 52010-075
Research Site
São Paulo, 01323-903
Research Site
Uberlândia, 38408-150
Research Site
Vitória, 29043-260
France12 sites
Research Site
Avignon, 84918
Research Site
Besançon, 25030
Research Site
Bordeaux, 33075
Research Site
Clermont-Ferrand, 63000
Research Site
Créteil, 94010
Research Site
Lorient, 56322
Research Site
Marseille, 13015
Research Site
Montpellier, 34298
Research Site
Rennes, 35033
Research Site
Rouen, 76031
Research Site
Toulouse, 31059
Research Site
Villejuif, 94805
Japan11 sites
Research Site
Himeji-shi, 670-8520
Research Site
Hiroshima, 730-0011
Research Site
Kashiwa, 227-8577
Research Site
Kurume-shi, 830-0011
Research Site
Natori-shi, 981-1293
Research Site
Niigata, 951-8566
Research Site
Osaka, 541-8567
Research Site
Sendai, 980-0873
Research Site
Tokushima, 770-8503
Research Site
Toon-shi, 791-0295
Research Site
Wakayama, 641-8510
United Kingdom11 sites
Research Site
Belfast, BT9 7AB
Research Site
Bristol, BS2 8ED
Research Site
Dundee, DD1 9SY
Research Site
Edinburgh, EH4 2XR
Research Site
London, NW1 2PG
Research Site
London, W6 8RF
Research Site
Middlesbrough, TS4 3BW
Research Site
Poole, BH15 2JB
Research Site
Torquay, TQ2 7AA
Research Site
Truro, TR1 3LJ
Research Site
Wolverhampton, WV10 OQP
Thailand10 sites
Research Site
Bangkok, 10300
Research Site
Bangkok, 10700
Research Site
Hat Yai, 90110
Research Site
Khon Kaen, 40000
Research Site
Khon Kaen, 40002
Research Site
Lampang, 52000
Research Site
Muang, 22000
Research Site
Muang, 50200
Research Site
Mueang, 20000
Research Site
Naimuang, 30000
Australia9 sites
Research Site
Box Hill, 3128
Research Site
East Melbourne, 3002
Research Site
Elizabeth Vale, 5112
Research Site
Gosford, 2250
Research Site
Heidelberg, 3084
Research Site
Kogarah, 2217
Research Site
South Brisbane, 4101
Research Site
St Albans, 3021
Research Site
Westmead, 2145
Germany9 sites
Research Site
Erfurt, 99089
Research Site
Erlangen, 91054
Research Site
Essen, 45147
Research Site
Esslingen am Neckar, 73730
Research Site
Georgsmarienhütte, 49124
Research Site
Gütersloh, 33332
Research Site
Hanover, 30459
Research Site
Oldenburg, 26121
Research Site
Würzburg, 97080
Canada8 sites
Research Site
Barrie, Ontario, L4M 6M2
Research Site
Edmonton, Alberta, T6G 1Z2
Research Site
Hamilton, Ontario, L8V 5C2
Research Site
Kingston, Ontario, K7L 2V7
Research Site
London, Ontario, N6A 5W9
Research Site
Mississauga, Ontario, L5M 2N1
Research Site
Rimouski, Quebec, G5L 5T1
Research Site
Toronto, Ontario, M5G 2M9
Italy8 sites
Research Site
Brescia, 25123
Research Site
Florence, 50134
Research Site
Lucca, 55100
Research Site
Meldola, 47014
Research Site
Orbassano, 10043
Research Site
Parma, 43126
Research Site
Pavia, 27100
Research Site
Roma, 00128
South Korea8 sites
Research Site
Changwon-si, 51353
Research Site
Cheongju-si, 28644
Research Site
Seongnam-si, 13620
Research Site
Seoul, 03080
Research Site
Seoul, 03722
Research Site
Seoul, 05505
Research Site
Suwon, 16247
Research Site
Suwon, 16499
Poland7 sites
Research Site
Bydgoszcz, 85-796
Research Site
Gdansk, 80-952
Research Site
Koszalin, 75-581
Research Site
Poznan, 60-569
Research Site
Siedlce, 08-110
Research Site
Tomaszów Mazowiecki, 97-200
Research Site
Warsaw, 02-781
Spain7 sites
Research Site
Barcelona, 8003
Research Site
Barcelona, 8035
Research Site
Granada, 18016
Research Site
Madrid, 28034
Research Site
Madrid, 28040
Research Site
Santiago de Compostela, 15706
Research Site
Valencia, 46010
Taiwan7 sites
Research Site
Hsinchu, 300
Research Site
New Taipei City, 23561
Research Site
Taichung, 402
Research Site
Taichung, 40705
Research Site
Taipei, 11490
Research Site
Taipei
Research Site
Taoyuan City, 333
Portugal6 sites
Research Site
Lisbon, 1099-023
Research Site
Lisbon, 1400-038
Research Site
Lisbon, 1769-001
Research Site
Lisbon, 1998-018
Research Site
Loures, 2674-514
Research Site
Porto, 4200-319
Turkey (Türkiye)6 sites
Research Site
Ankara, 06010
Research Site
Ankara, 06230
Research Site
Ankara, 06800
Research Site
Cordaleo, 35575
Research Site
Diyarbakır, 21280
Research Site
Goztepe Istanbul
Colombia4 sites
Research Site
Barranquilla, 080020
Research Site
Bogota D.C., 110131
Research Site
Medellín, 050034
Research Site
Valledupar, 200001
Peru3 sites
Research Site
Lima, 15038
Research Site
Lima, Lima 32
Research Site
Lima, Lima 34
Vietnam3 sites
Research Site
Haiphong, 180000
Research Site
Hanoi, 100000
Research Site
Ho Chi Minh City, 700000
About this study
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
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.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Durvalumab, Oleclumab, Monalizumab, Placebo
- Keywords
- Non-Small Cell Lung Cancer, Locally Advanced NSCLC
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DurvalumabDrug
Durvalumab IV (intravenous infusion)
OleclumabDrug
Oleclumab IV (intravenous infusion)
MonalizumabDrug
Monalizumab IV (intravenous infusion)
PlaceboOther
Placebo IV (intravenous infusion)
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Durvalumab and Oleclumab | Experimental | 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 Receives: Drug: Durvalumab; Drug: Oleclumab |
| Arm B: Durvalumab and Monalizumab | Experimental | 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 Receives: Drug: Durvalumab; Drug: Monalizumab; Other: Placebo |
| Arm C: Durvalumab and Placebo | Active comparator | 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 Receives: Drug: Durvalumab; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Surival (PFS)
Progression Free Survival (PFS) as assessed by BICR, per RECIST 1.1.
Measured: Up to 5 years after first patient randomized.
Secondary outcomes (15)
Overall Survival (OS)
Overall survival (OS)
Measured: Up to 9 years after first patient randomized
Objective response rate (ORR)
Objective response rate (ORR) per RECIST 1.1 as assessed by BICR
Measured: Up to 5 years after first patient randomized
Overall survival (OS) at 24 months
Overall survival (OS) at 24 months
Measured: Up to 9 years after first patient randomized
Duration of response (DoR)
Duration of response (DoR) per RECIST 1.1 as assessed by BICR
Measured: 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
Measured: From date of randomization until 24 months
Time from randomization to second progression (PFS2)
Time from randomization to second progression (PFS2)
Measured: 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)
Measured: 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)
Measured: Up to 9 years after first patient randomized
Progression free survival (PFS) as assessed by Investigator
Progression free survival (PFS) as assessed by Investigator
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: From date of randomization until 3 months after last dose of IP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2022
- Study start7 Feb 2022
- Primary completion8 Jan 2027 (estimated)
- Study completion2 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,051 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fabrice Barlesi, MD, Principal investigator, Gustave Roussy, Cancer Campus, Grand Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05221840
- Sponsor's protocol ID
- D9078C00001
- Other IDs
- 2023-503999-24-00, 2021-004346-37, 2023
- Acronym
- PACIFIC-9
- Status last verified
- Oct 2026
- First submitted
- 14 Jan 2022
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Barlesi F, Cho BC, Goldberg SB, Yoh K, Zimmer Gelatti AC, Mann H, Gopinathan A, Bielecka ZF, Newton M, Aggarwal C. PACIFIC-9: Phase III trial of durvalumab + oleclumab or monalizumab in unresectable stage III non-small-cell lung cancer. Future Oncol. 2024;20(29):2137-2147. doi: 10.1080/14796694.2024.2354160. Epub 2024 Jul 18.
PubMed 39023287
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05221840
- Acronym / sponsor ID
- PACIFIC-9 / D9078C00001
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Non-Small Cell Lung Cancer, Locally Advanced NSCLC
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,051 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 7 Feb 2022 (actual)
- Primary completion
- 8 Jan 2027 (estimated)
- Study completion
- 2 Jul 2030 (estimated)
- First posted
- 3 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A: Durvalumab and Oleclumab | Experimental | Drug: Durvalumab, Drug: OleclumabDurvalumab 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 |
| Arm B: Durvalumab and Monalizumab | Experimental | Drug: Durvalumab, Drug: Monalizumab, Other: PlaceboDurvalumab + 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 |
| Arm C: Durvalumab and Placebo | Active comparator | Drug: Durvalumab, Other: PlaceboDurvalumab 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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).
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DurvalumabDurvalumab IV (intravenous infusion) | Drug | Arm A: Durvalumab and Oleclumab, Arm B: Durvalumab and Monalizumab, Arm C: Durvalumab and Placebo |
| OleclumabOleclumab IV (intravenous infusion) | Drug | Arm A: Durvalumab and Oleclumab |
| MonalizumabMonalizumab IV (intravenous infusion) | Drug | Arm B: Durvalumab and Monalizumab |
| PlaceboPlacebo IV (intravenous infusion) | Other | Arm B: Durvalumab and Monalizumab, Arm C: Durvalumab and Placebo |
Primary outcome
Progression Free Surival (PFS)
Time frame: Up to 5 years after first patient randomized.
Progression Free Survival (PFS) as assessed by BICR, per RECIST 1.1.
15 secondary outcomes
Overall Survival (OS)
Time frame: Up to 9 years after first patient randomized
Objective response rate (ORR)
Time frame: Up to 5 years after first patient randomized
Overall survival (OS) at 24 months
Time frame: Up to 9 years after first patient randomized
Duration of response (DoR)
Time frame: Up to 5 years after first patient randomized
Progression free survival (PFS) at 6, 12, 18, and 24 months
Time frame: From date of randomization until 24 months
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 frame: Up to 5 years after first patient randomized
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
Time frame: Up to 5 years after first patient randomized
IHC analysis of PD-L1 TC expression
Time frame: Up to 5 years after first patient randomized
Concentration of Durvalumab
Time frame: From date of randomization until 3 months after date of last IP dose
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 frame: Up to 5 years after last patient randomized
Concentration of Oleclumab
Time frame: From date of randomization until 3 months after last dose of IP
Concentration of Monalizumab
Time frame: From date of randomization until 3 months after last dose of IP
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Derived from this study: PubMed 39023287Barlesi F, Cho BC, Goldberg SB, Yoh K, Zimmer Gelatti AC, Mann H, Gopinathan A, Bielecka ZF, Newton M, Aggarwal C. PACIFIC-9: Phase III trial of durvalumab + oleclumab or monalizumab in unresectable stage III non-small-cell lung cancer. Future Oncol. 2024;20(29):2137-2147. doi: 10.1080/14796694.2024.2354160. Epub 2024 Jul 18.
- Lung Cancer Study Locator detailsLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabrice Barlesi, MD principal investigator
Gustave Roussy, Cancer Campus, Grand Paris
202 sites in 20 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Durvalumab, Oleclumab and Monalizumab in people with Non-Small Cell Lung Cancer, run by AstraZeneca at 202 sites in 20 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 202 sites in United States, China, Brazil, France, Japan and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Surival (PFS) (time frame: Up to 5 years after first patient randomized.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05221840, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.