A Study of Durvalumab as Consolidation Therapy in Non-Small Cell Lung Cancer Patients
PACIFIC-5
A Phase III, Randomised,Double-Blind,Placebo-Controlled,Study of Durvalumab as Consolidation Therapy in Patients With Locally Advanced,Unresectable NSCLC, Who Have Not Progressed Following Definitive, Platinum-Based Chemoradiation Therapy
2 other identifiers
interventional
407
10 countries
87
Brief Summary
This is a Phase III, randomised, double-blind, placebo-controlled, multicentre study assessing the efficacy and safety of durvalumab compared with placebo, as consolidation therapy in patients with locally advanced, unresectable, non-small cell lung cancer (Stage III), who have not progressed following definitive, platinum-based, chemoradiation therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2018
Longer than P75 for phase_3
87 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 23, 2018
CompletedFirst Posted
Study publicly available on registry
October 16, 2018
CompletedStudy Start
First participant enrolled
November 27, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 23, 2024
CompletedResults Posted
Study results publicly available
February 12, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 26, 2027
ExpectedMay 13, 2026
May 1, 2026
5.6 years
August 23, 2018
January 17, 2025
May 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-Free Survival (PFS) (Modified Intent-to-Treat [mITT] Set)
The PFS per Response Evaluation Criteria in Solid Tumors 1.1. (RECIST 1.1) using blinded independent central review (BICR) assessments was defined as the time from the date of randomization until the date of objective disease progression (PD) or death (by any cause in the absence of progression) regardless of whether the participant withdrew from therapy or received another anti-cancer therapy prior to progression. The PD was defined as at least a 20% increase in the sum of diameters of target lesions (TLs) and an absolute increase of \>=5 millimeters (mm), taking as reference the smallest sum of diameters since treatment started including the baseline sum of diameters. Median PFS was calculated using the Kaplan-Meier technique.
Tumor scans performed at screening, every 8 weeks ±1 week up to 48 weeks, and then every 12 weeks ±1 week thereafter until confirmed PD. Assessed up to the DCO date 23-Jun-2024 (a maximum of approximately 2035 days)
Secondary Outcomes (12)
Overall Survival (OS)
Assessed up to the DCO date 23-Jun-2024 (a maximum of approximately 2035 days)
Progression-Free Survival (PFS) (Intent-to-Treat [ITT] Set)
Tumor scans performed at screening, every 8 weeks ±1 week up to 48 weeks, and then every 12 weeks ±1 week thereafter until confirmed PD. Assessed up to the DCO date 23-Jun-2024 (a maximum of approximately 2035 days)
Percentage of Participants Alive at 24 Months (OS24)
Month 24
Objective Response Rate (ORR)
Tumor scans performed at screening, every 8 weeks ±1 week up to 48 weeks, and then every 12 weeks ±1 week thereafter until confirmed PD. Assessed up to the DCO date 23-Jun-2024 (a maximum of approximately 2035 days)
Duration of Response (DoR)
Tumor scans performed at screening, every 8 weeks ±1 week up to 48 weeks, and then every 12 weeks ±1 week thereafter until confirmed PD. Assessed up to the DCO date 23-Jun-2024 (a maximum of approximately 2035 days)
- +7 more secondary outcomes
Study Arms (2)
Durvalumab Therapy
EXPERIMENTALDurvalumab (PD-L1 monoclonal antibody)1500 mg every 4 weeks \[q4w\] intravenously \[iv\] until clinical progression/deterioration or confirmed radiological progression)
Placebo Therapy
PLACEBO COMPARATORPlacebo (matching placebo for infusion every 4 weeks iv until clinical progression/deterioration or confirmed radiological progression)
Interventions
Matching placebo for infusion every 4 weeks iv until clinical progression/deterioration or confirmed radiological progression
Durvalumab 1500 mg every 4 weeks \[q4w\] intravenously \[iv\] until clinical progression/ deterioration or confirmed radiological progression.
Eligibility Criteria
You may qualify if:
- Age≥18 years
- Documented NSCLC and present with locally advanced, unresectable (Stage III) disease;
- Receipt of concurrent or sequential chemoradiation therapy,
- No progression following definitive, platinum-based, concurrent or sequential chemoradiation therapy
- World Health Organization (WHO) PS of 0 or 1;
- No prior exposure to any anti CTLA-4, anti-PD-1, anti-PD-L1, or anti PD L2 antibodies, excluding therapeutic anticancer vaccines
- Adequate organ and marrow function required
- Life expectancy of at least 12 weeks
- Tumor PD-L1 status, with the Ventana SP263 PD-L1 IHC assay determined by a reference laboratory, must be known prior to randomization.
- Tumour sample requirements are as follows: Provision of a tumour tissue sample (newly acquired sample \<=3 months old is preferred, but an archived sample \<=6 months old is acceptable) in a quantity sufficient to allow for analysis.
You may not qualify if:
- History of allogeneic organ transplantation, or another primary malignancy, or active primary immunodeficiency.
- Active or prior documented autoimmune or inflammatory disorders
- Uncontrolled intercurrent illness that would limit compliance with study requirement, substantially increase risk of incurring AEs, or compromise the ability of the patient to give written informed consent
- Active infection including tuberculosis hepatitis B hepatitis C (HCV), or human immunodeficiency virus (positive human immunodeficiency virus \[HIV\] 1/2 antibodies).
- Mixed small cell and NSCLC histology, sarcomatoid variant
- Any unresolved toxicity National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥2 from the prior chemoradiation therapy.
- Receipt of live attenuated vaccine within 30 days prior to the first dose of IP.
- Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (87)
Research Site
Beijing, 100021, China
Research Site
Beijing, 100142, China
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Beijing, 100730, China
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Beijing, 100853, China
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Bengbu, 233004, China
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Changchun, 130000, China
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Changchun, 510000, China
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Changsha, 410013, China
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Chengdu, 610041, China
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Chengdu, 610042, China
Research Site
Chengdu, 610072, China
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Chongqing, 400037, China
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Fuzhou, 350011, China
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Guangzhou, 510280, China
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Hangzhou, 310003, China
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Hangzhou, 310006, China
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Hangzhou, 310022, China
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Harbin, 150081, China
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Linhai, 317000, China
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Nanjing, 210009, China
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Nanning, 530021, China
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Ningbo, 315010, China
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Qingdao, 266042, China
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Shanghai, 200030, China
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Shanghai, 200032, China
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Shanghai, 200433, China
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Shenyang, 110042, China
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Ürümqi, 830000, China
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Wenzhou, 325000, China
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Wuhan, 430030, China
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Yangzhou, 225001, China
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Zhengzhou, 450000, China
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Zhengzhou, 450008, China
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Hong Kong, 00000, Hong Kong
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Bangalore, 560068, India
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Bengaluru, 560076, India
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Karamsad, 388325, India
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Kolkata, 700160, India
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Nashik, 422005, India
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Vadodara, 390007, India
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Culiacán, 80230, Mexico
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Mexico City, 0 3100, Mexico
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Mexico City, 11810, Mexico
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México, 1400, Mexico
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Monterrey, 64000, Mexico
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San Luis Potosí City, 78250, Mexico
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Bacolod, 6100, Philippines
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Baguio City, 2600, Philippines
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Cagayan de Oro, 9000, Philippines
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Cebu, 6000, Philippines
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Davao City, 8000, Philippines
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Quezon City, 1100, Philippines
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Quezon City, 1104, Philippines
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San Juan City, 1502, Philippines
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Bialystok, 15-540, Poland
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Gdansk, 80-952, Poland
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Poznan, 60-569, Poland
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Tomaszów Mazowiecki, 97-200, Poland
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Warsaw, 02-781, Poland
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Kazan, Tatarstan, 420029, Russia
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Kirov, 610021, Russia
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Moscow, 115478, Russia
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Moscow, 121467, Russia
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Murmansk, 183047, Russia
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Novosibirsk, 630055, Russia
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Novosibirsk, 630099, Russia
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Obninsk, 249036, Russia
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Saint Petersburg, 197758, Russia
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Samara, 443031, Russia
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Saransk, 430005, Russia
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Volgograd, 400138, Russia
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Daegu, 41944, South Korea
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Gwangju, 61469, South Korea
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Seoul, 08308, South Korea
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Taichung, 40705, Taiwan
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Tainan, 70403, Taiwan
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Taipei, 10002, Taiwan
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Taipei, 11217, Taiwan
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Taipei, 114, Taiwan
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Taipei, 235, Taiwan
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Taoyuan, 333, Taiwan
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Adana, 01060, Turkey (Türkiye)
Research Site
Ankara, 06340, Turkey (Türkiye)
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Edirne, 22030, Turkey (Türkiye)
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Istanbul, 34030, Turkey (Türkiye)
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Konya, 42080, Turkey (Türkiye)
Research Site
Malatya, 44100, Turkey (Türkiye)
Related Publications (1)
Wu YL, Wu L, Bi N, Cil T, Ge H, Zhu Z, Wang CL, Zhang W, Lv D, Mingyan E, Sun J, Pan Y, Krzakowski M, Dikilitas M, Sendur MAN, Kim YC, Yang Y, Mao R, Zhang B, Wang L. PACIFIC-5: a phase III clinical trial of consolidation durvalumab in patients with unresectable stage III NSCLC and no progression after concurrent or sequential chemoradiotherapy. J Hematol Oncol. 2025 Dec 7;18(1):111. doi: 10.1186/s13045-025-01768-1.
PMID: 41354932DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Clinical Lead
- Organization
- AstraZeneca
Study Officials
- PRINCIPAL INVESTIGATOR
Yilong Wu, MD
Guangdong General Hospital, Guangdong Lung Cancer Institute
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Sponsor, excluding supply chain management personnel and unblinded monitors of site pharmacies, will remain blinded.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 23, 2018
First Posted
October 16, 2018
Study Start
November 27, 2018
Primary Completion
June 23, 2024
Study Completion (Estimated)
February 26, 2027
Last Updated
May 13, 2026
Results First Posted
February 12, 2025
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.