- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03706690
A Study of Durvalumab as Consolidation Therapy in Non-Small Cell Lung Cancer Patients (PACIFIC-5)
February 26, 2024 updated by: AstraZeneca
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
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
Approximately 400 patients will be randomized in a 2:1 to receive treatment with durvalumab or placebo therapy.
The primary objective of this study is to assess the efficacy of durvalumab treatment compared with placebo in terms of PFS.
Study Type
Interventional
Enrollment (Actual)
407
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Beijing, China, 100142
- Research Site
-
Beijing, China, 100021
- Research Site
-
Beijing, China, 100730
- Research Site
-
Beijing, China, 100853
- Research Site
-
Bengbu, China, 233060
- Research Site
-
Changchun, China, 130000
- Research Site
-
Changsha, China, 410013
- Research Site
-
Chengdu, China, 610041
- Research Site
-
Chengdu, China, 610042
- Research Site
-
Chengdu, China, 610072
- Research Site
-
Chongqing, China, CN-400037
- Research Site
-
Fuzhou, China, 350011
- Research Site
-
Guangzhou, China, 510100
- Research Site
-
Guangzhou, China, 510280
- Research Site
-
Hangzhou, China, 310006
- Research Site
-
Hangzhou, China, 310022
- Research Site
-
Hangzhou, China, 310003
- Research Site
-
Harbin, China, 150081
- Research Site
-
Linhai, China, 317000
- Research Site
-
Nanjing, China, 210009
- Research Site
-
Nanning, China, 530021
- Research Site
-
Ningbo, China, 315010
- Research Site
-
Qingdao, China, 266042
- Research Site
-
Shanghai, China, 200032
- Research Site
-
Shanghai, China, 200433
- Research Site
-
Shanghai, China, 200030
- Research Site
-
Shenyang, China, 110042
- Research Site
-
Wenzhou, China, 325000
- Research Site
-
Wuhan, China, 430030
- Research Site
-
Yangzhou, China, 225001
- Research Site
-
Zhengzhou, China, 450008
- Research Site
-
Zhengzhou, China, 450000
- Research Site
-
Ürümqi, China, 830000
- Research Site
-
-
-
-
-
Hong Kong, Hong Kong, 00000
- Research Site
-
HongKong, Hong Kong, 00000
- Research Site
-
-
-
-
-
Bangalore, India, 560068
- Research Site
-
Bengaluru, India, 560076
- Research Site
-
Karamsad, India, 388325
- Research Site
-
Kolkata, India, 700160
- Research Site
-
Nasik, India, 422005
- Research Site
-
Vadodara, India, 390007
- Research Site
-
-
-
-
-
Daegu, Korea, Republic of, 41944
- Research Site
-
Gwangju, Korea, Republic of, 61469
- Research Site
-
Seoul, Korea, Republic of, 08308
- Research Site
-
-
-
-
-
Cdmx, Mexico, 11810
- Research Site
-
Culiacán, Mexico, 80230
- Research Site
-
Mexico City, Mexico, 0 3100
- Research Site
-
Monterrey, Mexico, 64000
- Research Site
-
México, Mexico, 1400
- Research Site
-
San Luis Potosí, Mexico, 78250
- Research Site
-
-
-
-
-
Bacolod, Philippines, 6100
- Research Site
-
Baguio City, Philippines, 2600
- Research Site
-
Cagayan De Oro City, Philippines, 9000
- Research Site
-
Cebu, Philippines, 6000
- Research Site
-
Davao City, Philippines, 8000
- Research Site
-
Quezon City, Philippines, 1104
- Research Site
-
Quezon City, Philippines, 1100
- Research Site
-
San Juan, Philippines, 1502
- Research Site
-
-
-
-
-
Białystok, Poland, 15-540
- Research Site
-
Gdańsk, Poland, 80-214
- Research Site
-
Poznań, Poland, 60-569
- Research Site
-
Tomaszów Mazowiecki, Poland, 97-200
- Research Site
-
Warszawa, Poland, 02-781
- Research Site
-
-
-
-
-
Kazan, Tatarstan, Russian Federation, 420029
- Research Site
-
Kirov, Russian Federation, 610021
- Research Site
-
Moscow, Russian Federation, 115478
- Research Site
-
Moscow, Russian Federation, 121467
- Research Site
-
Murmansk, Russian Federation, 183047
- Research Site
-
Novosibirsk, Russian Federation, 630055
- Research Site
-
Novosibirsk, Russian Federation, 630099
- Research Site
-
Obninsk, Russian Federation, 249036
- Research Site
-
Saint Petersburg, Russian Federation, 197758
- Research Site
-
Samara, Russian Federation, 443031
- Research Site
-
Saransk, Russian Federation, 430005
- Research Site
-
Volgograd, Russian Federation, 400138
- Research Site
-
-
-
-
-
Taichung, Taiwan, 40705
- Research Site
-
Tainan, Taiwan, 70403
- Research Site
-
Taipei, Taiwan, 235
- Research Site
-
Taipei, Taiwan, 10002
- Research Site
-
Taipei, Taiwan, 11217
- Research Site
-
Taipei City, Taiwan, 114
- Research Site
-
Taoyuan, Taiwan, 333
- Research Site
-
-
-
-
-
Adana, Turkey, 01060
- Research Site
-
Ankara, Turkey, 06340
- Research Site
-
Edirne, Turkey, 22030
- Research Site
-
Istanbul, Turkey, 34030
- Research Site
-
Konya, Turkey, 42080
- Research Site
-
Malatya, Turkey, 44100
- Research Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 130 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Durvalumab Therapy
Durvalumab (PD-L1 monoclonal antibody)1500 mg every 4 weeks [q4w] intravenously [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.
Other Names:
|
Placebo Comparator: Placebo Therapy
Placebo (matching placebo for infusion every 4 weeks iv until clinical progression/deterioration or confirmed radiological progression)
|
Matching placebo for infusion every 4 weeks iv until clinical progression/deterioration or confirmed radiological progression
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-Free Survival (PFS) according to RECIST 1.1.
Time Frame: from date of randomisation until disease progression, assessed up to 29 months.
|
To assess the efficacy of durvalumab treatment compared with placebo in terms of PFS.
|
from date of randomisation until disease progression, assessed up to 29 months.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The efficacy of durvalumab treatment compared to placebo in terms of Overall Survival (OS).
Time Frame: from date of randomisation until the date of death, assessed up to 65 months.
|
To further assess the efficacy of durvalumab compared with placebo in terms of OS.
|
from date of randomisation until the date of death, assessed up to 65 months.
|
The efficacy of durvalumab treatment compared to placebo in terms of proportion of patients alive at 24 months (OS24) from randomisation.
Time Frame: at 24 months from participants' randomisation.
|
To further assess the efficacy of durvalumab compared with placebo in terms of OS24.
|
at 24 months from participants' randomisation.
|
Objective Response Rate (ORR) assessed by BICR according to RECIST 1.1.
Time Frame: from date of randomisation until progression, or the last evaluable assessment in the absence of progression, assessed up to 29 months.
|
To further assess the efficacy of durvalumab compared with placebo in terms of ORR.
|
from date of randomisation until progression, or the last evaluable assessment in the absence of progression, assessed up to 29 months.
|
Duration of Response (DoR) assessed by BICR according to RECIST 1.1.
Time Frame: from date of randomisation until progression, or the last evaluable assessment in the absence of progression, assessed up to 29 months.
|
To further assess the efficacy of durvalumab compared with placebo in terms of DOR.
|
from date of randomisation until progression, or the last evaluable assessment in the absence of progression, assessed up to 29 months.
|
Proportion of patients alive and progression free from randomisation to second progression (PFS2) as defined by local standard clinical practice.
Time Frame: from randomisation to second progression. assessed up to 65 months.
|
The date of PFS2 assessment and Investigator opinion of progression status (progressed or non-progressed) at each assessment will be recorded in the PFS2 eCRF.
|
from randomisation to second progression. assessed up to 65 months.
|
Proportion of patients alive and progression free at 12 months from randomisation (PFS12) assessed by BICR according to RECIST 1.1.
Time Frame: at 12 months from participants' randomisation.
|
To further assess the efficacy of durvalumab compared with placebo in terms of PFS12.
|
at 12 months from participants' randomisation.
|
Proportion of patients alive and progression free at 18 months from randomisation (PFS18) assessed by BICR according to RECIST 1.1.
Time Frame: at 18 months from participants' randomisation.
|
To further assess the efficacy of durvalumab compared with placebo in terms of PFS18.
|
at 18 months from participants' randomisation.
|
Proportion of patients at time to death or distant metastasis (TTDM) assessed by BICR according to RECIST 1.1.
Time Frame: date of randomisation until the first date of distant metastasis or death in the absence of distant metastasis, assessed up to 65 months.
|
To further assess the efficacy of durvalumab compared with placebo in terms of TTDM.
|
date of randomisation until the first date of distant metastasis or death in the absence of distant metastasis, assessed up to 65 months.
|
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time Frame: from randomisation until 3 months after treatment discontinuation.
|
All AE data will be listed and the treatment-emergence status will be flagged in the listing.
|
from randomisation until 3 months after treatment discontinuation.
|
Detection of ADA neutralising antibodies titres for all randomised patients
Time Frame: at scheduled visits from randomisation to 6months after treatment discontinuation.
|
To investigate the immunogenicity of durvalumab
|
at scheduled visits from randomisation to 6months after treatment discontinuation.
|
IHC analysis of tumoural PD-L1 expression and spatial distribution within the tumour microenvironment relative to efficacy outcome OS.
Time Frame: from date of randomisation until the date of death from any cause, whichever came first, assessed up to 65 months.
|
To investigate the relationship between a patient's baseline tumour PD-L1 expression and OS with durvalumab compared with placebo.
|
from date of randomisation until the date of death from any cause, whichever came first, assessed up to 65 months.
|
IHC analysis of tumoural PD-L1 expression and spatial distribution within the tumour microenvironment relative to efficacy outcome PFS.
Time Frame: from date of randomisation until disease progression, assessed up to 29 months.
|
To investigate the relationship between a patient's baseline tumour PD-L1 expression and PFS with durvalumab compared with placebo.
|
from date of randomisation until disease progression, assessed up to 29 months.
|
IHC analysis of tumoural PD-L1 expression and spatial distribution within the tumour microenvironment relative to efficacy outcome ORR.
Time Frame: from date of randomisation until progression, or the last evaluable assessment in the absence of progression, assessed up to 29 months.
|
To investigate the relationship between a patient's baseline tumour PD-L1 expression and ORR with durvalumab compared with placebo.
|
from date of randomisation until progression, or the last evaluable assessment in the absence of progression, assessed up to 29 months.
|
Concentration of durvalumab in blood and non-compartmental PK parameters (such as peak concentration and trough, as data allow) (sparse sampling)
Time Frame: at scheduled visits from randomisation to 3months after treatment discontinuation.
|
To assess the PK of durvalumab
|
at scheduled visits from randomisation to 3months after treatment discontinuation.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Yilong Wu, MD, Guangdong General Hospital, Guangdong Lung Cancer Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 27, 2018
Primary Completion (Estimated)
June 21, 2024
Study Completion (Estimated)
March 16, 2027
Study Registration Dates
First Submitted
August 23, 2018
First Submitted That Met QC Criteria
October 11, 2018
First Posted (Actual)
October 16, 2018
Study Record Updates
Last Update Posted (Estimated)
February 28, 2024
Last Update Submitted That Met QC Criteria
February 26, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- D933YC00001
- 2018-002294-22 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
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.
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Carcinoma, Non-Small-Cell Lung
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Bristol-Myers SquibbCompletedStage IIIA Non-Small Cell Lung Cancer | Stage IIA Non-Small Cell Lung Carcinoma | Stage IIB Non-Small Cell Lung Carcinoma | Stage I Non-Small Cell Lung Cancer | Stage II Non-Small Cell Lung Cancer | Stage IA Non-Small Cell Lung Carcinoma | Stage IB Non-Small Cell Lung Carcinoma | Non-Squamous Non-Small...United States
-
National Cancer Institute (NCI)CompletedStage IIIA Non-Small Cell Lung Cancer | Recurrent Non-Small Cell Lung Carcinoma | Stage IV Non-Small Cell Lung Cancer | Stage IIA Non-Small Cell Lung Carcinoma | Stage IIB Non-Small Cell Lung Carcinoma | Stage IB Non-Small Cell Lung CarcinomaUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingStage IB Lung Non-Small Cell Carcinoma AJCC v7 | Stage IIA Lung Non-Small Cell Carcinoma AJCC v7 | Stage IIB Lung Non-Small Cell Carcinoma AJCC v7 | Stage IIIA Lung Non-Small Cell Cancer AJCC v7 | Recurrent Lung Non-Small Cell Carcinoma | Stage IIIB Lung Non-Small Cell Cancer AJCC v7 | Stage IA...United States
-
National Cancer Institute (NCI)TerminatedStage IIIA Non-Small Cell Lung Cancer | Stage IIA Non-Small Cell Lung Carcinoma | Stage IIB Non-Small Cell Lung Carcinoma | Stage IA Non-Small Cell Lung Carcinoma | Stage IB Non-Small Cell Lung CarcinomaUnited States
-
National Cancer Institute (NCI)TerminatedStage IIIA Non-Small Cell Lung Cancer | Stage IIA Non-Small Cell Lung Carcinoma | Stage IIB Non-Small Cell Lung Carcinoma | Stage IA Non-Small Cell Lung Carcinoma | Stage IB Non-Small Cell Lung CarcinomaUnited States
-
M.D. Anderson Cancer CenterActive, not recruitingStage IB Lung Non-Small Cell Carcinoma AJCC v7 | Stage II Lung Non-Small Cell Cancer AJCC v7 | Stage IIA Lung Non-Small Cell Carcinoma AJCC v7 | Stage IIB Lung Non-Small Cell Carcinoma AJCC v7 | Stage IIIA Lung Non-Small Cell Cancer AJCC v7 | Stage I Lung Non-Small Cell Cancer AJCC v7 | Stage...United States
-
National Cancer Institute (NCI)Active, not recruitingLung Non-Squamous Non-Small Cell Carcinoma | Stage IB Lung Non-Small Cell Carcinoma AJCC v7 | Stage II Lung Non-Small Cell Cancer AJCC v7 | Stage IIA Lung Non-Small Cell Carcinoma AJCC v7 | Stage IIB Lung Non-Small Cell Carcinoma AJCC v7 | Stage IIIA Lung Non-Small Cell Cancer AJCC v7United States, Puerto Rico
-
National Cancer Institute (NCI)Active, not recruitingStage IIIA Lung Non-Small Cell Cancer AJCC v7 | Advanced Lung Non-Squamous Non-Small Cell Carcinoma | Metastatic Lung Non-Squamous Non-Small Cell Carcinoma | Stage IIIB Lung Non-Small Cell Cancer AJCC v7 | Stage IV Lung Non-Small Cell Cancer AJCC v7 | Stage III Lung Non-Small Cell Cancer AJCC...United States
-
University of Southern CaliforniaNational Cancer Institute (NCI); Society of Thoracic RadiologyActive, not recruitingStage IIA Non-Small Cell Lung Carcinoma | Stage IIB Non-Small Cell Lung Carcinoma | Stage IA Non-Small Cell Lung Carcinoma | Stage IB Non-Small Cell Lung CarcinomaUnited States
-
National Cancer Institute (NCI)CompletedStage IIIA Non-Small Cell Lung Cancer | Stage IIIB Non-Small Cell Lung Cancer | Stage IIA Non-Small Cell Lung Carcinoma | Stage IIB Non-Small Cell Lung Carcinoma | Stage IA Non-Small Cell Lung Carcinoma | Stage IB Non-Small Cell Lung CarcinomaUnited States
Clinical Trials on Durvalumab
-
AstraZenecaKappa SantéRecruiting
-
Yonsei UniversityRecruitingPotentially Resectable Stage II/IIIa NSCLCKorea, Republic of
-
Academic Thoracic Oncology Medical Investigators...AstraZenecaCompletedNon-Small Cell Lung Cancer NSCLCUnited States
-
Yonsei UniversityCompleted
-
NSABP Foundation IncCompletedRectal CancerUnited States
-
Hark Kyun KimRecruiting
-
Oslo University HospitalAstraZenecaActive, not recruitingCancer | NSCLC | Non Small Cell Lung Cancer | NSCLC, Stage III | Non Small Cell Lung Cancer Stage IIINorway, Finland, Lithuania, Estonia
-
MedImmune LLCCompletedAdvanced Solid TumorsUnited States, France, Spain, Switzerland
-
Yonsei UniversityNot yet recruitingNon Small Cell Lung CancerKorea, Republic of
-
AstraZenecaCompleted