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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05221840




Registration number
NCT05221840
Ethics application status
Date submitted
14/01/2022
Date registered
3/02/2022

Titles & IDs
Public 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
Scientific 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
Secondary ID [1] 0 0
2023-503999-24-00
Secondary ID [2] 0 0
D9078C00001
Universal Trial Number (UTN)
Trial acronym
PACIFIC-9
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Durvalumab
Treatment: Drugs - Oleclumab
Treatment: Drugs - Monalizumab
Other interventions - Placebo

Experimental: Arm A: Durvalumab and Oleclumab - 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

Experimental: Arm B: Durvalumab and Monalizumab - 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

Active comparator: Arm C: Durvalumab and 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


Treatment: Drugs: Durvalumab
Durvalumab IV (intravenous infusion)

Treatment: Drugs: Oleclumab
Oleclumab IV (intravenous infusion)

Treatment: Drugs: Monalizumab
Monalizumab IV (intravenous infusion)

Other interventions: Placebo
Placebo IV (intravenous infusion)
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Surival (PFS)
Timepoint [1] 0 0
Up to 5 years after first patient randomized.
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Up to 9 years after first patient randomized
Secondary outcome [2] 0 0
Objective response rate (ORR)
Timepoint [2] 0 0
Up to 5 years after first patient randomized
Secondary outcome [3] 0 0
Overall survival (OS) at 24 months
Timepoint [3] 0 0
Up to 9 years after first patient randomized
Secondary outcome [4] 0 0
Duration of response (DoR)
Timepoint [4] 0 0
Up to 5 years after first patient randomized
Secondary outcome [5] 0 0
Progression free survival (PFS) at 6, 12, 18, and 24 months
Timepoint [5] 0 0
From date of randomization until 24 months
Secondary outcome [6] 0 0
Time from randomization to second progression (PFS2)
Timepoint [6] 0 0
Up to 5 years after first patient randomized
Secondary outcome [7] 0 0
Time from randomization to first date of distant metastasis or death (TTDM)
Timepoint [7] 0 0
Up to 5 years after first patient randomized
Secondary outcome [8] 0 0
Time from randomization to start date of first subsequent therapy (TFST)
Timepoint [8] 0 0
Up to 9 years after first patient randomized
Secondary outcome [9] 0 0
Progression free survival (PFS) as assessed by Investigator
Timepoint [9] 0 0
Up to 5 years after first patient randomized
Secondary outcome [10] 0 0
IHC analysis of PD-L1 TC expression
Timepoint [10] 0 0
Up to 5 years after first patient randomized
Secondary outcome [11] 0 0
Concentration of Durvalumab
Timepoint [11] 0 0
From date of randomization until 3 months after date of last IP dose
Secondary outcome [12] 0 0
Anti-drug antibodies (ADAs)
Timepoint [12] 0 0
From date of randomization until 3 months after date of last IP dose
Secondary outcome [13] 0 0
Time to deterioration in pulmonary symptoms (TTFCD)
Timepoint [13] 0 0
Up to 5 years after last patient randomized
Secondary outcome [14] 0 0
Concentration of Oleclumab
Timepoint [14] 0 0
From date of randomization until 3 months after last dose of IP
Secondary outcome [15] 0 0
Concentration of Monalizumab
Timepoint [15] 0 0
From date of randomization until 3 months after last dose of IP

Eligibility
Key inclusion criteria
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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/02/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/05/2030
Actual
Sample size
Target
999
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Box Hill
Recruitment hospital [2] 0 0
Research Site - East Melbourne
Recruitment hospital [3] 0 0
Research Site - Elizabeth Vale
Recruitment hospital [4] 0 0
Research Site - Gosford
Recruitment hospital [5] 0 0
Research Site - Heidelberg
Recruitment hospital [6] 0 0
Research Site - Kogarah
Recruitment hospital [7] 0 0
Research Site - South Brisbane
Recruitment hospital [8] 0 0
Research Site - St Albans
Recruitment hospital [9] 0 0
Research Site - St. Leonards
Recruitment hospital [10] 0 0
Research Site - Westmead
Recruitment postcode(s) [1] 0 0
3128 - Box Hill
Recruitment postcode(s) [2] 0 0
3002 - East Melbourne
Recruitment postcode(s) [3] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [4] 0 0
2250 - Gosford
Recruitment postcode(s) [5] 0 0
3084 - Heidelberg
Recruitment postcode(s) [6] 0 0
2217 - Kogarah
Recruitment postcode(s) [7] 0 0
4101 - South Brisbane
Recruitment postcode(s) [8] 0 0
3021 - St Albans
Recruitment postcode(s) [9] 0 0
2065 - St. Leonards
Recruitment postcode(s) [10] 0 0
2145 - Westmead
Recruitment outside Australia
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United States of America
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California
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Connecticut
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Illinois
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Indiana
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Iowa
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Kentucky
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Maine
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Valencia
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Hsinchu
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Ankara
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Diyarbakir
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Goztepe Istanbul
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Kyiv
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Uzhgorod
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Ukraine
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Zaporizhzhia
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Belfast
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Bristol
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Dundee
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Edinburgh
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Hampshire
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London
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Middlesborough
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Poole
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Rhyl
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Torquay
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Truro
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Wolverhampton
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Vietnam
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Hai Phong
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Vietnam
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Hanoi
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Vietnam
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Ho Chi Minh city
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Vietnam
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Ho Chi Minh

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Fabrice Barlesi, MD
Address 0 0
Gustave Roussy, Cancer Campus, Grand Paris
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
AstraZeneca Clinical Study Information Center
Address 0 0
Country 0 0
Phone 0 0
1-877-240-9479
Fax 0 0
Email 0 0
information.center@astrazeneca.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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 document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Available to whom?
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05221840