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History of Changes for Study: NCT05221840
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 (PACIFIC-9)
Latest version (submitted May 16, 2024) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 February 2, 2022 None (earliest Version on record)
2 February 11, 2022 Recruitment Status, Contacts/Locations, Arms and Interventions, Study Status, Outcome Measures, Study Design and Oversight
3 March 24, 2022 Contacts/Locations and Study Status
4 April 25, 2022 Contacts/Locations and Study Status
5 June 1, 2022 Contacts/Locations, Study Status and Study Design
6 July 1, 2022 Contacts/Locations and Study Status
7 July 22, 2022 Contacts/Locations and Study Status
8 September 2, 2022 Contacts/Locations and Study Status
9 October 11, 2022 Contacts/Locations and Study Status
10 March 29, 2023 Contacts/Locations, Study Status, Eligibility and Study Identification
11 May 16, 2023 Contacts/Locations and Study Status
12 June 14, 2023 Contacts/Locations and Study Status
13 July 19, 2023 Contacts/Locations and Study Status
14 August 16, 2023 Contacts/Locations and Study Status
15 September 11, 2023 Contacts/Locations and Study Status
16 October 6, 2023 Contacts/Locations and Study Status
17 November 3, 2023 Contacts/Locations and Study Status
18 December 5, 2023 Contacts/Locations, References and Study Status
19 December 21, 2023 Contacts/Locations and Study Status
20 January 17, 2024 Contacts/Locations and Study Status
21 February 15, 2024 Contacts/Locations and Study Status
22 March 14, 2024 Contacts/Locations and Study Status
23 April 15, 2024 Study Status and Contacts/Locations
24 May 16, 2024 Contacts/Locations and Study Status
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Study NCT05221840
Submitted Date:  February 2, 2022 (v1)

Open or close this module Study Identification
Unique Protocol ID: D9078C00001
Brief 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 (PACIFIC-9)
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
Secondary IDs: 2021-004346-37 [EudraCT Number]
Open or close this module Study Status
Record Verification: February 2022
Overall Status: Not yet recruiting
Study Start: February 18, 2022
Primary Completion: June 18, 2026 [Anticipated]
Study Completion: October 18, 2030 [Anticipated]
First Submitted: January 14, 2022
First Submitted that
Met QC Criteria:
February 2, 2022
First Posted: February 3, 2022 [Actual]
Last Update Submitted that
Met QC Criteria:
February 2, 2022
Last Update Posted: February 3, 2022 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: AstraZeneca
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief 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.
Detailed Description:
Open or close this module Conditions
Conditions: Non-Small Cell Lung Cancer
Keywords: Non-Small Cell Lung Cancer
Locally Advanced NSCLC
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 3
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 1000 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Arm A
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
Drug: durvalumab
durvalumab IV (intravenous infusion)
Drug: Oleclumab
Oleclumab IV (intravenous infusion)
Experimental: Arm B
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
Drug: durvalumab
durvalumab IV (intravenous infusion)
Drug: Monalizumab
Monalizumab IV (intravenous infusion)
Placebo
Placebo IV (intravenous infusion)
Active Comparator: Arm C
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
Drug: durvalumab
durvalumab IV (intravenous infusion)
Placebo
Placebo IV (intravenous infusion)
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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.
Secondary Outcome Measures:
1. Overall Survival (OS)
[ Time Frame: Up to 9 years after first patient randomized ]

Overall survival (OS)
2. Objective response rate (ORR)
[ Time Frame: 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
[ Time Frame: Up to 9 years after first patient randomized ]

Overall survival (OS) at 24 months
4. Duration of response (DoR)
[ Time Frame: 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
[ Time Frame: Up to 5 years after first patient randomized ]

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)
[ Time Frame: 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)
[ Time Frame: 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)
[ Time Frame: 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
[ Time Frame: Up to 5 years after first patient randomized ]

Progression free survival (PFS) as assessed by Investigator
10. IHC analysis of PD-L1 TC expression
[ Time Frame: Up to 5 years after first patient randomized ]

IHC analysis of PD-L1 TC expression relative to efficacy outcomes
11. Concentration of Durvalumab
[ Time Frame: 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)
[ Time Frame: 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)
[ Time Frame: Up to 5 years after last patient randomized ]

Time to deterioration in pulmonary symptoms (TTFCD)
14. Concentration of Oleclumab
[ Time Frame: 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
[ Time Frame: 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
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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, basal cell carcinoma of the skin, squamous cell carcinoma of the skin or lentigo maligna that has undergone potentially curative therapy, adequately treated carcinoma in situ or Ta tumours treated with curative intent and 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, organizing pneumonia, drug induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis, ILD, pleural effusion, or 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.
Open or close this module Contacts/Locations
Central Contact Person: AstraZeneca Clinical Study Information Center
Telephone: 1-877-240-9479
Email: information.center@astrazeneca.com
Locations: United States, California
Research Site
San Diego, California, United States, 92123
United States, Kentucky
Research Site
Lexington, Kentucky, United States, 40503
United States, Michigan
Research Site
Grand Rapids, Michigan, United States, 49503
United States, Montana
Research Site
Billings, Montana, United States, 59101
United States, Oregon
Research Site
Portland, Oregon, United States, 97239
United States, Pennsylvania
Research Site
Philadelphia, Pennsylvania, United States, 19104
United States, Virginia
Research Site
Charlottesville, Virginia, United States, 22908
Research Site
Richmond, Virginia, United States, 23230
United States, Washington
Research Site
Tacoma, Washington, United States, 98415
Australia
Research Site
Elizabeth Vale, Australia, 5112
Canada, Ontario
Research Site
Hamilton, Ontario, Canada, L8V 5C2
Research Site
London, Ontario, Canada, N6A 5W9
Research Site
Toronto, Ontario, Canada, M5G 2M9
Japan
Research Site
Natori-shi, Japan, 981-1293
Research Site
Osaka-shi, Japan, 541-8567
Research Site
Tokushima-shi, Japan, 770-8503
Research Site
Wakayama-shi, Japan, 641-8510
Korea, Republic of
Research Site
Changwon-si, Korea, Republic of, 51353
Research Site
Cheongju-si, Korea, Republic of, 28644
Research Site
Seongnam-si, Korea, Republic of, 13620
Research Site
Seoul, Korea, Republic of, 03080
Research Site
Seoul, Korea, Republic of, 05505
Research Site
Suwon, Korea, Republic of, 16247
Research Site
Suwon-si, Korea, Republic of, 16499
Spain
Research Site
Barcelona, Spain, 08035
Research Site
Barcelona, Spain, 8003
Research Site
Granada, Spain, 18016
Research Site
Madrid, Spain, 28034
Research Site
Madrid, Spain, 28040
Research Site
Santiago de Compostela, Spain, 15706
Research Site
Valencia, Spain, 46010
Taiwan
Research Site
Hsinchu, Taiwan, 300
Research Site
Taichung, Taiwan, 402
Research Site
Taichung, Taiwan, 40705
Research Site
Taipei, Taiwan, 100
Research Site
Taipei, Taiwan, 11490
Research Site
Taipei, Taiwan, 23561
Research Site
Taipei 112, Taiwan
Research Site
Taoyuan City, Taiwan, 333
Thailand
Research Site
Bangkok, Thailand, 10300
Research Site
Bangkok, Thailand, 10700
Research Site
Chonburi, Thailand, 20000
Research Site
Hat Yai, Thailand, 90110
Research Site
Khon Kaen, Thailand, 40000
Research Site
Khon Kaen, Thailand, 40002
Research Site
Lampang, Thailand, 52000
Research Site
Muang, Thailand, 22000
Research Site
Muang, Thailand, 50200
Research Site
Naimuang, Thailand, 30000
Ukraine
Research Site
Chernihiv, Ukraine, 14029
Research Site
Kharkiv Region, Ukraine, 61018
Research Site
Kropyvnytskyi, Ukraine, 25011
Research Site
Kyiv, Ukraine, 03680
Research Site
Uzhgorod, Ukraine, 88000
Research Site
Zaporizhzhia, Ukraine, 69000
United Kingdom
Research Site
Belfast, United Kingdom, BT9 7AB
Research Site
Bristol, United Kingdom, BS2 8ED
Research Site
Dundee, United Kingdom, DD1 9SY
Research Site
Edinburgh, United Kingdom, EH4 2XR
Research Site
Hampshire, United Kingdom, SO16 6YD
Research Site
London, United Kingdom, NW1 2PG
Research Site
Middlesbrough, United Kingdom, TS4 3BW
Research Site
Poole, United Kingdom, BH15 2JB
Research Site
Rhyl, United Kingdom, LL18 5UJ
Research Site
Torquay, United Kingdom, TQ2 7AA
Research Site
Truro, United Kingdom, TR1 3LJ
Research Site
Wolverhampton, United Kingdom, WV10 OQP
Open or close this module IPDSharing
Plan to Share IPD: Yes

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

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 Information:
Study Protocol
Statistical Analysis Plan (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 deidentified 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.
URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home
Open or close this module References
Citations:
Links:
Available IPD/Information:

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