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A Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients With Resectable Non-small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT03800134
Recruitment Status : Recruiting
First Posted : January 11, 2019
Last Update Posted : February 21, 2021
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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Brief Summary:
This is a Phase III, randomized, double-blind, placebo-controlled, multi-center international study assessing the activity of durvalumab and chemotherapy administered prior to surgery compared with placebo and chemotherapy administered prior to surgery in terms of major pathological response.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Drug: Durvalumab Other: Placebo Drug: Carboplatin/Paclitaxel Drug: Cisplatin/Gemcitabine Drug: Pemetrexed/Cisplatin Drug: Pemetrexed/Carboplatin Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: A Phase III, Double-blind, Placebo-controlled, Multi-center International Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients With Resectable Stages II and III Non-small Cell Lung Cancer (AEGEAN)
Actual Study Start Date : December 6, 2018
Estimated Primary Completion Date : April 30, 2024
Estimated Study Completion Date : April 30, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Durvalumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm 1: Durvalumab + platinum-based chemotherapy

Durvalumab ((MEDI4736) in concurrence with platinum-based chemotherapy.

All patients will receive 1 of the following platinum-based standard of care chemotherapy options, based on tumour histology and Investigator discretion:

  • carboplatin/paclitaxel
  • cisplatin/gemcitabine
  • pemetrexed/cisplatin
  • pemetrexed/carboplatin
 Drug: Durvalumab
Durvalumab IV (intravenous infusion)
Other Name: MEDI4736

Drug: Carboplatin/Paclitaxel
Carboplatin/Paclitaxel, as per standard of care

Drug: Cisplatin/Gemcitabine
Cisplatin/Gemcitabine, as per standard of care

Drug: Pemetrexed/Cisplatin
Pemetrexed/Cisplatin, as per standard of care

Drug: Pemetrexed/Carboplatin
Pemetrexed/Carboplatin, as per standard of care
Placebo Comparator: Arm 2: Placebo + platinum-based chemotherapy

Placebo in concurrence with platinum-based chemotherapy.

All patients will receive 1 of the following platinum-based standard of care chemotherapy options, based on tumour histology and Investigator discretion:

  • carboplatin/paclitaxel
  • cisplatin/gemcitabine
  • pemetrexed/cisplatin
  • pemetrexed/carboplatin
 Other: Placebo
Placebo IV (intravenous infusion)

Drug: Carboplatin/Paclitaxel
Carboplatin/Paclitaxel, as per standard of care

Drug: Cisplatin/Gemcitabine
Cisplatin/Gemcitabine, as per standard of care

Drug: Pemetrexed/Cisplatin
Pemetrexed/Cisplatin, as per standard of care

Drug: Pemetrexed/Carboplatin
Pemetrexed/Carboplatin, as per standard of care


Outcome Measures
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Primary Outcome Measures :
  1. Major Pathological Response (mPR) [ Time Frame: From screening pathology to an average of 15 weeks after first dose. ]
  2. Event-free survival [ Time Frame: Up to 5 years after first patient enrolled. ]

Secondary Outcome Measures :
  1. Pathological complete response (pCR) [ Time Frame: From screening pathology to an average of 15 weeks after first dose. ]
  2. mPR in PD-L1-TC positive patients [ Time Frame: From screening pathology to an average of 15 weeks after first dose ]
  3. Event-free survival (EFS) [ Time Frame: From date of randomization to 5.5 years after randomization ]
  4. Disease-free survival (DFS) [ Time Frame: From date of randomization to 5.5 years after date of resection ]
  5. Overall Survival (OS) [ Time Frame: From date of randomization to 5.5 years after randomization ]
  6. To assess disease-related symptoms and HRQoL (EORTC QLQ-C30) in patients treated with durva + chemo prior to surgery followed by durva post-surgery compared with placebo + chemo prior to surgery followed by placebo post-surgery [ Time Frame: From date of screening to 6 months after last dose of IP ]
  7. To assess disease-related symptoms and HRQoL (EORTC QLQ-LC13) in patients treated with durva + chemo prior to surgery followed by durva post-surgery compared with placebo + chemo prior to surgery followed by placebo post-surgery [ Time Frame: From date of screening to 6 months after last dose of IP ]
  8. To assess the PK of durvalumab in blood (through concentration) [ Time Frame: From date of randomization to 2 months after resection ]
  9. Presence of ADA for durvalumab [ Time Frame: From date of randomization to 3 months after last dose of IP ]
  10. EFS and DFS in PD-L1 TC positive patients [ Time Frame: From date of resection up to 5.5 years after date of resection. ]

Other Outcome Measures:
  1. Number of participants with all adverse events as assessed by CTCAE v4.0 in durva + chemo prior to surgery followed by durva post-surgery compared with placebo + chemo prior to surgery followed by placebo post-surgery [ Time Frame: 64 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥18 years
  • Histologically or cytologically documented NSCLC with resectable (Stage IIA to select [ie, N2] Stage IIIB) disease
  • World Health Organization (WHO)/ECOG PS of 0 or 1 at enrollment
  • At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 Target Lesion (TL) at baseline
  • No prior exposure to immune-mediated therapy including, but not limited to, other anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies, excluding therapeutic anticancer vaccines
  • Adequate organ and marrow function
  • Confirmation of a patients tumour PD-L1 status
  • Documented EGFR and ALK status

Exclusion Criteria:

  • History of allogeneic organ transplantation
  • Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease, diverticulitis, systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome)
  • History of another primary malignancy
  • History of active primary immunodeficiency
  • Active infection including tuberculosis hepatitis B, or human immunodeficiency virus
  • Deemed unresectable NSCLC by multidisciplinary evaluation
  • Patients who have pre-operative radiotherapy treatment as part of their care plan
  • Patients who have brain metastases or spinal cord compression
  • Stage IIIB N3 and Stages IIIC, IVA, and IVB NSCLC
  • Mixed small cell and NSCLC histology
  • Patients who are candidates to undergo only segmentectomies or wedge resections
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03800134


Contacts
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Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com
Contact: AstraZeneca Cancer Study Locator 1-877-400-4656 astrazeneca@emergingmed.com

Locations
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Sponsors and Collaborators
AstraZeneca
Investigators
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Principal Investigator: John Heymach, MD UT MD Anderson Cancer Institute
More Information
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT03800134    
Other Study ID Numbers: D9106C00001
First Posted: January 11, 2019    Key Record Dates
Last Update Posted: February 21, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Supporting Materials: 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 refer 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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AstraZeneca:
Resectable Non-small Cell Lung Cancer, NSCLC, Carcinoma, Non-small Cell Lung Cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Gemcitabine
Paclitaxel
Cisplatin
Carboplatin
Pemetrexed
 Durvalumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs