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

Sponsor
AstraZeneca (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03800134
Collaborator
(none)
816
Enrollment
242
Locations
2
Arms
64.8
Anticipated Duration (Months)
3.4
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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 pathological complete response.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
816 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 :
Dec 6, 2018
Anticipated Primary Completion Date :
Apr 30, 2024
Anticipated Study Completion Date :
Apr 30, 2024

Arms and Interventions

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 Names:
  • 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

    Primary Outcome Measures

    1. Pathological Complete Response (pCR) in modified intent-to-treat (mITT) [From screening pathology to an average of 15 weeks after first dose.]

      Defined as the lack of any viable tumour cells after complete evaluation in the resected lung cancer specimen and all sampled regional lymph nodes.

    2. Event-Free Survival (EFS) [Up to 5.5 years after first patient randomized.]

      An event defined as documented RECIST 1.1 local or distant recurrence of lung cancer; death due to any cause; disease progression that precludes surgery or discovered upon attempting surgery that prevents completion of surgery.

    Secondary Outcome Measures

    1. Disease-free survival (DFS) in modified resected population [From date of randomization to 5.5 years after date of resection]

    2. Major Pathological Response (mPR) [From screening pathology to an average of 15 weeks after first dose.]

    3. Overall Survival (OS) [From date of randomization to 5.5 years after randomization]

    4. Event-free survival (EFS) in PD-L1-TC ≥1% positive patients [From date of randomization to 5.5 years after randomization]

    5. pCR in PD-L1-TC ≥1% positive patients [From screening pathology to an average of 15 weeks after first dose]

    6. Disease-Free Survival (DFS) in PD-L1-TC ≥1% positive patients [From date of randomization to 5.5 years after date of resection]

    7. Major Pathological Response (mPR) in PD-L1-TC ≥1% positive patients [From screening pathology to an average of 15 weeks after first dose.]

    8. Overall Survival (OS) in PD-L1-TC ≥1% positive patients [From date of randomization to 5.5 years after randomization.]

    9. 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 [From date of screening to 6 months after last dose of IP]

      To assess disease-related symptoms, functioning, and global health status/quality of life in patients.

    10. 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 [From date of screening to 6 months after last dose of IP]

      To assess disease-related symptoms, functioning, and global health status/quality of life in patients.

    11. To assess the PK of durvalumab in blood (through concentration) [From date of randomization to 2 months after resection]

      To assess concentration of durvalumab in bloodstream.

    12. Presence of ADA for durvalumab [From date of randomization to 3 months after last dose of IP]

      To evaluate the presence of antibodies following treatment with study medications.

    Other Outcome Measures

    1. Number of participants with all adverse events as assessed by CTCAE v5.0 [64 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 120 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Age ≥18 years

    • Newly diagnosed and previously untreated patients with 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 patient's tumour PD-L1 status

    • Provision of sufficient tumour biopsy sample for evaluation and confirmation of EGFR and ALK status

    • Planned surgery must comprise lobectomy, sleeve resection, or bilobectomy

    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 and C, 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

    • Known allergy or hypersensitivity to any of the study drugs or excipients

    • Existence of more than one primary tumour such as mixed small cell and NSCLC histology

    • Patients whose planned surgery at enrollment includes any of the following procedures: pneumonectomy, segmentectomies, or wedge resections

    • Patients with a documented test result confirming the presence of EGFRm or ALK translocation

    Contacts and Locations

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    Sponsors and Collaborators

    • AstraZeneca

    Investigators

    • Principal Investigator: John Heymach, MD, UT MD Anderson Cancer Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AstraZeneca
    ClinicalTrials.gov Identifier:
    NCT03800134
    Other Study ID Numbers:
    • D9106C00001
    First Posted:
    Jan 11, 2019
    Last Update Posted:
    Aug 17, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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:
    Lung Neoplasms
    Carcinoma, Non-Small-Cell Lung
    Gemcitabine
    Paclitaxel
    Cisplatin
    Carboplatin
    Pemetrexed
    Durvalumab

    Study Results

    No Results Posted as of Aug 17, 2022