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Clinical Trials List

Protocol NumberD9106C00001
NCT Number(ClinicalTrials.gov Identfier)NCT03800134
Active

2018-11-02 - 2028-12-31

Phase III

Recruiting6

Terminated3

ICD-10C34

Malignant neoplasm of bronchus and lung

ICD-9162.9

Malignant neoplasm of bronchus and lung, unspecified

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)

  • Trial Applicant

  • Sponsor

    AstraZeneca Taiwan Limited

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator TSUNG -YING YANG Division of Thoracic Medicine
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 吳銘芳 Division of Thoracic Medicine
Chung Shan Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Han-Pin Kuo Division of Thoracic Medicine
Taipei Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

2 Recruiting

Audit

None

Principal Investigator Chien-Chung Lin Division of Thoracic Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator kang-Yun LEE Division of Thoracic Medicine
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

10 Recruiting

Audit

CRO

Principal Investigator Chong-Jen Yu Division of Thoracic Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Audit

None

Principal Investigator Cheng-Ta Yang Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator 陳昭勳 Division of Hematology & Oncology
Chi Mei Hospital, Liouying

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 林聖皓 Division of Thoracic Medicine
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Condition/Disease

Neoadjuvant/adjuvant Durvalumab for the Treatment of Patients with Resectable Stages II and III Non-small Cell Lung Cancer

Objectives

Primary objective: To assess the activity of durvalumab + chemotherapy administered prior to surgery compared with placebo + chemotherapy administered prior to surgery in terms of mPR Secondary objectives: To assess the activity of durvalumab + chemotherapy administered prior to surgery compared with placebo + chemotherapy administered prior to surgery in terms of pCR To assess the activity of durvalumab + chemotherapy administered prior to surgery compared with placebo + chemotherapy administered prior to surgery in terms of mPR To assess the efficacy of durvalumab + chemotherapy administered prior to surgery followed by durvalumab post-surgery compared with placebo + chemotherapy administered prior to surgery followed by placebo post-surgery in terms of EFS, DFS, and OS To assess disease-related symptoms and HRQoL in patients treated with durvalumab + chemotherapy administered prior to surgery followed by durvalumab post-surgery compared with placebo + chemotherapy administered prior to surgery followed by placebo post-surgery To assess the PK of durvalumab To investigate the immunogenicity of durvalumab Safety objective: To assess the safety and tolerability profile of durvalumab + chemotherapy administered prior to surgery followed by durvalumab post-surgery compared with placebo + chemotherapy administered prior to surgery followed by placebo post-surgery

Test Drug

Durvalumab (MEDI4736)

Active Ingredient

Humanized anti-PD-1 mAb

Dosage Form

solution of injection

Dosage

500mg

Endpoints

Primary objective:
To assess the activity of durvalumab + chemotherapy administered prior to surgery compared with placebo + chemotherapy administered prior to surgery in terms of mPR

Secondary objectives:
To assess the activity of durvalumab + chemotherapy administered prior to surgery compared with placebo + chemotherapy administered prior to surgery in terms of pCR
To assess the activity of durvalumab + chemotherapy administered prior to surgery compared with placebo + chemotherapy administered prior to surgery in terms of mPR
To assess the efficacy of durvalumab + chemotherapy administered prior to surgery followed by durvalumab post-surgery compared with placebo + chemotherapy administered prior to surgery followed by placebo post-surgery in terms of EFS, DFS, and OS
To assess disease-related symptoms and HRQoL in patients treated with durvalumab + chemotherapy administered prior to surgery followed by durvalumab post-surgery compared with placebo + chemotherapy administered prior to surgery followed
by placebo post-surgery
To assess the PK of durvalumab
To investigate the immunogenicity of durvalumab

Safety objective:
To assess the safety and tolerability profile of durvalumab + chemotherapy administered prior to surgery followed by durvalumab post-surgery compared with placebo + chemotherapy administered prior to surgery followed by placebo post-surgery

Inclution Criteria

1.Age ≥18 years
2.Histologically or cytologically documented NSCLC with resectable (Stage IIA to select [ie, N2] Stage IIIB) disease
3.World Health Organization (WHO)/ECOG PS of 0 or 1 at enrollment
4.At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 Target Lesion (TL) at baseline
5.No prior exposure to immune-mediated therapy including, but not limited to, other anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti-6.PD-L2 antibodies, excluding therapeutic anticancer vaccines
7.Adequate organ and marrow function
8.Confirmation of a patients tumour PD-L1 status
9.Documented EGFR and ALK status

Exclusion Criteria

1.History of allogeneic organ transplantation
2.Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease, diverticulitis, 3.systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome)
4.History of another primary malignancy
5.History of active primary immunodeficiency
6.Active infection including tuberculosis hepatitis B, or human immunodeficiency virus
7.Deemed unresectable NSCLC by multidisciplinary evaluation
8.Patients who have pre-operative radiotherapy treatment as part of their care plan
9.Patients who have brain metastases or spinal cord compression
10.Stage IIIB N3 and Stages IIIC, IVA, and IVB NSCLC
11.Mixed small cell and NSCLC histology
12.Patients who are candidates to undergo only segmentectomies or wedge resections

The Estimated Number of Participants

  • Taiwan

    40 participants

  • Global

    800 participants

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