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NCT Number: NCT03800134

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Durvalumab

Drug

1500mg on Day 1 of each 3-week cycle for 4 cycles during the neoadjuvant period and 1500mg on Day 1 of each 4-week cycle for 12 cycles during the adjuvant period

Other names: MEDI4736

Placebo

Other

Day 1 of each 3-week cycle for 4 cycles during the neoadjuvant period and Day 1 of each 4-week cycle for 12 cycles during the adjuvant period

carboplatin

Drug

Area under the curve of 5/6 on Day 1 of each 3-week cycle for 4 cycles

Cisplatin

Drug

75 mg/m2 on Day 1 of each 3-week cycle, for 4 cycles

Pemetrexed

Drug

500 mg/m2 on Day 1 of each 3-week cycle for 4 cycles.

paclitaxel

Drug

200mg/m2 on Day 1 of each 3-week cycle for 4 cycles.

Gemcitabine

Drug

1250 mg/m2 on Day 1 and Day 8 of each 3-week cycle, for 4 cycles.

Surgery

Procedure

Expected within 40 days from the last dose of Investigational Product following the completion of neoadjuvant treatment.

Primary outcomes

  1. Pathological Complete Response (pCR) in modified intent-to-treat (mITT) population

    Time frame: Up to approximately 15 weeks after randomization

    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) in modified intent to treat (mITT) population

    Time frame: Up to 5.5 years after first patient randomized.

    An event is 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 outcomes

  1. Disease-free survival (DFS) in modified resected population

    Time frame: From date of randomization to approximately 5.5 years after date of resection

  2. Major Pathological Response (mPR) in modified intent to treat (mITT) population

    Time frame: Up to approximately 15 weeks after randomization

  3. Overall Survival (OS) in modified intent to treat (mITT) population

    Time frame: From date of randomization to 5.5 years after randomization

  4. Event-free survival (EFS) in PD-L1-TC ≥1% patients in modified intent to treat (mITT) population

    Time frame: From date of randomization to 5.5 years after randomization

  5. pCR in PD-L1-TC ≥1% patients in modified intent to treat (mITT) population

    Time frame: Up to approximately 15 weeks after randomization

  6. Disease-Free Survival (DFS) in PD-L1-TC ≥1% patients in modified resected population

    Time frame: From date of randomization to 5.5 years after date of resection

  7. Major Pathological Response (mPR) in PD-L1-TC ≥1% patients in modified intent to treat (mITT) population

    Time frame: Up to approximately 15 weeks after randomization

  8. Overall Survival (OS) in PD-L1-TC ≥1% patients in modified intent to treat (mITT) population

    Time frame: 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 durvalumab + chemotherapy prior to surgery followed by durvalumab post-surgery compared with placebo + chemotherapy prior to surgery followed by placebo post-surgery

    Time frame: 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 durvalumab + chemotherapy prior to surgery followed by durvalumab post-surgery compared with placebo + chemotherapy prior to surgery followed by placebo post-surgery

    Time frame: 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

    Time frame: From date of randomization to 2 months after resection

    To assess concentration of durvalumab in bloodstream.

  12. Presence of ADA for durvalumab

    Time frame: From date of randomization to 3 months after last dose of IP

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

Other outcomes

  1. Number of participants with adverse events as assessed by CTCAE v5.0

    Time frame: From date of randomization to 3 months after last dose of IP

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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)

Acronym: AEGEAN

Important dates

Study start
2018
Primary completion
2022
Study completion
2028
First posted
Jan 11, 2019
Registry last updated
Jun 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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