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)
- Conditions
- non small-cell lung cancerlung cancer10038666
- Registration Number
- NL-OMON52504
- Lead Sponsor
- Astra Zeneca
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 275
1. Age >=18 years 2. Newly diagnosed and previously untreated patients with
histologicallyor 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-PD-L2 antibodies, excluding therapeutic
anticancer vaccines. 6. Adequate organ and marrow function 7. Confirmation of a
patients tumour PD-L1 status 8. Provision of sufficient tumour biopsy sample
for evaluation and confirmation of EGFR and ALK status 9. Planned surgery to be
performed need to include lobectomy, sleeve resection or bilobectomy.10. A pre-
or post-bronchodilator FEV of 1.0 L and >40% post-operative predicted value.
1. History of allogeneic organ transplantation
2. Active or prior documented autoimmune or inflammatory disorders (including
inflammatory bowel disease, diverticulitis, systemic lupus erythematosus,
Sarcoidosis syndrome, or Wegener syndrome).
3. History of another primary malignancy
4. History of active primary immunodeficiency
5. . Active infection including tuberculosis hepatitis B and C, or human
immunodeficiency virus
6. Deemed unresectable NSCLC by multidisciplinary evaluation
7. Patients who have pre-operative radiotherapy treatment as part of their care
plan
8. Patients who have brain metastases or spinal cord compression
9. Stage IIIB N3 and Stages IIIC, IVA, and IVB NSCLC
10. Known allergy or hypersensitivity to any of the study drugs or
excipients11. Existence of more than one primary tumour such as mixed small
cell and NSCLC histology12. Patients who are candidates to undergo only
pneumonectomy, segmentectomies or wedge resections.13. Patients with a
documented test result confirming the presence of EGFRm or ALK translocation.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- To compare the efficacy of durvalumab + chemotherapy administered prior to<br /><br>surgery followed by durvalumab post-surgery compared with placebo +<br /><br>chemotherapy administered prior to surgery followed by placebo post-surgery in<br /><br>terms of EFS (event-free survival)<br /><br><br /><br>- To compare the activity of durvalumab + chemotherapy administered prior to<br /><br>surgery compared with placebo + chemotherapy administered<br /><br>prior to surgery in terms of mPR(major pathologic response = 10% or less<br /><br>residual viable tumor tissue in lung primary tumor after neoadjuvant treatment<br /><br>at the time of resection) </p><br>
- Secondary Outcome Measures
Name Time Method <p>- To compare the efficacy of perioperative durvalumab + neoadjuvant<br /><br>chemotherapy compared with placebo + neoadjuvant chemotherapy in<br /><br>terms of DFS<br /><br>- To compare the efficacy of perioperative durvalumab + neoadjuvant<br /><br>chemotherapy compared with placebo + neoadjuvant chemotherapy in<br /><br>terms of MPR<br /><br>- To compare the efficacy of perioperative durvalumab + neoadjuvant<br /><br>chemotherapy compared with placebo + neoadjuvant chemotherapy in<br /><br>terms of OS<br /><br>- To compare the efficacy of perioperative durvalumab + neoadjuvant<br /><br>chemotherapy compared with placebo + neoadjuvant chemotherapy in<br /><br>patients with PD-L1 TC >=1% tumors in terms of EFS, pCR, DFS, MPR and OS<br /><br>- To assess disease-related symptoms and HRQOL in patients treated with<br /><br>perioperative durvalumab + neoadjuvant chemotherapy compared<br /><br>with placebo + neoadjuvant chemotherapy<br /><br>- To assess the PK and immunogenicity of durvalumab</p><br>