Description:
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.
Title
- Brief Title: A Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients With Resectable Non-small Cell Lung Cancer
- 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)
Clinical Trial IDs
- ORG STUDY ID:
D9106C00001
- NCT ID:
NCT03800134
Conditions
- Non-Small Cell Lung Cancer
Interventions
Drug | Synonyms | Arms |
---|
Durvalumab | MEDI4736 | Arm 1: Durvalumab + platinum-based chemotherapy |
Carboplatin/Paclitaxel | | Arm 1: Durvalumab + platinum-based chemotherapy |
Cisplatin/Gemcitabine | | Arm 1: Durvalumab + platinum-based chemotherapy |
Pemetrexed/Cisplatin | | Arm 1: Durvalumab + platinum-based chemotherapy |
Pemetrexed/Carboplatin | | Arm 1: Durvalumab + platinum-based chemotherapy |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Arm 1: Durvalumab + platinum-based chemotherapy | Experimental | 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 | - Durvalumab
- Carboplatin/Paclitaxel
- Cisplatin/Gemcitabine
- Pemetrexed/Cisplatin
- Pemetrexed/Carboplatin
|
Arm 2: Placebo + platinum-based chemotherapy | Placebo Comparator | 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 | - Carboplatin/Paclitaxel
- Cisplatin/Gemcitabine
- Pemetrexed/Cisplatin
- Pemetrexed/Carboplatin
|
Eligibility Criteria
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
Maximum Eligible Age: | 120 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Pathological Complete Response (pCR) in modified intent-to-treat (mITT) |
Time Frame: | From screening pathology to an average of 15 weeks after first dose. |
Safety Issue: | |
Description: | Defined as the lack of any viable tumour cells after complete evaluation in the resected lung cancer specimen and all sampled regional lymph nodes. |
Secondary Outcome Measures
Measure: | Disease-free survival (DFS) in modified resected population |
Time Frame: | From date of randomization to 5.5 years after date of resection |
Safety Issue: | |
Description: | |
Measure: | Major Pathological Response (mPR) |
Time Frame: | From screening pathology to an average of 15 weeks after first dose. |
Safety Issue: | |
Description: | |
Measure: | Overall Survival (OS) |
Time Frame: | From date of randomization to 5.5 years after randomization |
Safety Issue: | |
Description: | |
Measure: | Event-free survival (EFS) in PD-L1-TC ≥1% positive patients |
Time Frame: | From date of randomization to 5.5 years after randomization |
Safety Issue: | |
Description: | |
Measure: | pCR in PD-L1-TC ≥1% positive patients |
Time Frame: | From screening pathology to an average of 15 weeks after first dose |
Safety Issue: | |
Description: | |
Measure: | Disease-Free Survival (DFS) in PD-L1-TC ≥1% positive patients |
Time Frame: | From date of randomization to 5.5 years after date of resection |
Safety Issue: | |
Description: | |
Measure: | Major Pathological Response (mPR) in PD-L1-TC ≥1% positive patients |
Time Frame: | From screening pathology to an average of 15 weeks after first dose. |
Safety Issue: | |
Description: | |
Measure: | Overall Survival (OS) in PD-L1-TC ≥1% positive patients |
Time Frame: | From date of randomization to 5.5 years after randomization. |
Safety Issue: | |
Description: | |
Measure: | 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 |
Safety Issue: | |
Description: | To assess disease-related symptoms, functioning, and global health status/quality of life in patients. |
Measure: | 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 |
Safety Issue: | |
Description: | To assess disease-related symptoms, functioning, and global health status/quality of life in patients. |
Measure: | To assess the PK of durvalumab in blood (through concentration) |
Time Frame: | From date of randomization to 2 months after resection |
Safety Issue: | |
Description: | To assess concentration of durvalumab in bloodstream. |
Measure: | Presence of ADA for durvalumab |
Time Frame: | From date of randomization to 3 months after last dose of IP |
Safety Issue: | |
Description: | To evaluate the presence of antibodies following treatment with study medications. |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | AstraZeneca |
Trial Keywords
- Resectable Non-small Cell Lung Cancer, NSCLC, Carcinoma, Non-small Cell Lung Cancer
Last Updated
August 24, 2021