Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2026-01-08 @ 7:05 PM
Study NCT ID:
NCT03800134
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-11
First Post:
2018-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients With Resectable Non-small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
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death due to any cause; disease progression that precludes surgery or discovered upon attempting surgery that prevents completion of surgery.'}], 'secondaryOutcomes': [{'measure': 'Disease-free survival (DFS) in modified resected population', 'timeFrame': 'From date of randomization to approximately 5.5 years after date of resection'}, {'measure': 'Major Pathological Response (mPR) in modified intent to treat (mITT) population', 'timeFrame': 'Up to approximately 15 weeks after randomization'}, {'measure': 'Overall Survival (OS) in modified intent to treat (mITT) population', 'timeFrame': 'From date of randomization to 5.5 years after randomization'}, {'measure': 'Event-free survival (EFS) in PD-L1-TC ≥1% patients in modified intent to treat (mITT) population', 'timeFrame': 'From date of randomization to 5.5 years after randomization'}, {'measure': 'pCR in PD-L1-TC ≥1% patients in modified intent to treat (mITT) population', 'timeFrame': 'Up to approximately 15 weeks after randomization'}, {'measure': 'Disease-Free Survival (DFS) in PD-L1-TC ≥1% patients in modified resected population', 'timeFrame': 'From date of randomization to 5.5 years after date of resection'}, {'measure': 'Major Pathological Response (mPR) in PD-L1-TC ≥1% patients in modified intent to treat (mITT) population', 'timeFrame': 'Up to approximately 15 weeks after randomization'}, {'measure': 'Overall Survival (OS) in PD-L1-TC ≥1% patients in modified intent to treat (mITT) population', 'timeFrame': 'From date of randomization to 5.5 years after randomization.'}, {'measure': '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', 'timeFrame': 'From date of screening to 6 months after last dose of IP', '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 durvalumab + chemotherapy prior to surgery followed by durvalumab post-surgery compared with placebo + chemotherapy prior to surgery followed by placebo post-surgery', 'timeFrame': 'From date of screening to 6 months after last dose of IP', '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', 'timeFrame': 'From date of randomization to 2 months after resection', 'description': 'To assess concentration of durvalumab in bloodstream.'}, {'measure': 'Presence of ADA for durvalumab', 'timeFrame': 'From date of randomization to 3 months after last dose of IP', 'description': 'To evaluate the presence of antibodies following treatment with study medications.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Resectable Non-small Cell Lung Cancer, NSCLC, Carcinoma, Non-small Cell Lung Cancer'], 'conditions': ['Non-Small Cell Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '40545237', 'type': 'DERIVED', 'citation': 'Mitsudomi T, Heymach JV, Reck M, Taube JM, Gao S, Horio Y, You J, Li G, Van Luong D, Saeteng S, Tanaka F, Watzka SB, Urban L, Szalai Z, Akamatsu H, Kang JH, Orlandi FJ, Mukhametshina GZ, Pircher A, Teixeira CHA, Aperghis M, Doherty GJ, Doake R, Fouad TM, Harpole D. Surgical Outcomes With Neoadjuvant Durvalumab Plus Chemotherapy Followed by Adjuvant Durvalumab in Resectable NSCLC. J Thorac Oncol. 2025 Nov;20(11):1639-1654. doi: 10.1016/j.jtho.2025.06.015. Epub 2025 Jun 20.'}, {'pmid': '37870974', 'type': 'DERIVED', 'citation': 'Heymach JV, Harpole D, Mitsudomi T, Taube JM, Galffy G, Hochmair M, Winder T, Zukov R, Garbaos G, Gao S, Kuroda H, Ostoros G, Tran TV, You J, Lee KY, Antonuzzo L, Papai-Szekely Z, Akamatsu H, Biswas B, Spira A, Crawford J, Le HT, Aperghis M, Doherty GJ, Mann H, Fouad TM, Reck M; AEGEAN Investigators. Perioperative Durvalumab for Resectable Non-Small-Cell Lung Cancer. N Engl J Med. 2023 Nov 2;389(18):1672-1684. doi: 10.1056/NEJMoa2304875. Epub 2023 Oct 23.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥18 years\n* Newly diagnosed and previously untreated patients with histologically or cytologically documented NSCLC with resectable (Stage IIA to select \\[ie, N2\\] Stage IIIB) disease\n* World Health Organization (WHO)/ECOG PS of 0 or 1 at enrollment\n* At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 Target Lesion (TL) at baseline\n* 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\n* Adequate organ and marrow function\n* Confirmation of a patient's tumour PD-L1 status\n* Provision of sufficient tumour biopsy sample for evaluation and confirmation of EGFR and ALK status\n* Planned surgery must comprise lobectomy, sleeve resection, or bilobectomy\n\nExclusion Criteria:\n\n* History of allogeneic organ transplantation\n* Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease, diverticulitis, systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome)\n* History of another primary malignancy\n* History of active primary immunodeficiency\n* Active infection including tuberculosis hepatitis B and C, or human immunodeficiency virus\n* Deemed unresectable NSCLC by multidisciplinary evaluation\n* Patients who have pre-operative radiotherapy treatment as part of their care plan\n* Patients who have brain metastases or spinal cord compression\n* Stage IIIB N3 and Stages IIIC, IVA, and IVB NSCLC\n* Known allergy or hypersensitivity to any of the study drugs or excipients\n* Existence of more than one primary tumour such as mixed small cell and NSCLC histology\n* Patients whose planned surgery at enrollment includes any of the following procedures: pneumonectomy, segmentectomies, or wedge resections\n* Patients with a documented test result confirming the presence of EGFRm or ALK translocation"}, 'identificationModule': {'nctId': 'NCT03800134', 'acronym': 'AEGEAN', 'briefTitle': 'A Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients With Resectable Non-small Cell Lung Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': 'D9106C00001'}, 'secondaryIdInfos': [{'id': '2018-002997-29', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1: Durvalumab with platinum-based chemotherapy', 'description': "Patients will receive durvalumab 1500 mg in combination with platinum-based chemotherapy every 3 weeks for up to 4 cycles prior to surgery, followed by durvalumab 1500 mg monotherapy every 4 weeks for up to 12 cycles after surgery unless disease is deemed unresectable, disease recurrence, or unacceptable toxicity\n\nThe platinum-based chemotherapy will be based on tumour histology and Investigator discretion:\n\n* cisplatin with pemetrexed\n* carboplatin with pemetrexed\n* carboplatin with paclitaxel\n* cisplatin with gemcitabine (or carboplatin with gemcitabine for patients who have comorbidities or who are unable to tolerate cisplatin per the investigator's judgment)", 'interventionNames': ['Drug: Durvalumab', 'Drug: Carboplatin', 'Drug: Cisplatin', 'Drug: Pemetrexed', 'Drug: Paclitaxel', 'Drug: Gemcitabine', 'Procedure: Surgery']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm 2: Placebo with platinum-based chemotherapy', 'description': "Patients will receive placebo in combination with platinum-based chemotherapy every 3 weeks for up to 4 cycles prior to surgery, followed by placebo monotherapy every 4 weeks for up to 12 cycles after surgery unless disease is deemed unresectable, disease recurrence, or unacceptable toxicity\n\nThe platinum-based chemotherapy will be based on tumour histology and Investigator discretion:\n\n* cisplatin with pemetrexed\n* carboplatin with pemetrexed\n* carboplatin with paclitaxel\n* cisplatin with gemcitabine (or carboplatin with gemcitabine for patients who have comorbidities or who are unable to tolerate cisplatin per the investigator's judgment)", 'interventionNames': ['Other: Placebo', 'Drug: Carboplatin', 'Drug: Cisplatin', 'Drug: Pemetrexed', 'Drug: Paclitaxel', 'Drug: Gemcitabine', 'Procedure: Surgery']}], 'interventions': [{'name': 'Durvalumab', 'type': 'DRUG', 'otherNames': ['MEDI4736'], 'description': '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', 'armGroupLabels': ['Arm 1: Durvalumab with platinum-based chemotherapy']}, {'name': 'Placebo', 'type': 'OTHER', 'description': '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', 'armGroupLabels': ['Arm 2: Placebo with platinum-based chemotherapy']}, {'name': 'Carboplatin', 'type': 'DRUG', 'description': 'Area under the curve of 5/6 on Day 1 of each 3-week cycle for 4 cycles', 'armGroupLabels': ['Arm 1: Durvalumab with platinum-based chemotherapy', 'Arm 2: Placebo with platinum-based chemotherapy']}, {'name': 'Cisplatin', 'type': 'DRUG', 'description': '75 mg/m2 on Day 1 of each 3-week cycle, for 4 cycles', 'armGroupLabels': ['Arm 1: Durvalumab with platinum-based chemotherapy', 'Arm 2: Placebo with platinum-based chemotherapy']}, {'name': 'Pemetrexed', 'type': 'DRUG', 'description': '500 mg/m2 on Day 1 of each 3-week cycle for 4 cycles.', 'armGroupLabels': ['Arm 1: Durvalumab with platinum-based chemotherapy', 'Arm 2: Placebo with platinum-based chemotherapy']}, {'name': 'Paclitaxel', 'type': 'DRUG', 'description': '200mg/m2 on Day 1 of each 3-week cycle for 4 cycles.', 'armGroupLabels': ['Arm 1: Durvalumab with platinum-based chemotherapy', 'Arm 2: Placebo with platinum-based chemotherapy']}, {'name': 'Gemcitabine', 'type': 'DRUG', 'description': '1250 mg/m2 on Day 1 and Day 8 of each 3-week cycle, for 4 cycles.', 'armGroupLabels': ['Arm 1: Durvalumab with platinum-based chemotherapy', 'Arm 2: Placebo with platinum-based chemotherapy']}, {'name': 'Surgery', 'type': 'PROCEDURE', 'description': 'Expected within 40 days from the last dose of Investigational Product following the completion of neoadjuvant treatment.', 'armGroupLabels': ['Arm 1: Durvalumab with platinum-based chemotherapy', 'Arm 2: Placebo with platinum-based chemotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85054', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '80012', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '33486', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 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