Ignite Creation Date:
2025-12-24 @ 5:15 PM
Ignite Modification Date:
2025-12-26 @ 8:24 AM
Study NCT ID:
NCT05061550
Status:
RECRUITING
Last Update Posted:
2025-12-01
First Post:
2021-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neoadjuvant and Adjuvant Treatment in Resectable Non-small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000613593', 'term': 'durvalumab'}, {'id': 'C000709515', 'term': 'monalizumab'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D000068437', 'term': 'Pemetrexed'}, {'id': 'C053518', 'term': 'CP protocol'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D006147', 'term': 'Guanine'}, {'id': 'D007042', 'term': 'Hypoxanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005971', 'term': 'Glutamates'}, {'id': 'D024342', 'term': 'Amino Acids, Acidic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000600', 'term': 'Amino Acids, Dicarboxylic'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 630}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-04-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2030-05-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-28', 'studyFirstSubmitDate': '2021-09-20', 'studyFirstSubmitQcDate': '2021-09-20', 'lastUpdatePostDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-09-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-05-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with pathological complete response (pCR)', 'timeFrame': 'From randomization to approximately 15 weeks after the first dose of study interventions'}, {'measure': 'Number of participants with adverse events (AEs) and serious adverse events (SAEs)', 'timeFrame': 'Until Day 90 after the last dose of study interventions (Up to approximately 3 years)'}], 'secondaryOutcomes': [{'measure': 'Number of participants experiencing an event-free survival (EFS) event', 'timeFrame': 'Up to approximately 3 years'}, {'measure': 'Number of participants experiencing a disease-free survival (DFS) event', 'timeFrame': 'Up to approximately 3 years'}, {'measure': 'Number of participants having surgical resection', 'timeFrame': 'From randomization to approximately 15 weeks after the first dose of study interventions'}, {'measure': 'Number of participants with major pathological response (mPR)', 'timeFrame': 'From randomization to approximately 15 weeks after the first dose of study interventions'}, {'measure': 'Number of participants with Objective response rate (ORR)', 'timeFrame': 'From randomization to approximately 15 weeks after the first dose of study interventions'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'Up to approximately 3 years'}, {'measure': 'Serum concentration of study interventions (Durvalumab/Oleclumab/Monalizumab/Volrustomig/Rilvegostomig)', 'timeFrame': 'From randomization to last dose of study interventions (Up to approximately 3 Years)'}, {'measure': 'Number of participants with anti-study drug antibodies (ADA)', 'timeFrame': 'From randomization to 3 months after last dose of study interventions (Up to approximately 3 Years)'}, {'measure': 'Baseline PD-L1 expression', 'timeFrame': 'At Screening/ baseline'}, {'measure': 'Changes in circulating tumour DNA (ctDNA)', 'timeFrame': 'From randomization to up to 24 months after last dose of study interventions (Up to approximately 3 Years)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lung Cancer', 'early-stage', 'Durvalumab', 'Oleclumab', 'Monalizumab', 'AZD0171', 'Datopotamab Deruxtecan', 'Neoadjuvant', 'Adjuvant', 'Chemotherapy', 'Volrustomig', 'Rilvegostomig'], 'conditions': ['Non-small Cell Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '40450142', 'type': 'DERIVED', 'citation': 'Cascone T, Bonanno L, Guisier F, Insa A, Liberman M, Bylicki O, Livi L, Egenod T, Corre R, Kim DW, Garcia Campelo MR, Provencio Pulla M, Shim BY, Metro G, Bennouna J, Bielska AA, Yohannes AR, He Y, Dowson A, Kar G, McGrath L, Kumar R, Grenga I, Spicer J, Forde PM. Perioperative durvalumab plus chemotherapy plus new agents for resectable non-small-cell lung cancer: the platform phase 2 NeoCOAST-2 trial. Nat Med. 2025 Aug;31(8):2788-2796. doi: 10.1038/s41591-025-03746-z. Epub 2025 May 31.'}], 'seeAlsoLinks': [{'url': 'https://www.lungcancerstudylocator.com/trial/listing/305617', 'label': 'Lung Cancer Study Locator details (for US)'}]}, 'descriptionModule': {'briefSummary': 'The study is intended to assess the safety and efficacy of perioperative treatment with Durvalumab in combination with Oleclumab, Monalizumab, or AZD0171 and platinum doublet chemotherapy (CTX); or Volrustomig or Rilvegostomig in combination with CTX; or Datopotamab deruxtecan (Dato-DXd) in combination with Durvalumab or Rilvegostomig and single agent platinum chemotherapy in participants with resectable, early-stage non-small cell lung cancer.', 'detailedDescription': 'This is an open-label, multi-arms, multicentre, randomised study, eligible participants will be enrolled and randomised to one of the following treatment regimens.\n\nArm 1: Participants will receive Oleclumab + durvalumab + CTX as neoadjuvant treatment and Oleclumab + durvalumab as adjuvant treatment.\n\nArm 2: Participants will receive Monalizumab + durvalumab + CTX as neoadjuvant treatment and Monalizumab + durvalumab as adjuvant treatment.\n\nArm 3: Participants will receive Volrustomig (Dose Exploration) + CTX as neoadjuvant treatment and Volrustomig as adjuvant treatment.\n\nArm 4: Participants will receive Dato-DXd + durvalumab + single agent platinum chemotherapy as neoadjuvant treatment and durvalumab as adjuvant treatment.\n\nArm 5: Participants will receive AZD0171 + durvalumab + CTX as neoadjuvant treatment and AZD0171 + durvalumab as adjuvant treatment.\n\nArm 6: Participants will receive Rilvegostomig + CTX as neoadjuvant treatment and Rilvegostomig as adjuvant treatment.\n\nArm 7: Participants will receive Dato-DXd + Rilvegostomig + single agent platinum chemotherapy as neoadjuvant treatment and Rilvegostomig as adjuvant treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Newly diagnosed NSCLC patients with resectable disease (Stage IIA to Stage IIIB).\n* WHO or Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Adequate organ and bone marrow function.\n* Provision of tumour samples (newly acquired or archival tumour tissue \\[≤ 6 months old\\]) to confirm Programmed death-ligand 1 (PD-L1) status, epidermal growth factor receptor (EGFR), or anaplastic lymphoma kinase (ALK) status.\n* Adequate pulmonary function.\n\nExclusion Criteria:\n\n* Participants with sensitising EGFR mutations or ALK translocations.\n* Participants with baseline PD-L1 expression status \\<1% (Arms 6 and 7 only).\n* Active or prior documented autoimmune or inflammatory disorders.\n* Uncontrolled intercurrent illness, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, active bleeding diseases, serious chronic gastrointestinal conditions associated with diarrhoea, or psychiatric illness/social situations that would limit compliance with study requirement.\n* History of another primary malignancy.\n* Participants with small-cell lung cancer or mixed small-cell lung cancer.\n* History of active primary immunodeficiency.\n* History of non-infectious interstitial lung disease (ILD) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.\n* Participants who have preoperative radiotherapy treatment as part of their care plan.\n* Participants who require or may require pneumonectomy, segmentectomies, or wedge resections, as assessed by their surgeon at baseline, to obtain potentially curative resection of primary tumour.\n* QTcF (QT interval corrected by Fridericia's formula) interval ≥ 470 ms.\n* Any medical contraindication to treatment with chemotherapy as listed in the local labelling.\n* Participants with moderate or severe cardiovascular disease.\n* Any concurrent chemotherapy, investigational product, biologic, or hormonal therapy for cancer treatment.\n* Receipt of live attenuated vaccine within 30 days prior to the first dose of study interventions.\n* Prior exposure to approved or investigational immune-mediated therapy including, but not limited to, other anti-CTLA-4, anti-TIGIT (T cell immunoreceptor with Ig and ITIM domains), anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies. Participants who received agents targeting the adenosine pathway, anti-NKG2A, anti-HLA-E agents, and anti-LIF agents are also excluded. Participants who have received previous treatment with a TROP2 targeting ADC or with another ADC containing a chemotherapy agent that inhibits TOP1 activity are also excluded.\n* Current or prior use of immunosuppressive medication within 14 days before the first dose of study interventions.\n* Active or uncontrolled infections including HBA, HBV, HCV, and HIV."}, 'identificationModule': {'nctId': 'NCT05061550', 'acronym': 'NeoCOAST-2', 'briefTitle': 'Neoadjuvant and Adjuvant Treatment in Resectable Non-small Cell Lung Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase II, Open-label, Multicentre, Randomised Study of Neoadjuvant and Adjuvant Treatment in Patients With Resectable, Early-stage (II to IIIB) Non-small Cell Lung Cancer (NeoCOAST-2)', 'orgStudyIdInfo': {'id': 'D9077C00001'}, 'secondaryIdInfos': [{'id': '2023-508852-21-00', 'type': 'REGISTRY', 'domain': 'CTIS'}, {'id': '2021-003369-37', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1: Oleclumab + Durvalumab + Platinum doublet chemotherapy (CTX)', 'description': "Participants will receive Durvalumab + Oleclumab + CTX as neoadjuvant treatment and Durvalumab + Oleclumab as adjuvant treatment.\n\nParticipants will receive one of the following chemotherapy regimens, based on the tumour histology and Investigator's discretion, as part of their treatment regimen prior to surgery:\n\nCarboplatin/Paclitaxel Pemetrexed/Cisplatin Pemetrexed/Carboplatin", 'interventionNames': ['Drug: Durvalumab', 'Drug: Oleclumab', 'Drug: Pemetrexed/Cisplatin', 'Drug: Pemetrexed/Carboplatin', 'Drug: Carboplatin/Paclitaxel']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2: Monalizumab + Durvalumab + CTX', 'description': "Participants will receive Durvalumab + Monalizumab + CTX as neoadjuvant treatment and Durvalumab + Monalizumab as adjuvant treatment.\n\nParticipants will receive one of the following chemotherapy regimens, based on the tumour histology and Investigator's discretion, as part of their treatment regimen prior to surgery:\n\nCarboplatin/Paclitaxel Pemetrexed/Cisplatin Pemetrexed/Carboplatin", 'interventionNames': ['Drug: Durvalumab', 'Drug: Monalizumab', 'Drug: Pemetrexed/Cisplatin', 'Drug: Pemetrexed/Carboplatin', 'Drug: Carboplatin/Paclitaxel']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 3: Volrustomig (Dose Exploration) + CTX', 'description': "Participants will receive Volrustomig + CTX as neoadjuvant treatment and Volrustomig as adjuvant treatment.\n\nParticipants will receive one of the following chemotherapy regimens, based on the tumour histology and Investigator's discretion, as part of their treatment regimen prior to surgery:\n\nCarboplatin/Paclitaxel Pemetrexed/Cisplatin Pemetrexed/Carboplatin", 'interventionNames': ['Drug: Pemetrexed/Cisplatin', 'Drug: Pemetrexed/Carboplatin', 'Drug: Carboplatin/Paclitaxel', 'Drug: Volrustomig']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 4: Dato-DXd + durvalumab + single agent platinum', 'description': 'Participants will receive Dato-DXd + durvalumab + single agent platinum as neoadjuvant treatment and durvalumab as adjuvant treatment.\n\nParticipants will receive one of the following chemotherapy regimens, based on physician choice of as part of their treatment regimen prior to surgery:\n\nCarboplatin or Cisplatin', 'interventionNames': ['Drug: Durvalumab', 'Drug: Dato-DXd', 'Drug: Carboplatin', 'Drug: Cisplatin']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 5: AZD0171 + durvalumab + CTX', 'description': "Participants will receive AZD0171 + durvalumab + CTX as neoadjuvant treatment and AZD0171 + durvalumab as adjuvant treatment.\n\nParticipants will receive one of the following chemotherapy regimens, based on the tumour histology and Investigator's discretion, as part of their treatment regimen prior to surgery:\n\nCarboplatin/Paclitaxel Pemetrexed/Cisplatin Pemetrexed/Carboplatin", 'interventionNames': ['Drug: Durvalumab', 'Drug: AZD0171', 'Drug: Pemetrexed/Cisplatin', 'Drug: Pemetrexed/Carboplatin', 'Drug: Carboplatin/Paclitaxel']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 6: Rilvegostomig + CTX', 'description': "Participants will receive Rilvegostomig + CTX as neoadjuvant treatment and Rilvegostomig as adjuvant treatment.\n\nParticipants will receive one of the following chemotherapy regimens, based on the tumour histology and Investigator's discretion, as part of their treatment regimen prior to surgery:\n\nCarboplatin/Paclitaxel Pemetrexed/Cisplatin Pemetrexed/Carboplatin", 'interventionNames': ['Drug: Pemetrexed/Cisplatin', 'Drug: Pemetrexed/Carboplatin', 'Drug: Carboplatin/Paclitaxel', 'Drug: Rilvegostomig']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 7: Dato-DXd + Rilvegostomig + single agent platinum', 'description': 'Participants will receive Dato-DXd + Rilvegostomig + single agent platinum as neoadjuvant treatment and Rilvegostomig as adjuvant treatment.\n\nParticipants will receive one of the following chemotherapy regimens, based on physician choice of as part of their treatment regimen prior to surgery:\n\nCarboplatin or Cisplatin', 'interventionNames': ['Drug: Dato-DXd', 'Drug: Carboplatin', 'Drug: Cisplatin', 'Drug: Rilvegostomig']}], 'interventions': [{'name': 'Durvalumab', 'type': 'DRUG', 'otherNames': ['MEDI4736, IMFINZI'], 'description': 'Participants will receive Durvalumab via intravenous route.', 'armGroupLabels': ['Arm 1: Oleclumab + Durvalumab + Platinum doublet chemotherapy (CTX)', 'Arm 2: Monalizumab + Durvalumab + CTX', 'Arm 4: Dato-DXd + durvalumab + single agent platinum', 'Arm 5: AZD0171 + durvalumab + CTX']}, {'name': 'Oleclumab', 'type': 'DRUG', 'otherNames': ['MEDI9447'], 'description': 'Participants will receive Oleclumab via intravenous route.', 'armGroupLabels': ['Arm 1: Oleclumab + Durvalumab + Platinum doublet chemotherapy (CTX)']}, {'name': 'Monalizumab', 'type': 'DRUG', 'otherNames': ['IPH2201'], 'description': 'Participants will receive Monalizumab via intravenous route.', 'armGroupLabels': ['Arm 2: Monalizumab + Durvalumab + CTX']}, {'name': 'Dato-DXd', 'type': 'DRUG', 'description': 'Participants will receive datopotamab deruxtecan (Dato-DXd) via intravenous route.', 'armGroupLabels': ['Arm 4: Dato-DXd + durvalumab + single agent platinum', 'Arm 7: Dato-DXd + Rilvegostomig + single agent platinum']}, {'name': 'AZD0171', 'type': 'DRUG', 'description': 'Participants will receive AZD0171 via intravenous route.', 'armGroupLabels': ['Arm 5: AZD0171 + durvalumab + CTX']}, {'name': 'Carboplatin', 'type': 'DRUG', 'description': 'Carboplatin as chemotherapy', 'armGroupLabels': ['Arm 4: Dato-DXd + durvalumab + single agent platinum', 'Arm 7: Dato-DXd + Rilvegostomig + single agent platinum']}, {'name': 'Cisplatin', 'type': 'DRUG', 'description': 'Cisplatin as chemotherapy', 'armGroupLabels': ['Arm 4: Dato-DXd + durvalumab + single agent platinum', 'Arm 7: Dato-DXd + Rilvegostomig + single agent platinum']}, {'name': 'Pemetrexed/Cisplatin', 'type': 'DRUG', 'description': 'Pemetrexed/Cisplatin as chemotherapy', 'armGroupLabels': ['Arm 1: Oleclumab + Durvalumab + Platinum doublet chemotherapy (CTX)', 'Arm 2: Monalizumab + Durvalumab + CTX', 'Arm 3: Volrustomig (Dose Exploration) + CTX', 'Arm 5: AZD0171 + durvalumab + CTX', 'Arm 6: Rilvegostomig + CTX']}, {'name': 'Pemetrexed/Carboplatin', 'type': 'DRUG', 'description': 'Pemetrexed/Carboplatin as chemotherapy', 'armGroupLabels': ['Arm 1: Oleclumab + Durvalumab + Platinum doublet chemotherapy (CTX)', 'Arm 2: Monalizumab + Durvalumab + CTX', 'Arm 3: Volrustomig (Dose Exploration) + CTX', 'Arm 5: AZD0171 + durvalumab + CTX', 'Arm 6: Rilvegostomig + CTX']}, {'name': 'Carboplatin/Paclitaxel', 'type': 'DRUG', 'description': 'Carboplatin/Paclitaxel, as chemotherapy', 'armGroupLabels': ['Arm 1: Oleclumab + Durvalumab + Platinum doublet chemotherapy (CTX)', 'Arm 2: Monalizumab + Durvalumab + CTX', 'Arm 3: Volrustomig (Dose Exploration) + CTX', 'Arm 5: AZD0171 + durvalumab + CTX', 'Arm 6: Rilvegostomig + CTX']}, {'name': 'Volrustomig', 'type': 'DRUG', 'otherNames': ['MEDI5752'], 'description': 'Participants will receive Volrustomig via intravenous route.', 'armGroupLabels': ['Arm 3: Volrustomig (Dose Exploration) + CTX']}, {'name': 'Rilvegostomig', 'type': 'DRUG', 'description': 'Participants will receive Rilvegostomig via intravenous route.', 'armGroupLabels': ['Arm 6: Rilvegostomig + CTX', 'Arm 7: Dato-DXd + Rilvegostomig + single agent platinum']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94611', 'city': 'Oakland', 'state': 'California', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '34994', 'city': 'Stuart', 'state': 'Florida', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 27.19755, 'lon': -80.25283}}, {'zip': '30501', 'city': 'Gainesville', 'state': 'Georgia', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.29788, 'lon': -83.82407}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 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