Ignite Creation Date:
2025-12-24 @ 2:46 PM
Ignite Modification Date:
2026-02-22 @ 6:46 PM
Study NCT ID:
NCT06624059
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-22
First Post:
2024-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to See How Well and How Safely Different Treatments Work in a Group of Participants With Non-Small Cell Lung Cancer (NSCLC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Poland']}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung 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': 'C582670', 'term': 'alectinib'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D000068437', 'term': 'Pemetrexed'}], 'ancestors': [{'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-11-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2033-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-21', 'studyFirstSubmitDate': '2024-10-01', 'studyFirstSubmitQcDate': '2024-10-01', 'lastUpdatePostDateStruct': {'date': '2025-10-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-10-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-06-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cohort B1: Incidence, type, and severity of adverse events (AEs) with onset up to 28 days after the last dose of chemotherapy', 'timeFrame': 'Up to 28 days after the last dose of chemotherapy treatment (up to 4 cycles, cycle length = 3 weeks)'}, {'measure': 'Cohort B2: Investigator-assessed pathologic complete response (inv-pCR)', 'timeFrame': 'At the time of surgical resection (approximately weeks 14-17)'}], 'secondaryOutcomes': [{'measure': 'Cohort B1: Investigator-assessed disease-free survival (DFS)', 'timeFrame': 'From initiation of study treatment to the first documented recurrence of disease or new primary NSCLC or death from any cause, whichever occurs first (up to approximately 5 years)'}, {'measure': 'Cohort B1: Overall survival (OS)', 'timeFrame': 'From initiation of study treatment to death from any cause (up to approximately 8 years)'}, {'measure': 'Cohort B1: Incidence, type, and severity of AEs with onset up to 28 days after the last dose of study treatment', 'timeFrame': 'From first dose to up to approximately 5 years'}, {'measure': 'Cohort B1: Time to first onset of selected AEs', 'timeFrame': 'From first dose to up to approximately 5 years'}, {'measure': 'Cohort B1: Change from baseline in target safety parameters', 'timeFrame': 'From first dose to up to approximately 5 years'}, {'measure': 'Cohort B2: Investigator-assessed major pathological response (inv-MPR)', 'timeFrame': 'At the time of surgical resection (approximately weeks 14-17)'}, {'measure': 'Cohort B2: Pathologic complete response (pCR) by independent review', 'timeFrame': 'At the time of surgical resection (approximately weeks 14-17)'}, {'measure': 'Cohort B2: Major pathologic response (MPR) by independent review', 'timeFrame': 'At the time of surgical resection (approximately weeks 14-17)'}, {'measure': 'Cohort B2: Investigator-assessed overall response rate (ORR)', 'timeFrame': 'Up to approximately Week 17'}, {'measure': 'Cohort B2: Investigator-assessed event-free survival (EFS)', 'timeFrame': 'From first treatment to the first documented disease progression that prevents surgery, local or distant disease recurrence, or death from any cause (up to approximately 5 years)'}, {'measure': 'Cohort B2: Overall Survival (OS)', 'timeFrame': 'From initiation of study treatment to death from any cause (up to approximately 8 years)'}, {'measure': 'Cohort B2: Incidence, severity, and type of AEs', 'timeFrame': 'From first dose up to approximately 5 years'}, {'measure': 'Cohort B2: Change from baseline in target safety parameters', 'timeFrame': 'From first dose to up to approximately 5 years'}, {'measure': 'Cohort B2: Frequency of surgery completion, defined as participants who have successfully completed surgery without treatment-related delays (> 60 days) from the last dose of neoadjuvant treatment', 'timeFrame': 'At the time of surgical resection (approximately weeks 14-17)'}, {'measure': 'Cohort B2: Length of treatment-related surgical delays, incidence of operative and post-operative complications, and/or reasons for surgical cancellations', 'timeFrame': 'Approximately weeks 14-24'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non-Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the efficacy and/or safety of multiple therapies in patients with early-stage resectable NSCLC. Cohort B1 is a phase II cohort that will evaluate the safety, and efficacy of alectinib in combination with up to four cycles of platinum-based chemotherapy in the adjuvant setting post complete surgical resection. Cohort B2 is a phase II cohort that will evaluate the efficacy and safety of perioperative alectinib in combination with chemotherapy in the neoadjuvant setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria Cohort B1:\n\n* Complete resection of the primary NSCLC with negative margins\n* Confirmed stage II to select stage IIIB (T3N2) NSCLC of non-squamous (adenocarcinoma) histology\n* Eastern cooperative oncology group (ECOG) performance status of 0 or 1\n\nInclusion Criteria Cohort B2:\n\n* Evaluation by the operating attending surgeon and involved medical oncologist prior to study enrollment to verify study eligibility for complete surgical resection with curative intent\n* Pathologically and/or histologically confirmed Stage II-IIIA and IIIB (T3N2 only) NSCLC of non-squamous (adenocarcinoma) histology\n\nInclusion Criteria Cohorts B1 and B2:\n\n* Documented ALK fusion\n\nExclusion Criteria Cohort B1:\n\n* NSCLC of squamous or mixed histology regardless of the presence of an ALK mutation\n* Prior exposure to any systemic anti-cancer therapy\n\nExclusion Criteria Cohort B2:\n\n* NSCLC of squamous or mixed histology regardless of the presence of an ALK mutation\n* Known sensitivity to any component of alectinib, pemetrexed, cisplatin, or carboplatin\n* Prior exposure to any systemic anti-cancer therapy\n\nExclusion Criteria Cohorts B1 and B2:\n\n* Pregnancy or breastfeeding, or intention of becoming pregnant during the study'}, 'identificationModule': {'nctId': 'NCT06624059', 'acronym': 'HORIZON 2', 'briefTitle': 'A Study to See How Well and How Safely Different Treatments Work in a Group of Participants With Non-Small Cell Lung Cancer (NSCLC)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Phase I-III, Multicenter Study Evaluating the Efficacy and Safety of Multiple Therapies in Cohorts of Patients With Resectable Stage I-III Non-Small Cell Lung Cancer, Selected According to Biomarker Status', 'orgStudyIdInfo': {'id': 'BO43249'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort B1', 'description': 'Participants will receive alectinib in combination with platinum-based chemotherapy for up to 4 cycles (cycle length = 3 weeks), followed by alectinib monotherapy for up to 5 years.', 'interventionNames': ['Drug: Alectinib', 'Drug: Cisplatin', 'Drug: Carboplatin', 'Drug: Pemetrexed']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort B2', 'description': 'Participants will receive alectinib and platinum-based chemotherapy for up to 3 cycles (cycle length = 3 weeks) prior to surgery, and alectinib monotherapy after surgery for up to 5 years after surgery.', 'interventionNames': ['Drug: Alectinib', 'Drug: Cisplatin', 'Drug: Carboplatin', 'Drug: Pemetrexed']}], 'interventions': [{'name': 'Alectinib', 'type': 'DRUG', 'description': 'Cohort B1: participants will receive oral alectinib twice daily (BID) for up to 5 years.\n\nCohort B2: Participants will receive oral alectinib BID for 3 cycles (cycle length = 3 weeks) prior to surgery, and for up to 5 years after surgery.', 'armGroupLabels': ['Cohort B1', 'Cohort B2']}, {'name': 'Cisplatin', 'type': 'DRUG', 'description': 'Cohort B1: Participants will receive intravenous (IV) cisplatin on Day 1 of each cycle for up to 4 cycles (cycle length = 3 weeks).\n\nCohort B2: Participants will receive IV cisplatin on Day 1 of each cycle for up to 3 cycles (cycles length = 3 weeks) prior to surgery.', 'armGroupLabels': ['Cohort B1', 'Cohort B2']}, {'name': 'Carboplatin', 'type': 'DRUG', 'description': 'Cohort B1: Participants will receive IV carboplatin on Day 1 of each cycle for up to 4 cycles (cycle length = 3 weeks).\n\nCohort B2: Participants will receive IV carboplatin on Day 1 of each cycle for up to 3 cycles (cycle length = 3 weeks) prior to surgery.', 'armGroupLabels': ['Cohort B1', 'Cohort B2']}, {'name': 'Pemetrexed', 'type': 'DRUG', 'description': 'Cohort B1: Participants will receive IV pemetrexed on Day 1 of each cycle for up to 4 cycles (cycle length = 3 weeks).\n\nCohort B2: Participants will receive IV pemetrexed on Day 1 of each cycle for up to 3 cycles (cycle length = 3 weeks) prior to surgery.', 'armGroupLabels': ['Cohort B1', 'Cohort B2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Anschutz Medical Campus', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '11590', 'city': 'Westbury', 'state': 'New York', 'country': 'United States', 'facility': 'Clinical Research Alliance', 'geoPoint': {'lat': 40.75566, 'lon': -73.58763}}, {'zip': '38120', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Baptist Cancer Center', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '2065', 'city': 'St Leonards', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Royal North Shore Hospital', 'geoPoint': {'lat': -33.82344, 'lon': 151.19836}}, {'zip': '6009', 'city': 'Nedlands', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Sir Charles Gairdner Hospital', 'geoPoint': {'lat': -31.98184, 'lon': 115.8073}}, {'zip': '95070-560', 'city': 'Caxias do Sul', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Universidade de Caxias do Sul - Rio Grande do Sul', 'geoPoint': {'lat': -29.16806, 'lon': -51.17944}}, {'zip': '90035-903', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Hospital de Clínicas de Porto Alegre X', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '90610-000', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Hospital Sao Lucas - PUCRS', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '14784-400', 'city': 'Barretos', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital de Cancer de Barretos', 'geoPoint': {'lat': -20.55722, 'lon': -48.56778}}, {'zip': '15090-000', 'city': 'São José do Rio Preto', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital de Base de Sao Jose do Rio Preto', 'geoPoint': {'lat': -20.81972, 'lon': -49.37944}}, {'zip': '01246-000', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Instituto do Cancer do Estado de Sao Paulo - ICESP', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'Santiago', 'country': 'Chile', 'facility': 'RedSalud Vitacura', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'zip': '100142', 'city': 'Beijing', 'country': 'China', 'facility': 'Beijing Cancer Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '410008', 'city': 'Changsha', 'country': 'China', 'facility': 'Xiangya Hospital of Centre-South University', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'city': 'Chengdu', 'country': 'China', 'facility': "The third people's hospital of Chengdu", 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '510000', 'city': 'Guangzhou', 'country': 'China', 'facility': 'Guangdong General Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Jinhua', 'country': 'China', 'facility': 'Jinhua municipal central hospital', 'geoPoint': {'lat': 29.10678, 'lon': 119.64421}}, {'zip': '650118', 'city': 'Kunming', 'country': 'China', 'facility': 'Yunnan Cancer Hospital', 'geoPoint': {'lat': 25.03889, 'lon': 102.71833}}, {'zip': '430030', 'city': 'Wuhan', 'country': 'China', 'facility': 'Tongji Hospital Tongji Medical College Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '69008', 'city': 'Lyon', 'country': 'France', 'facility': 'Centre Leon Berard', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '13005', 'city': 'Marseille', 'country': 'France', 'facility': 'CHU Timone', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '33600', 'city': 'Pessac', 'country': 'France', 'facility': 'CHU de Bordeaux', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}, {'zip': '67091', 'city': 'Strasbourg', 'country': 'France', 'facility': 'CHU Strasbourg - Nouvel Hopital Civil', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '06156', 'city': 'Perugia', 'state': 'Umbria', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia', 'geoPoint': {'lat': 43.1122, 'lon': 12.38878}}, {'zip': '04700', 'city': 'Mexico City', 'state': 'Mexico CITY (federal District)', 'country': 'Mexico', 'facility': 'Centro Oncologico Internacional', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'zip': '06700', 'city': 'Mexico City', 'country': 'Mexico', 'facility': 'ARKE Estudios Clínicos S.A. de C.V.', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'zip': '1023', 'city': 'Auckland', 'country': 'New Zealand', 'facility': 'Auckland City Hospital, Cancer and Blood Research', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}, {'zip': '16247', 'city': 'Gyeonggi-do', 'country': 'South Korea', 'facility': "St. Vincent's Hospital", 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'zip': '03722', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Severance Hospital, Yonsei University Health System', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '05505', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06351', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': "Hospital Universitari Vall d'Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '29010', 'city': 'Málaga', 'country': 'Spain', 'facility': 'Hospital Regional Universitario Carlos Haya', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'zip': '10700', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Faculty of Med. Siriraj Hosp.', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'zip': '50200', 'city': 'Chang Mai', 'country': 'Thailand', 'facility': 'Maharaj Nakorn Chiang Mai Hosp'}, {'zip': '10300', 'city': 'Dusit', 'country': 'Thailand', 'facility': 'Oncology Unit, Faculty of Medicine, Vajira Hospital', 'geoPoint': {'lat': 13.7775, 'lon': 100.51977}}, {'zip': '40002', 'city': 'Khon Kaen', 'country': 'Thailand', 'facility': 'Srinagarind Hospital', 'geoPoint': {'lat': 16.44671, 'lon': 102.833}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\\_sharing"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}