Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2025-12-29 @ 2:33 AM
Study NCT ID:
NCT04379635
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-21
First Post:
2020-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing the Efficacy and Safety of a New Additional Treatment With Tislelizumab in Non-Small Cell Lung Cancer (NSCLC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'C000707970', 'term': 'tislelizumab'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D000068437', 'term': 'Pemetrexed'}, {'id': 'D016190', 'term': 'Carboplatin'}], 'ancestors': [{'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'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'}, {'id': 'D056831', 'term': 'Coordination Complexes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 453}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-05-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2020-05-04', 'studyFirstSubmitQcDate': '2020-05-05', 'lastUpdatePostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-05-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major pathological response (MPR) in Intent-to-Treat (ITT) analysis set', 'timeFrame': 'Up to 3 months following completion of neoadjuvant treatment'}, {'measure': 'Event-free survival (EFS) in ITT analysis set as Assessed by the Blinded Independent Central Review (BICR)', 'timeFrame': 'Up to 5 years'}], 'secondaryOutcomes': [{'measure': 'Overall survival (OS) in the ITT set', 'timeFrame': 'Up to 5 years'}, {'measure': 'Pathological complete response (pCR) rate', 'timeFrame': 'Up to 5 years'}, {'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'Up to 5 years'}, {'measure': 'Disease-Free Survival (DFS) in ITT analysis set', 'timeFrame': 'Up to 5 years'}, {'measure': 'Event-free survival (EFS) Assessed by the Investigator', 'timeFrame': 'Up to 5 years'}, {'measure': 'Number of participants experiencing treatment-emergent adverse events (TEAEs)', 'timeFrame': 'Up to 5 years'}, {'measure': 'Efficacy and Safety as Assessed by Health-related quality of life (HRQoL) Questionnaire', 'timeFrame': 'Up to 5 years'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non Small Cell Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '41344593', 'type': 'DERIVED', 'citation': 'Wang C, Wang W, Liu H, Chen Q, Chen C, Liu L, Zhang P, Zhao G, Yang F, Han G, Yu B, Yang Y, Chen H, Jiang J, Tan L, Xu S, Mao N, Hu J, Zhang L, Zhang Z, Yao B, Wang S, Leaw S, Naicker K, Zheng W, Yu C, Yue D; RATIONALE-315 investigators. Peri-operative tislelizumab plus neoadjuvant chemotherapy for patients with resectable non-small cell lung cancer: final analysis of the randomized RATIONALE-315 trial. Ann Oncol. 2025 Dec 2:S0923-7534(25)06287-8. doi: 10.1016/j.annonc.2025.11.017. Online ahead of print.'}, {'pmid': '39581197', 'type': 'DERIVED', 'citation': 'Yue D, Wang W, Liu H, Chen Q, Chen C, Liu L, Zhang P, Zhao G, Yang F, Han G, Cheng Y, Yu B, Yang Y, Chen H, Jiang J, Tan L, Xu S, Mao N, Hu J, Zhang L, Yao B, Wang S, Wang RH, Zheng W, Wang C; RATIONALE-315 investigators. Perioperative tislelizumab plus neoadjuvant chemotherapy for patients with resectable non-small-cell lung cancer (RATIONALE-315): an interim analysis of a randomised clinical trial. Lancet Respir Med. 2025 Feb;13(2):119-129. doi: 10.1016/S2213-2600(24)00269-8. Epub 2024 Nov 21.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to evaluate and compare major pathological response(MPR) rate and event-free survival (EFS) in participants receiving tislelizumab plus platinum-based doublet chemotherapy as the new additional treatment followed by tislelizumab as adjuvant treatment versus participants receiving placebo plus platinum-based doublet chemotherapy as neoadjuvant treatment followed by placebo as adjuvant treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n1. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1\n2. Histologically confirmed Stage II or IIIA NSCLC\n3. Measurable disease as assessed per RECIST v1.1\n4. Confirm eligibility for an R0 resection with curative intent\n\nKey Exclusion Criteria:\n\n1. Any prior therapy for current lung cancer, including chemotherapy, or radiotherapy\n2. Known Epidermal growth factor receptor (EGFR) mutation or Anaplastic Lymphoma Kinase (ALK) gene translocation\n3. Any condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days before randomization\n4. Active autoimmune diseases or history of autoimmune diseases that may relapse\n5. History of interstitial lung disease, non-infectious pneumonitis or uncontrolled diseases including pulmonary fibrosis, acute lung diseases, etc.\n\nNOTE: Other protocol defined Inclusion/Exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT04379635', 'briefTitle': 'Comparing the Efficacy and Safety of a New Additional Treatment With Tislelizumab in Non-Small Cell Lung Cancer (NSCLC)', 'organization': {'class': 'INDUSTRY', 'fullName': 'BeOne Medicines'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Compare the Efficacy and Safety of Neoadjuvant Treatment With Tislelizumab (BGB-A317, Anti-PD-1 Antibody) or Placebo Plus Platinum-Based Doublet Chemotherapy Followed By Adjuvant Tislelizumab or Placebo in Resectable Stage II or IIIA Non-Small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'BGB-A317-315'}, 'secondaryIdInfos': [{'id': 'CTR20200821', 'type': 'REGISTRY', 'domain': 'ChinaDrugTrials'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Neoadjuvant chemotherapy + Neoadjuvant/Adjuvant Tislelizumab', 'description': 'Tislelizumab + cisplatin/carboplatin + paclitaxel or Pemetrexed Disodium', 'interventionNames': ['Drug: Tislelizumab', 'Drug: Cisplatin injection', 'Drug: Paclitaxel injection', 'Drug: Pemetrexed Disodium', 'Drug: Carboplatin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Neoadjuvant chemotherapy + Neoadjuvant/Adjuvant Placebo', 'description': 'Placebo + cisplatin/carboplatin + paclitaxel or Pemetrexed Disodium', 'interventionNames': ['Drug: Cisplatin injection', 'Drug: Paclitaxel injection', 'Drug: Pemetrexed Disodium', 'Drug: Placebos', 'Drug: Carboplatin']}], 'interventions': [{'name': 'Tislelizumab', 'type': 'DRUG', 'otherNames': ['BGB-A317'], 'description': 'administered via Intravenous (IV) injection', 'armGroupLabels': ['Neoadjuvant chemotherapy + Neoadjuvant/Adjuvant Tislelizumab']}, {'name': 'Cisplatin injection', 'type': 'DRUG', 'description': 'administered via IV infusion', 'armGroupLabels': ['Neoadjuvant chemotherapy + Neoadjuvant/Adjuvant Placebo', 'Neoadjuvant chemotherapy + Neoadjuvant/Adjuvant Tislelizumab']}, {'name': 'Paclitaxel injection', 'type': 'DRUG', 'description': 'administered via IV infusion', 'armGroupLabels': ['Neoadjuvant chemotherapy + Neoadjuvant/Adjuvant Placebo', 'Neoadjuvant chemotherapy + Neoadjuvant/Adjuvant Tislelizumab']}, {'name': 'Pemetrexed Disodium', 'type': 'DRUG', 'description': 'administered via IV infusion', 'armGroupLabels': ['Neoadjuvant chemotherapy + Neoadjuvant/Adjuvant Placebo', 'Neoadjuvant chemotherapy + Neoadjuvant/Adjuvant Tislelizumab']}, {'name': 'Placebos', 'type': 'DRUG', 'description': 'Placebo to match tislelizumab IV infusion', 'armGroupLabels': ['Neoadjuvant chemotherapy + Neoadjuvant/Adjuvant Placebo']}, {'name': 'Carboplatin', 'type': 'DRUG', 'description': 'administered via IV infusion', 'armGroupLabels': ['Neoadjuvant chemotherapy + Neoadjuvant/Adjuvant Placebo', 'Neoadjuvant chemotherapy + Neoadjuvant/Adjuvant Tislelizumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '230000', 'city': 'Hefei', 'state': 'Anhui', 'country': 'China', 'facility': 'Anhui Provincial Hospital', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'zip': '100044', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Peking University Peoples Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100050', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Friendship Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100053', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Xuanwu Hospital Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100142', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Cancer Hospital', 'geoPoint': 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dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved.\n\nBeiGene shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations.\n\nQualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeiGene review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.', 'accessCriteria': 'See plan description'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BeiGene', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}