Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2025-12-26 @ 2:23 AM
Study NCT ID:
NCT05577702
Status:
COMPLETED
Last Update Posted:
2025-03-03
First Post:
2022-10-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy, Safety, and Pharmacodynamics of Tislelizumab Monotherapy and Multiple Tislelizumab-based Immunotherapy Combinations in Participants With 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'}], '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': 'D016190', 'term': 'Carboplatin'}, {'id': 'D000068437', 'term': 'Pemetrexed'}, {'id': 'D017239', 'term': 'Paclitaxel'}], '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'}, {'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': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 121}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-01-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-27', 'studyFirstSubmitDate': '2022-10-10', 'studyFirstSubmitQcDate': '2022-10-10', 'lastUpdatePostDateStruct': {'date': '2025-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major Pathological Response (MPR)', 'timeFrame': 'Up to approximately 18 weeks after first dose', 'description': 'MPR is defined as the proportion of participants with ≤ 10% residual viable tumor in the resected primary tumor and all resected lymph nodes as assessed by blinded independent pathology review (BIPR)'}], 'secondaryOutcomes': [{'measure': 'Pathological complete response (pCR)', 'timeFrame': 'Up to approximately 18 weeks after first dose', 'description': 'pCR is defined as the proportion of participants with absence of residual tumor in the resected primary tumor and all resected lymph nodes as assessed by the BIPR'}, {'measure': 'Event-free survival (EFS)', 'timeFrame': 'Up to approximately 2 years', 'description': 'EFS is defined as the time from randomization until any of the following events, whichever occurs first: radiographic disease progression that precludes definitive surgery, local or distant recurrence, as assessed by investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'Up to approximately 2 years', 'description': 'OS is defined as the time from the date of randomization to the date of death due to any cause'}, {'measure': 'Disease-free survival (DFS)', 'timeFrame': 'Up to approximately 2 years', 'description': 'DFS is defined as the time from the first date of no disease (ie, participants who underwent margin-negative \\[R0\\] resection) to local or distant recurrence, as assessed by the investigator according to RECIST v1.1, or death due to any cause, whichever occurs first'}, {'measure': 'Number of participants with adverse events', 'timeFrame': 'Up to approximately 2 years', 'description': 'Number of participants with treatment-emergent adverse events, including serious adverse events and immune-mediated adverse events (imAEs), with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0'}, {'measure': 'Proportion of participants who undergo surgical resection', 'timeFrame': 'Up to approximately 18 weeks after first dose', 'description': 'Proportion of participants who undergo surgical resection within a scheduled period after receiving any dose of investigational agents, delayed or canceled surgery, duration of surgery and surgical approach'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'This is a randomized, open-label, multicenter, Phase 2, umbrella study to evaluate the preliminary efficacy, safety, and pharmacodynamics of tislelizumab as monotherapy and in combination with investigational agents as neoadjuvant treatment in Chinese participants with resectable Stage II to IIIA non-small cell lung cancer (NSCLC). The study is designed with the flexibility of adding treatment arms as new treatments become available or discontinuing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, and of modifying the participant population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1\n* Histologically confirmed Stage II-IIIA NSCLC (per the Eighth American Joint Committee on Cancer/Union Internationale Contre le Cancer \\[NSCLC\\] staging system)\n* Evaluation by an attending thoracic surgeon to confirm eligibility for an R0 resection with curative intent\n* Adequate hematologic and organ function, defined by protocol-specified laboratory test results, obtained ≤ 7 days before randomization\n* Provide formalin-fixed paraffin-embedded block (preferred) or at least 15 freshly cut unstained FFPE slides of the primary tumor for biomarker evaluation during screening\n\nExclusion Criteria:\n\n* Any prior antineoplastic therapy(ies) for current lung cancer (eg, radiotherapy, targeted therapies, ablation, or other systemic or local antineoplastic treatment)\n* Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, anti-cell immunoglobulin and ITIM domain (TIGIT), anti-lymphocyte activation gene-3 (LAG-3), or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways\n* Has mixed small cell lung cancer\n* Participants with large cell neuroendocrine carcinoma (LCNEC)\n* The presence of locally advanced unresectable NSCLC regardless of stage or metastatic disease\n* Known EGFR sensitizing mutations and/or ALK rearrangement\n\nNOTE: Other protocol defined Inclusion/Exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT05577702', 'briefTitle': 'Efficacy, Safety, and Pharmacodynamics of Tislelizumab Monotherapy and Multiple Tislelizumab-based Immunotherapy Combinations in Participants With Resectable Non-Small Cell Lung Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'BeiGene'}, 'officialTitle': 'A Randomized, Open-Label, Multicenter, Phase 2, Umbrella Study to Evaluate the Preliminary Efficacy, Safety, and Pharmacodynamics of Tislelizumab Monotherapy and Multiple Tislelizumab-based Immunotherapy Combinations With and Without Chemotherapy as Neoadjuvant Treatment in Chinese Patients With Resectable Stage II to IIIA Non-Small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'BGB-LC-202'}, 'secondaryIdInfos': [{'id': 'CTR20222760', 'type': 'OTHER', 'domain': 'ChinaDrugTrials'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1A: Tislelizumab Monotherapy', 'description': 'Tislelizumab on a 3-week cycle for 2 to 4 cycles, followed by surgical resection (each cycle is 21 days)', 'interventionNames': ['Drug: Tislelizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 1B: Tislelizumab and Ociperlimab', 'description': 'Tislelizumab + ociperlimab on a 3-week cycle for 2 to 4 cycles, followed by surgical resection (each cycle is 21 days)', 'interventionNames': ['Drug: Tislelizumab', 'Drug: Ociperlimab']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 1C: Tislelizumab and LBL-007', 'description': 'Tislelizumab + LBL-007 on a 3-week cycle for 2 to 4 cycles, followed by surgical resection (each cycle is 21 days)', 'interventionNames': ['Drug: Tislelizumab', 'Drug: LBL-007']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2A: Tislelizumab and Chemotherapy', 'description': 'Tislelizumab + chemotherapy on a 3-week cycle for 2 to 4 cycles, followed by surgical resection (each cycle is 21 days); Platinum-based doublet chemotherapy options may include:\n\n* Cisplatin/carboplatin + pemetrexed (nonsquamous)\n* Cisplatin/carboplatin + paclitaxel (squamous)', 'interventionNames': ['Drug: Tislelizumab', 'Drug: Cisplatin', 'Drug: Carboplatin', 'Drug: Pemetrexed', 'Drug: Paclitaxel']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2C: LBL-007 and Tislelizumab and Chemotherapy', 'description': 'LBL-007 + tislelizumab + chemotherapy on a 3-week cycle for 2 to 4 cycles, followed by surgical resection (each cycle is 21 days); Platinum-based doublet chemotherapy options may include:\n\n* Cisplatin/carboplatin + pemetrexed (nonsquamous)\n* Cisplatin/carboplatin + paclitaxel (squamous)', 'interventionNames': ['Drug: Tislelizumab', 'Drug: LBL-007', 'Drug: Cisplatin', 'Drug: Carboplatin', 'Drug: Pemetrexed', 'Drug: Paclitaxel']}], 'interventions': [{'name': 'Tislelizumab', 'type': 'DRUG', 'otherNames': ['BGB-A317', 'Tevimbra'], 'description': 'Administered as an intravenous infusion', 'armGroupLabels': ['Arm 1A: Tislelizumab Monotherapy', 'Arm 1B: Tislelizumab and Ociperlimab', 'Arm 1C: Tislelizumab and LBL-007', 'Arm 2A: Tislelizumab and Chemotherapy', 'Arm 2C: LBL-007 and Tislelizumab and Chemotherapy']}, {'name': 'Ociperlimab', 'type': 'DRUG', 'otherNames': ['BGB-A1217'], 'description': 'Administered as an intravenous infusion', 'armGroupLabels': ['Arm 1B: Tislelizumab and Ociperlimab']}, {'name': 'LBL-007', 'type': 'DRUG', 'description': 'Administered as an intravenous infusion', 'armGroupLabels': ['Arm 1C: Tislelizumab and LBL-007', 'Arm 2C: LBL-007 and Tislelizumab and Chemotherapy']}, {'name': 'Cisplatin', 'type': 'DRUG', 'description': 'Administered as an intravenous infusion', 'armGroupLabels': ['Arm 2A: Tislelizumab and Chemotherapy', 'Arm 2C: LBL-007 and Tislelizumab and Chemotherapy']}, {'name': 'Carboplatin', 'type': 'DRUG', 'description': 'Administered as an intravenous infusion', 'armGroupLabels': ['Arm 2A: Tislelizumab and Chemotherapy', 'Arm 2C: LBL-007 and Tislelizumab and Chemotherapy']}, {'name': 'Pemetrexed', 'type': 'DRUG', 'description': 'Administered as an intravenous infusion', 'armGroupLabels': ['Arm 2A: Tislelizumab and Chemotherapy', 'Arm 2C: LBL-007 and Tislelizumab and Chemotherapy']}, {'name': 'Paclitaxel', 'type': 'DRUG', 'description': 'Administered as an intravenous infusion', 'armGroupLabels': ['Arm 2A: Tislelizumab and Chemotherapy', 'Arm 2C: LBL-007 and Tislelizumab and Chemotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '241001', 'city': 'Wuhu', 'state': 'Anhui', 'country': 'China', 'facility': 'The First Affiliated Hospital of Wannan Medical College', 'geoPoint': {'lat': 31.35259, 'lon': 118.42947}}, {'zip': '100142', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Cancer Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '350001', 'city': 'Fuzhou', 'state': 'Fujian', 'country': 'China', 'facility': 'Fujian Medical University Union Hospital', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}, {'zip': '510140', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'The First Affiliated Hospital of Guangzhou Medical Universitydatansha Hospital)', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '530021', 'city': 'Nanning', 'state': 'Guangxi', 'country': 'China', 'facility': 'The Tumor Hospital Affiliated to Guangxi Medical University', 'geoPoint': {'lat': 22.81667, 'lon': 108.31667}}, {'zip': '455001', 'city': 'Anyang', 'state': 'Henan', 'country': 'China', 'facility': 'Anyang Cancer Hospital', 'geoPoint': {'lat': 36.096, 'lon': 114.38278}}, {'zip': '430079', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Hubei Cancer Hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '410013', 'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'facility': 'Hunan Cancer Hospital', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'zip': '332000', 'city': 'Nanchang', 'state': 'Jiangxi', 'country': 'China', 'facility': 'The First Affiliated Hospital of Nanchang University Branch Xianghu', 'geoPoint': {'lat': 28.68396, 'lon': 115.85306}}, {'zip': '110042', 'city': 'Shenyang', 'state': 'Liaoning', 'country': 'China', 'facility': 'Liaoning Cancer Hospital and Institute', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'zip': '250117', 'city': 'Jinan', 'state': 'Shandong', 'country': 'China', 'facility': 'Shandong Cancer Hospital', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'zip': '200025', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Rui Jin Hospital Shanghai Jiao Tong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200433', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai Pulmonary Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '315000', 'city': 'Ningbo', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Hwa Mei Hospital, University of Chinese Academy of Sciences (Ningbo No Hospital)', 'geoPoint': {'lat': 29.87819, 'lon': 121.54945}}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'BeiGene'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BeiGene', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}