Ignite Creation Date:
2025-12-24 @ 11:31 PM
Ignite Modification Date:
2026-01-01 @ 5:03 PM
Study NCT ID:
NCT05920356
Status:
RECRUITING
Last Update Posted:
2025-12-12
First Post:
2023-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'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': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000706028', 'term': 'sotorasib'}, {'id': 'C582435', 'term': 'pembrolizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 750}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-16', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2031-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-10', 'studyFirstSubmitDate': '2023-05-23', 'studyFirstSubmitQcDate': '2023-06-26', 'lastUpdatePostDateStruct': {'date': '2025-12-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free Survival (PFS)', 'timeFrame': 'Approximately 2.5 years', 'description': 'PFS is defined as the time from randomization until the first documentation of radiologic disease progression or death due to any cause, whichever occurs first. Progression will be based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, per Blinded Independent Central Review (BICR).'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Approximately 2.5 years', 'description': 'OS is defined as the time from randomization until death due to any cause.'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'From Baseline up to end of study (EOS) (approximately 5.5 years)', 'description': 'Objective response is defined as the best overall response of complete response (CR) or partial response (PR), based on RECIST v1.1, per BICR.'}, {'measure': 'Change in Quality-of-Life Questionnaire Core 30 (QLQ-C30) Dyspnea Domain Score', 'timeFrame': 'From Baseline to Week 12'}, {'measure': 'Change in Quality-of-Life Questionnaire Lung Cancer 13 (QLQ-LC13) Symptoms of Dyspnea Subscale', 'timeFrame': 'From Baseline to Week 12'}, {'measure': 'Change in QLQ-LC13 Symptoms of Cough Subscale', 'timeFrame': 'From Baseline to Week 12'}, {'measure': 'Change in QLQ-LC13 Symptoms of Chest Pain Subscale', 'timeFrame': 'From Baseline to Week 12'}, {'measure': 'Change in Physical Function as Measured by QLQ-C30', 'timeFrame': 'From Baseline to Week 12'}, {'measure': 'Change in Global Health Status as Measured by QLQ-C30', 'timeFrame': 'From Baseline to Week 12'}, {'measure': 'Progression-free Survival 2 (PFS2)', 'timeFrame': 'From Baseline up to EOS (approximately 5.5 years)', 'description': 'PFS2 is defined as the time from randomization to progression per investigator after initiation of new anticancer therapy or death from any cause, whichever occurs first.'}, {'measure': 'Change in QLQ-LC13 Subscale Scores', 'timeFrame': 'From Baseline up to EOS (approximately 5.5 years)'}, {'measure': 'Change in QLQ-C30 Subscale Scores', 'timeFrame': 'From Baseline up to EOS (approximately 5.5 years)'}, {'measure': 'Time to Deterioration in QLC-LC13 Subscale Scores', 'timeFrame': 'From Baseline to Week 12'}, {'measure': 'Time to Deterioration in QLC-C30 Subscale Scores', 'timeFrame': 'From Baseline to Week 12'}, {'measure': 'Change in Summary Scores and Visual Analogue Scale (VAS) Scores', 'timeFrame': 'From Baseline up to EOS (approximately 5.5 years)', 'description': 'Measured by EuroQol-5 Dimension (EQ-5D-5L).'}, {'measure': 'Duration of Response', 'timeFrame': 'From Baseline up to EOS (approximately 5.5 years)', 'description': 'Duration of response is defined as the time from the first documentation of objective response until the first documentation of disease progression per BICR or death due to any cause, whichever occurs first.'}, {'measure': 'Time to Response', 'timeFrame': 'From Baseline up to EOS (approximately 5.5 years)', 'description': 'Defined as the time from randomization to first evidence of PR or CR per BICR.'}, {'measure': 'Disease Control', 'timeFrame': 'From Baseline up to EOS (approximately 5.5 years)', 'description': 'Defined as CR plus PR plus stable disease based on RECIST v1.1 per BICR.'}, {'measure': 'PFS', 'timeFrame': 'From Baseline up to EOS (approximately 5.5 years)', 'description': 'Based on investigator tumor assessments per RECIST v1.1.'}, {'measure': 'Objective Response', 'timeFrame': 'From Baseline up to EOS (approximately 5.5 years)', 'description': 'Based on investigator tumor assessments per RECIST v1.1.'}, {'measure': 'Number of Participants With Treatment-Emergent Adverse Events', 'timeFrame': 'From Baseline up to EOS (approximately 5.5 years)'}, {'measure': 'Number of Participants With Clinically Significant Changes in Vital Signs', 'timeFrame': 'From Baseline up to EOS (approximately 5.5 years)'}, {'measure': 'Number of Participants With Clinically Significant Changes in Clinical Laboratory Tests', 'timeFrame': 'From Baseline up to EOS (approximately 5.5 years)'}, {'measure': 'Maximum Plasma Concentration (Cmax) of Sotorasib', 'timeFrame': 'Pre-dose Day 1 up to Day 64'}, {'measure': 'Minimum Plasma Concentration (Cmin) of Sotorasib', 'timeFrame': 'Pre-dose Day 1 up to Day 64'}, {'measure': 'Area Under The Curve (AUC) of Sotorasib', 'timeFrame': 'Pre-dose Day 1 up to Day 64'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Oncology', 'Lung Cancer', 'PD-L1', 'KRAS p.G12C', 'Sotorasib', 'Pembrolizumab', 'Carboplatin', 'Pemetrexed', 'CodeBreaK 202', 'NSCLC', 'PD-L1 Negative', 'AMG 510', 'LUMAKRAS ®', 'LUMYKRAS ®'], 'conditions': ['Non-Small Cell Lung Cancer (NSCLC)']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}]}, 'descriptionModule': {'briefSummary': 'The primary objectives are to compare progression-free survival (PFS) and overall survival (OS) in participants who receive sotorasib with platinum doublet chemotherapy versus participants who receive pembrolizumab with platinum doublet chemotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically confirmed diagnosis of nonsquamous stage IV or advanced Stage IIIB or IIIC NSCLC with KRAS p. G12C mutation and negative for PD-L1 expression by central testing or local laboratory testing confirmed through central testing\n* No history of systemic anticancer therapy in metastatic/non-curable settings\n* Eastern Cooperative Oncology Group (ECOG) ≤ 1\n\nExclusion Criteria:\n\n* Mixed histology NSCLC with either small-cell or large-cell neuroendocrine cell component or predominant squamous cell histology\n* Participants with tumors known to harbor molecular alterations for which targeted therapy is locally approved as a front-line therapy\n* Symptomatic (treated or untreated) brain metastases\n* Gastrointestinal (GI) tract disease causing the inability to take oral medication\n* Myocardial infarction within 6 months of randomization, unstable arrhythmias, or unstable angina\n* Prior therapy with a KRAS G12C inhibitor'}, 'identificationModule': {'nctId': 'NCT05920356', 'briefTitle': 'A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': 'A Phase 3, Multicenter, Randomized, Open-label Study Evaluating Efficacy of Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Subjects With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers, Negative for PD-L1, and Positive for KRAS p.G12C (CodeBreaK 202)', 'orgStudyIdInfo': {'id': '20190341'}, 'secondaryIdInfos': [{'id': '2022-501863-41-00', 'type': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sotorasib combined with carboplatin and pemetrexed', 'description': 'Sotorasib administered in combination with carboplatin and pemetrexed.', 'interventionNames': ['Drug: Sotorasib']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pembrolizumab combined with carboplatin and pemetrexed', 'description': 'Pembrolizumab administered in combination with carboplatin and pemetrexed.', 'interventionNames': ['Drug: Pembrolizumab']}], 'interventions': [{'name': 'Sotorasib', 'type': 'DRUG', 'otherNames': ['AMG 510', 'LUMYKRAS ®', 'LUMAKRAS ®'], 'description': 'Oral administration', 'armGroupLabels': ['Sotorasib combined with carboplatin and pemetrexed']}, {'name': 'Pembrolizumab', 'type': 'DRUG', 'description': 'Intravenous administration', 'armGroupLabels': ['Pembrolizumab combined with carboplatin and pemetrexed']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93105', 'city': 'Santa Barbara', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Sansum Clinic', 'geoPoint': {'lat': 34.42083, 'lon': -119.69819}}, {'zip': '19713', 'city': 'Newark', 'state': 'Delaware', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Medical Oncology Hematology Consultants Helen F Graham Cancer Center', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Illinois Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60714', 'city': 'Niles', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Illinois Cancer Specialists', 'geoPoint': {'lat': 42.01892, 'lon': -87.80284}}, {'zip': '40241', 'city': 'Louisville', 'state': 'Kentucky', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Norton Cancer Institute - Brownsboro', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '01606', 'city': 'Worcester', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Reliant Medical Group Inc', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}, {'zip': '87131', 'city': 'Albuquerque', 'state': 'New Mexico', 'status': 'RECRUITING', 'country': 'United States', 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'affiliation': 'Amgen'}]}, 'ipdSharingStatementModule': {'url': 'http://www.amgen.com/datasharing', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.', 'ipdSharing': 'YES', 'description': 'De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request', 'accessCriteria': 'Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amgen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}