Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-02-22 @ 5:23 PM
Study NCT ID:
NCT06497556
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-05
First Post:
2024-07-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Evaluating the Efficacy and Safety of Divarasib Versus Sotorasib or Adagrasib in Participants With Previously Treated KRAS G12C-positive Advanced or Metastatic 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': 'C000706028', 'term': 'sotorasib'}, {'id': 'C000718190', 'term': 'adagrasib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 320}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-09-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2029-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-04', 'studyFirstSubmitDate': '2024-07-05', 'studyFirstSubmitQcDate': '2024-07-05', 'lastUpdatePostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'Up to approximately 4 years', 'description': 'PFS is defined as the time from randomization to the first occurrence of disease progression, as determined by blinded independent central review (BICR) according to RECIST v1.1, or death from any cause (whichever occurs first)'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to approximately 4 years', 'description': 'OS is defined as the time from randomization to death from any cause'}, {'measure': 'Confirmed Objective Response', 'timeFrame': 'Up to approximately 4 years', 'description': 'Confirmed objective response is defined as complete response (CR) or partial response (PR) on two occasions ≥ 4 weeks apart, as determined by BICR according to RECIST v1.1'}, {'measure': 'Time to Confirmed Deterioration (TTCD) on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Dyspnea Item and Physical Functioning Scale', 'timeFrame': 'Baseline up to approximately 4 years'}, {'measure': 'TTCD on the EORTC Quality-of-Life Questionnaire-Supplemental Lung Cancer Module (QLQ-LC13) Cough Scale', 'timeFrame': 'Baseline up to approximately 4 years'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'Up to approximately 4 years', 'description': 'DOR is defined as the time from the first occurrence of a documented confirmed objective response to disease progression, as determined by BICR according to RECIST v1.1, or death from any cause (whichever occurs first)'}, {'measure': 'Percentage of Participants with Adverse Events (AEs)', 'timeFrame': 'Up to approximately 4 years'}, {'measure': 'Number of Participants Reporting Presence, Frequency, Severity, and/or Degree of Interference with Daily Function of Symptomatic Treatment Toxicities Assessed by NCI Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE)', 'timeFrame': 'Up to approximately 4 years'}, {'measure': 'Change from Baseline in Diarrhea, Nausea, Vomiting, Anorexia, Alopecia, Dyspnea, Cough, Constipation, Myalgia, Headache, and Rash/Acne as Assessed Through use of the NCI PRO-CTCAE', 'timeFrame': 'Baseline up to approximately 4 years'}, {'measure': "Frequency of Participants' Response of the Degree they are Troubled with Treatment Symptoms, as Assessed Through use of the single-item EORTC Item List (IL46)", 'timeFrame': 'Up to approximately 4 years'}, {'measure': 'Change from Baseline in Cough, Chest Pain, Dyspnea, Physical and Role Functioning, and Global Health Status score/Quality of Life Score (GHS/QoL) at Each Timepoint as Assessed Through use of the EORTC QLQ-LC13 and QLQ-C30', 'timeFrame': 'Baseline up to approximately 4 years'}, {'measure': 'TTCD on the EORTC QLQ-C30 Role Functioning and GHS/QoL scales', 'timeFrame': 'Up to approximately 4 years'}, {'measure': 'TTCD on the Chest Pain Scale of the QLQ-LC13 Scales', 'timeFrame': 'Up to approximately 4 years'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Advanced Non-Small Cell Lung Cancer', 'KRAS G12 Lung Cancer', 'Advanced Lung Cancer', 'Metastatic lung cancer', 'Divarasib', 'KRAS G12C Inhibitor', 'KRAS G12C Positive', 'KRAS Mutation', 'KRAS G12C Mutation', 'Lung Cancer Mutation'], 'conditions': ['Non-Small Cell Lung Cancer', 'KRAS G12C Lung Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the safety and efficacy of divarasib compared to locally approved KRAS G12C inhibitors (sotorasib or adagrasib) in participants with KRAS G12C-positive (KRAS G12C +) advanced or metastatic non-small cell lung cancer (NSCLC).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Unequivocal histologically or cytologically confirmed diagnosis of metastatic or locally advanced NSCLC not amenable to treatment with surgical resection or combined chemoradiation\n* Disease progression during or after treatment with at least one prior systemic therapy but no more than three lines of prior systemic therapy in the advanced or metastatic setting\n* Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1\n* Documentation of the presence of a KRAS G12C mutation\n* Availability of a representative formalin-fixed, paraffin-embedded (FFPE) tumor specimen in a paraffin block (preferred) or 10-15 (15 preferred) unstained, freshly cut, serial slides with an associated pathology report\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Life expectancy of \\>= 12 weeks\n\nExclusion Criteria:\n\n* Known hypersensitivity to any of the components of divarasib, or sotorasib or adagrasib\n* Malabsorption syndrome or other condition that would interfere with enteral absorption\n* Known concomitant second oncogenic driver\n* Mixed small-cell lung cancer or large cell neuroendocrine histology\n* Known and untreated, or active central nervous system (CNS) metastases\n* Leptomeningeal disease or carcinomatous meningitis\n* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures biweekly or more frequently\n* Any infection that, in the opinion of the investigator, could impact patient safety, or treatment with therapeutic oral or IV antibiotics within 14 days prior to Day 1 of Cycle 1\n* Prior treatment with any KRAS G12C inhibitor or pan-KRAS/RAS inhibitor\n* More than 30 Gy of radiotherapy to the lung within 6 months of randomization\n* Uncontrolled tumor-related pain\n* Unresolved toxicities from prior anticancer therapy\n* History of malignancy within 5 years prior to screening, with the exception of the cancer under investigation in this study and malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate \\>90%), such as adequately treated carcinoma in situ of the cervix, nonmelanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer'}, 'identificationModule': {'nctId': 'NCT06497556', 'acronym': 'Krascendo 1', 'briefTitle': 'A Study Evaluating the Efficacy and Safety of Divarasib Versus Sotorasib or Adagrasib in Participants With Previously Treated KRAS G12C-positive Advanced or Metastatic Non-Small Cell Lung Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Phase III, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Divarasib Versus Sotorasib or Adagrasib in Patients With Previously Treated KRAS G12C-Positive Advanced or Metastatic Non-Small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'BO45217'}, 'secondaryIdInfos': [{'id': '2024-510908-37-00', 'type': 'OTHER', 'domain': 'EU CT Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Divarasib', 'description': 'Participants will receive divarasib orally, once daily (QD).', 'interventionNames': ['Drug: Divarasib']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'KRAS G12C inhibitor', 'description': 'Participants will receive sotorasib orally QD or adagrasib orally twice a day (BID)', 'interventionNames': ['Drug: Sotorasib', 'Drug: Adagrasib']}], 'interventions': [{'name': 'Divarasib', 'type': 'DRUG', 'description': 'Divarasib will be administered orally QD', 'armGroupLabels': ['Divarasib']}, {'name': 'Sotorasib', 'type': 'DRUG', 'description': 'Sotorasib will be administered orally QD', 'armGroupLabels': ['KRAS G12C inhibitor']}, {'name': 'Adagrasib', 'type': 'DRUG', 'description': 'Adagrasib will be administred orally BID', 'armGroupLabels': ['KRAS G12C inhibitor']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85234', 'city': 'Gilbert', 'state': 'Arizona', 'country': 'United States', 'facility': 'Banner Health MD Anderson AZ', 'geoPoint': {'lat': 33.35283, 'lon': -111.78903}}, {'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Banner Health MD Anderson AZ', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'University of Arkansas For Medical Sciences', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '90017-4803', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Los Angeles Cancer Network', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Hematology / Oncology Clinic', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'Community Clinical Trials', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '94110', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Zuckerberg San Francisco General Hospital', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94158', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80909', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'UC Health Oncology Research', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '06519', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale Cancer Center', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '33744', 'city': 'Bay Pines', 'state': 'Florida', 'country': 'United States', 'facility': 'Bay Pines Foundation Inc', 'geoPoint': {'lat': 27.81419, 'lon': -82.77816}}, {'zip': '33901', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Cancer Specialists', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': 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'state': 'Nevada', 'country': 'United States', 'facility': 'Renown Regional Medical Center Hospital', 'geoPoint': {'lat': 39.52963, 'lon': -119.8138}}, {'zip': '11042-1116', 'city': 'New Hyde Park', 'state': 'New York', 'country': 'United States', 'facility': 'New York Cancer & Blood Specialists - New Hyde Park', 'geoPoint': {'lat': 40.7351, 'lon': -73.68791}}, {'zip': '10028', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York Cancer and Blood Specialists-Central Park Hematology & Oncology', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11967', 'city': 'Shirley', 'state': 'New York', 'country': 'United States', 'facility': 'North Shore Hematology Oncology Associates P.C. 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