Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 8:53 PM
Study NCT ID:
NCT07413757
Status:
RECRUITING
Last Update Posted:
2026-03-25
First Post:
2026-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CHOICE:Decision Factor of EGFR-TKI in Chinese IV NSCLC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 590}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-24', 'studyFirstSubmitDate': '2026-02-09', 'studyFirstSubmitQcDate': '2026-02-09', 'lastUpdatePostDateStruct': {'date': '2026-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Preferences weights for each attribute level evaluated in the DCE', 'timeFrame': 'Day of interview/survey completion(Day1)', 'description': 'Preference weights will be estimated for each attribute level included in the DCE where a more positive preference weight indicates a stronger preference for the attribute level. The preference weights allow for comparison for relative preference for levels within the same attribute.'}, {'measure': 'Relative attribute importance (RAI)', 'timeFrame': 'Day of interview/survey completion(Day1)', 'description': 'The importance measure will be used to evaluate the preferences among treatment attributes. This measure will be calculated by using the difference of utility scores between the most and least preferred levels within an attribute. Then, this measure will divide by the summation of the difference of all tested attributes.'}], 'secondaryOutcomes': [{'measure': 'Maximum acceptable risks (MAR) and minimum acceptable benefit (MAB)', 'timeFrame': 'Day of interview/survey completion(Day1)', 'description': 'This measure will be used to evaluate the trade-offs participants are willing to make between an improvement in a pre-defined attribute related to efficiency (such as PFS) compared to a worsening in each AE relevant attribute (such as rash).\n\n* MAR quantifies the average maximum level of risk factors (e.g., incidence of rash, incidence of diarrhea, etc.) that participants are willing to tolerate in exchange for a specified improvement in clinical outcomes.\n* MAB represents the minimum level of benefit required to justify an increase in risk. It is derived from the marginal rate of substitution (MRS) between risk and benefit attributes, calculated using the estimated preference weights from the DCE model.'}, {'measure': 'RAI, MAR, and MAB by patient and physician characteristics subgroups', 'timeFrame': 'Day of interview/survey completion(Day1)', 'description': '* RAI quantifies the relative weight participants place on each attribute (e.g., efficacy vs. side effects) in their decision-making.\n* MAR and MAB will be estimated separately for subgroups defined by patient (e.g., age, gender, with/without central nervous system \\[CNS\\] metastasis) and physician (e.g., title, years of experience) characteristics.'}, {'measure': 'Odds ratios (ORs) for the association between patient characteristics and the likelihood of physicians recommending combination therapy (EGFR-TKI plus platinum/pemetrexed chemotherapy or EGFR-TKI plus bispecific antibody) versus EGFR-TKI monotherapy', 'timeFrame': 'Day of interview/survey completion(Day1)', 'description': 'o OR quantifies changes in the likelihood of physicians recommending combination therapy over monotherapy, depending on the presence or absence of specific patient characteristics (e.g., age, CNS metastases, high tumor burden). An OR \\> 1 indicates an increased likelihood of recommending combination therapy for patients with the characteristic, while an OR \\< 1 indicates a decreased likelihood.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['NSCLC;patients and physicians;survey;EGFR-TKI;patient preference;physician preference'], 'conditions': ['Non-Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'This non-interventional, cross-sectional study aims to investigate treatment preferences from a sample of physicians and patients with experience of 1L EGFR-TKI for stage IV NSCLC by administering a survey, which primarily includes a DCE approach.', 'detailedDescription': 'This non-interventional, cross-sectional study aims to investigate treatment preferences from a sample of physicians and patients with experience of 1L EGFR-TKI for stage IV NSCLC by administering a survey, which primarily includes a DCE approach.\n\nThe study will collect data from participants via the questionnaire developed by the research team. This study will be conducted in two stages. Stage 1 is the study design phase (i.e., qualitative stage and questionnaire development), which includes the development of the questionnaire, identification of key attributes and levels for the Discrete Choice Experiment (DCE), creation of hypothetical patient profiles to explore high-risk factors in physician decision-making beyond the DCE, as well as questionnaire programming, internal review, pilot testing, revisions, and finalization. Stage 2 involves the implementation of the quantitative survey using the finalized questionnaire and the subsequent data analysis to generate insights into treatment preferences.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will include patients receiving or who have received 1L EGFR-TKI treatment for stage IV NSCLC and physicians who have experience in the treatment and management of stage IV NSCLC patients with 1L EGFR-TKI. To improve the sample representativeness and generalizability, some soft quotas may be applied during sampling. All the participants who met inclusion criteria will be included.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nThe following inclusion criteria must be met in order to be enrolled in the stage 1:\n\nPatient:\n\n* Provide informed consent\n* 18 years or older\n* Diagnosed with stage IV NSCLC\n* Currently receiving or previously received 1L EGFR-TKI treatment\n* Without communication barrier\n* Do not exhibit signs of cognitive impairment that would prevent participation in an interview, as informally assessed during screening by the recruiter\n\nPhysician:\n\n* Provide informed consent\n* Specialized in departments of medical oncology, respiratory medicine, or thoracic surgery at tertiary hospitals\n* Manage at least 3 stage IV NSCLC patients with 1L EGFR-TKI per month\n* Holding the title of associate chief physician or higher\n\nThe following inclusion criteria must be met in order to be enrolled in the stage 2:\n\nPatient:\n\n* Provide informed consent\n* 18 years or older\n* Diagnosed with stage IV NSCLC\n* Currently receiving or previously received 1L EGFR-TKI treatment\n* Without communication barrier\n* Do not exhibit signs of cognitive impairment that would prevent participation in a survey, as informally assessed during screening by the recruiter\n\nPhysician:\n\n* Provide informed consent\n* Specialized in departments of medical oncology, respiratory medicine, or thoracic surgery at tertiary hospitals\n* Manage at least 3 stage IV NSCLC patients with 1L EGFR-TKI per month\n* Holding the title of attending physician or higher\n\nExclusion Criteria:\n\nNot applicable.'}, 'identificationModule': {'nctId': 'NCT07413757', 'acronym': 'CHOICE', 'briefTitle': 'CHOICE:Decision Factor of EGFR-TKI in Chinese IV NSCLC', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Cross-sectional Survey-based Study Using Preference Elicitation Method to Assess Decision-making Impact Factor of Chinese Patients and Physicians for First-line EGFR-TKIs Treatment of Stage IV NSCLC (CHOICE)', 'orgStudyIdInfo': {'id': 'D5161R00072'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Physicians group', 'description': 'Physicians who have experience in the treatment and management of stage IV NSCLC patients with 1L EGFR-TKI.'}, {'label': 'Patinet group', 'description': 'Patients receiving or who have received 1L EGFR-TKI treatment for stage IV NSCLC'}]}, 'contactsLocationsModule': {'locations': [{'zip': '610000', 'city': 'Chengdu', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}], 'centralContacts': [{'name': 'AstraZeneca Clinical Study Information Center', 'role': 'CONTACT', 'email': 'information.center@astrazeneca.com', 'phone': '1-877-240-9479'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/', 'timeFrame': 'AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.', 'ipdSharing': 'YES', 'description': 'Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.\n\nYes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.', 'accessCriteria': 'When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}