Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-26 @ 1:18 AM
Study NCT ID:
NCT04351334
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2020-04-15
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Anaplastic Lymphoma Kinase (ALK)-Positive Non-small Cell Lung Cancer (NSCLC) Post-alectinib Treatment Patterns
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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': 'C582670', 'term': 'alectinib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'For all-cause mortality: from start of treatment until date of death or censoring date, during study observation period (maximum up to 51 months); eligible data was studied during approximately 31 months of this retrospective study', 'description': 'This observational retrospective study retrieved data from medical records and the data existed as unstructured data. In these data sources, individual participant data were not retrieved or validated, and it was not possible to link a particular product and medical event for any individual. Thus, minimum criteria (identifiable participant, identifiable reporter, a suspect product, and event) for reporting an adverse event could not be met, hence safety data not collected and reported.', 'eventGroups': [{'id': 'EG000', 'title': 'All Eligible Participants', 'description': 'Participants who were on treatment with Alectinib for ALK+ NSCLC in real world clinical practices during 01-Jun-2017 to 31-Aug-2020.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 161, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 56, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Classified According to Treatments Received for Anaplastic Lymphoma Kinase Positive-non-Small Cell Lung Cancer (ALK + NSCLC) in Sequence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Eligible Participants', 'description': 'Participants who were on treatment with Alectinib for ALK+ NSCLC in real world clinical practices during 01-Jun-2017 to 31-Aug-2020.'}], 'classes': [{'categories': [{'title': 'Alectinib only', 'measurements': [{'value': '103', 'groupId': 'OG000'}]}, {'title': 'Alectinib followed by chemotherapy', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': 'Alectinib followed by lorlatinib', 'measurements': [{'value': '23', 'groupId': 'OG000'}]}, {'title': 'Alectinib followed by crizotinib', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Alectinib followed by immunotherapy', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Alectinib followed by brigatinib', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}, {'title': 'Alectinib followed by chemoimmunotherapy', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Alectinib followed by ceritinib', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Alectinib followed other', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the inclusion period from 01-Jun-2017 to 31-Aug-2020 (maximum up to 39 months); eligible data was studied during approximately 31 months of this retrospective study', 'description': 'Number of participants classified according to ALK-TKI treatment patterns or sequencing were reported in this outcome measure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose data were included and observed in this study.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Classified According to Reason for Alectinib Treatment Discontinuation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Eligible Participants', 'description': 'Participants who were on treatment with Alectinib for ALK+ NSCLC in real world clinical practices during 01-Jun-2017 to 31-Aug-2020.'}], 'classes': [{'title': 'Hospice', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Toxicity', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Death', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'Progression', 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}]}]}, {'title': 'Decline in performance status', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Participant choice', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Physician choice', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'No evidence of alectinib discontinuation', 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From initiation of index treatment to discontinuation from 01-Jun-2017 to 31-Aug-2021 (maximum up to 51 months); eligible data was studied during approximately 31 months of this retrospective study', 'description': 'Number of participants classified according to reason for Alectinib treatment discontinuation were reported in this outcome measure. One participant could have more than one reason for discontinuation.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose data were included and observed in this study.'}, {'type': 'PRIMARY', 'title': 'Duration of Therapy (DOT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Eligible Participants', 'description': 'Participants who were on treatment with Alectinib for ALK+ NSCLC in real world clinical practices during 01-Jun-2017 to 31-Aug-2020.'}], 'classes': [{'categories': [{'measurements': [{'value': '23.9', 'groupId': 'OG000', 'lowerLimit': '18.2', 'upperLimit': '31.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Alectinib or post-alectinib treatment initiation till its discontinuation or censoring date, during study observation period (maximum up to 51 months); eligible data was studied during approximately 31 months of this retrospective study', 'description': 'DOT was defined as duration of time between alectinib or post-alectinib treatment initiation and discontinuation as documented in the iKM EHR database. Participants who did not have evidence of discontinuation, starting new therapy, or whose last prescription date was less than (\\<) 30 days from the end of the study period, were censored at last visit date or end of study period.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose data were included and observed in this study.'}, {'type': 'PRIMARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Eligible Participants', 'description': 'Participants who were on treatment with Alectinib for ALK+ NSCLC in real world clinical practices during 01-Jun-2017 to 31-Aug-2020.'}], 'classes': [{'categories': [{'measurements': [{'value': '46.3', 'comment': 'Upper limit of 95% CI could not be estimated as there were insufficient number of participants with event and hence not available to report.', 'groupId': 'OG000', 'lowerLimit': '36.6', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From start of treatment until date of death or censoring date, during study observation period (maximum up to 51 months); eligible data was studied during approximately 31 months of this retrospective study', 'description': 'OS was defined as the interval between treatment and the date of death (any cause) as documented in the iKM EHR database. Participants who did not die within the study observation period were censored on the study end date or the last visit date available in the dataset, whichever occurred first.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose data were included and observed in this study.'}, {'type': 'PRIMARY', 'title': 'Progression Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Eligible Participants', 'description': 'Participants who were on treatment with Alectinib for ALK+ NSCLC in real world clinical practices during 01-Jun-2017 to 31-Aug-2020.'}], 'classes': [{'categories': [{'measurements': [{'value': '41.4', 'comment': 'Upper limit of 95% CI could not be estimated as there were insufficient number of participants with event and hence not available to report.', 'groupId': 'OG000', 'lowerLimit': '20.1', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From initiation of index treatment to date of progression or death due to any cause or censoring date, during study observation period (maximum up to 51 months); eligible data was studied during approximately 31 months of this retrospective study', 'description': 'PFS was measured from the initiation of the treatment to the date of progression (documented by provider as disease has progressed or worsening of disease) or date of death due to any cause, censoring participants who were still alive at the end of the study observation period and did not progress at the last visit date.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose data were included and observed in this study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Eligible Participants', 'description': 'Participants who were on treatment with Alectinib for ALK+ NSCLC in real world clinical practices during 01-Jun-2017 to 31-Aug-2020.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '161'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '161'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Participants with anaplastic lymphoma kinase + non-small cell lung cancer (ALK+ NSCLC) who were on treatment with Alectinib during 01 June 2017 and 31 August 2020 were eligible for this study. Data of eligible participants from 01 June 2017 to 31 August 2021, were extracted from iKnowMed (iKM) electronic health record (EHR). Data was evaluated per objectives of this retrospective observational study from 27 March 2020 to 01 November 2022.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Eligible Participants', 'description': 'Participants who were on treatment with Alectinib for ALK+ NSCLC in real world clinical practices during 01-Jun-2017 to 31-Aug-2020.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.4', 'spread': '13.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '91', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '70', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '111', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Participants According to Practice Region', 'classes': [{'categories': [{'title': 'Midwest', 'measurements': [{'value': '34', 'groupId': 'BG000'}]}, {'title': 'Northeast', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'South', 'measurements': [{'value': '58', 'groupId': 'BG000'}]}, {'title': 'West', 'measurements': [{'value': '60', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number of participants classified according to practice region were reported in this baseline characteristic.', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Participants Classified According to Smoking History', 'classes': [{'categories': [{'title': 'Current', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Former', 'measurements': [{'value': '51', 'groupId': 'BG000'}]}, {'title': 'Never', 'measurements': [{'value': '81', 'groupId': 'BG000'}]}, {'title': 'No information', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number for participants classified according to smoking history were reported in this baseline characteristic.', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Participants According to Eastern Cooperative Oncology Group (ECOG) Performance Score', 'classes': [{'categories': [{'title': '0', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': '1', 'measurements': [{'value': '70', 'groupId': 'BG000'}]}, {'title': '2', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'Greater than or equal to (>=) 3', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Not documented', 'measurements': [{'value': '51', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "The ECOG performance status score is a rating of a participant's disease status, daily living activities and quality of life, where 0 indicates fully active,1 indicates restricted in physically strenuous activity, 2 indicates ambulatory and capable of self-care but unable to work, 3 indicates capable only of limited self-care, 4 indicates completely disabled and 5 indicates dead. Higher scores indicated more severe disease, difficulty in performing daily activity and poor quality of life.", 'unitOfMeasure': 'Participants'}, {'title': 'Number of Participants According to Tumor Histology', 'classes': [{'categories': [{'title': 'Adenosquamous carcinoma', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Large cell carcinoma', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Adenocarcinoma', 'measurements': [{'value': '132', 'groupId': 'BG000'}]}, {'title': 'Other', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Squamous cell carcinoma', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Not documented', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number of participants classified according to tumor histology were reported in this baseline characteristic.', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Participants According to Stage at Initial NSCLC Diagnosis', 'classes': [{'categories': [{'title': 'Early Stage (IA, IB, II [not specified], IIA)', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'Stage III (Not specified)', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Limited/Regional (IIIA)', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Locally advanced (IIIB/IIIC)', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Metastatic (IV)', 'measurements': [{'value': '129', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'In this baseline measure disease stage at initial NSCLC diagnosis was categorized as a) Early stage ((IA, IB, IIA, IIIB, II not specified); b) participants identified as stage III but without any record of A, B or C (III not specified); c) Limited/Regional (IIIA); d) Locally advanced (IIIB, IIIC); e) Metastatic (IV) and f) Unknown. The higher the stage number, the larger the tumor and/or the more it has spread into nearby tissues.', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Participants According to ROS Proto-Oncogene 1 (ROS1) Status', 'classes': [{'categories': [{'title': 'Positive', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Negative', 'measurements': [{'value': '78', 'groupId': 'BG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'Not documented', 'measurements': [{'value': '68', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number of participants classified according to ROS1 status was reported in this baseline characteristic. Unknown might have included results classified as unknown or pending. Not documented indicated that there was no documentation of testing results.', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Participants According to Epidermal Growth Factor Receptor (EGFR) Mutation Status', 'classes': [{'categories': [{'title': 'Positive', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Negative', 'measurements': [{'value': '114', 'groupId': 'BG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Not documented', 'measurements': [{'value': '41', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number of participants classified according to EGFR mutation status was reported in this baseline characteristic. Unknown might have included results classified as unknown or pending. Not documented indicated that there was no documentation of testing results.', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Participants According to v-raf Murine Sarcoma Viral Oncogene Homolog B1 Mutation Status', 'classes': [{'categories': [{'title': 'Positive', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Wild-type', 'measurements': [{'value': '65', 'groupId': 'BG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '36', 'groupId': 'BG000'}]}, {'title': 'Not documented', 'measurements': [{'value': '60', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number of participants classified according to v-raf murine sarcoma viral oncogene homolog B1 (BRAF) mutation status was reported in this baseline characteristic. Unknown might have included results classified as unknown or pending. Not documented indicated that there was no documentation of testing results.', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Participants According to Programmed Death-Ligand 1 (PD-L1) Expression', 'classes': [{'categories': [{'title': '1-49 percent (%) Expression', 'measurements': [{'value': '38', 'groupId': 'BG000'}]}, {'title': '>= 50% Expression', 'measurements': [{'value': '38', 'groupId': 'BG000'}]}, {'title': 'Negative', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '28', 'groupId': 'BG000'}]}, {'title': 'Not documented', 'measurements': [{'value': '42', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number of participants classified according to PD-L1 expression was reported in this baseline characteristic. Unknown might have included results classified as unknown or pending. Not documented indicated that there was no documentation of testing results.', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Analysis population included all eligible participants whose data were included and observed in this study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-08-31', 'size': 885771, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-11-01T12:03', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 161}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-16', 'studyFirstSubmitDate': '2020-04-15', 'resultsFirstSubmitDate': '2023-11-01', 'studyFirstSubmitQcDate': '2020-04-15', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-05-16', 'studyFirstPostDateStruct': {'date': '2020-04-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Classified According to Treatments Received for Anaplastic Lymphoma Kinase Positive-non-Small Cell Lung Cancer (ALK + NSCLC) in Sequence', 'timeFrame': 'During the inclusion period from 01-Jun-2017 to 31-Aug-2020 (maximum up to 39 months); eligible data was studied during approximately 31 months of this retrospective study', 'description': 'Number of participants classified according to ALK-TKI treatment patterns or sequencing were reported in this outcome measure.'}, {'measure': 'Number of Participants Classified According to Reason for Alectinib Treatment Discontinuation', 'timeFrame': 'From initiation of index treatment to discontinuation from 01-Jun-2017 to 31-Aug-2021 (maximum up to 51 months); eligible data was studied during approximately 31 months of this retrospective study', 'description': 'Number of participants classified according to reason for Alectinib treatment discontinuation were reported in this outcome measure. One participant could have more than one reason for discontinuation.'}, {'measure': 'Duration of Therapy (DOT)', 'timeFrame': 'Alectinib or post-alectinib treatment initiation till its discontinuation or censoring date, during study observation period (maximum up to 51 months); eligible data was studied during approximately 31 months of this retrospective study', 'description': 'DOT was defined as duration of time between alectinib or post-alectinib treatment initiation and discontinuation as documented in the iKM EHR database. Participants who did not have evidence of discontinuation, starting new therapy, or whose last prescription date was less than (\\<) 30 days from the end of the study period, were censored at last visit date or end of study period.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'From start of treatment until date of death or censoring date, during study observation period (maximum up to 51 months); eligible data was studied during approximately 31 months of this retrospective study', 'description': 'OS was defined as the interval between treatment and the date of death (any cause) as documented in the iKM EHR database. Participants who did not die within the study observation period were censored on the study end date or the last visit date available in the dataset, whichever occurred first.'}, {'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'From initiation of index treatment to date of progression or death due to any cause or censoring date, during study observation period (maximum up to 51 months); eligible data was studied during approximately 31 months of this retrospective study', 'description': 'PFS was measured from the initiation of the treatment to the date of progression (documented by provider as disease has progressed or worsening of disease) or date of death due to any cause, censoring participants who were still alive at the end of the study observation period and did not progress at the last visit date.'}]}, 'conditionsModule': {'conditions': ['Non-Small-Cell Lung Carcinoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=B7461031', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to understand patient profiles, treatment patterns, and clinical outcomes among ALK-positive NSCLC patients treated with alectinib, and post-alectinib treatment patterns and outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will consist of patients with a diagnosis of NSCLC receiving alectinib.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with a documented diagnosis of NSCLC.\n2. Patients ≥ 18 years of age at initial recorded diagnosis of NSCLC.\n3. Patients who received treatment with alectinib during the study identification period, including those who initiated alectinib prior (index date-1) to the start of the study identification period.\n4. During the study observation period, patients observed with at least 2 visits after the index date-1.\n\nExclusion Criteria:\n\n1. Receipt of treatment indicated for another primary cancer or diagnosis of another primary cancer (with the exception of non-melanotic skin cancer), within 5 years of index date-1 will be excluded.\n2. Patients enrolled in clinical trials prior to receiving alectinib during the study ID period (index date-1), will be included and flagged in the analysis.'}, 'identificationModule': {'nctId': 'NCT04351334', 'briefTitle': 'Anaplastic Lymphoma Kinase (ALK)-Positive Non-small Cell Lung Cancer (NSCLC) Post-alectinib Treatment Patterns', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Patient Profiles and Treatment Patterns Among ALK-positive NSCLC Patients Treated With Alectinib', 'orgStudyIdInfo': {'id': 'B7461031'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with ALK-positive NSCLC', 'interventionNames': ['Drug: Alectinib']}], 'interventions': [{'name': 'Alectinib', 'type': 'DRUG', 'description': 'Observational treatment based on physician choice', 'armGroupLabels': ['Patients with ALK-positive NSCLC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10017', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Pfizer Inc', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}