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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with ALK-positive NSCLC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alectinib | Drug | Observational treatment based on physician choice |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Classified According to Treatments Received for Anaplastic Lymphoma Kinase Positive-non-Small Cell Lung Cancer (ALK + NSCLC) in Sequence | Number of participants classified according to ALK-TKI treatment patterns or sequencing were reported in this outcome measure. | 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 |
| Number of Participants Classified According to Reason for Alectinib Treatment Discontinuation | 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. | 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 |
| Duration of Therapy (DOT) | 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. | 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 |
| Overall Survival (OS) | 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. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will consist of patients with a diagnosis of NSCLC receiving alectinib.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Inc | New York | New York | 10017 | United States |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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.
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Eligible Participants | Participants who were on treatment with Alectinib for ALK+ NSCLC in real world clinical practices during 01-Jun-2017 to 31-Aug-2020. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Analysis population included all eligible participants whose data were included and observed in this study.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Eligible Participants | Participants who were on treatment with Alectinib for ALK+ NSCLC in real world clinical practices during 01-Jun-2017 to 31-Aug-2020. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Classified According to Treatments Received for Anaplastic Lymphoma Kinase Positive-non-Small Cell Lung Cancer (ALK + NSCLC) in Sequence | Number of participants classified according to ALK-TKI treatment patterns or sequencing were reported in this outcome measure. | Analysis population included all eligible participants whose data were included and observed in this study. | Posted | Count of Participants | Participants | 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 |
|
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
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Eligible Participants | Participants who were on treatment with Alectinib for ALK+ NSCLC in real world clinical practices during 01-Jun-2017 to 31-Aug-2020. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 31, 2021 | Nov 1, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| C582670 | alectinib |
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| Progression Free Survival (PFS) | 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. | 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 |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Number of Participants According to Practice Region | Number of participants classified according to practice region were reported in this baseline characteristic. | Count of Participants | Participants |
|
| Number of Participants Classified According to Smoking History | Number for participants classified according to smoking history were reported in this baseline characteristic. | Count of Participants | Participants |
|
| Number of Participants According to Eastern Cooperative Oncology Group (ECOG) Performance Score | 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. | Count of Participants | Participants |
|
| Number of Participants According to Tumor Histology | Number of participants classified according to tumor histology were reported in this baseline characteristic. | Count of Participants | Participants |
|
| Number of Participants According to Stage at Initial NSCLC Diagnosis | 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. | Count of Participants | Participants |
|
| Number of Participants According to ROS Proto-Oncogene 1 (ROS1) Status | 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. | Count of Participants | Participants |
|
| Number of Participants According to Epidermal Growth Factor Receptor (EGFR) Mutation Status | 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. | Count of Participants | Participants |
|
| Number of Participants According to v-raf Murine Sarcoma Viral Oncogene Homolog B1 Mutation Status | 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. | Count of Participants | Participants |
|
| Number of Participants According to Programmed Death-Ligand 1 (PD-L1) Expression | 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. | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Number of Participants Classified According to Reason for Alectinib Treatment Discontinuation | 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. | Analysis population included all eligible participants whose data were included and observed in this study. | Posted | Count of Participants | Participants | 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 |
|
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| Primary | Duration of Therapy (DOT) | 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. | Analysis population included all eligible participants whose data were included and observed in this study. | Posted | Median | 95% Confidence Interval | Months | 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 |
|
|
|
| Primary | Overall Survival (OS) | 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. | Analysis population included all eligible participants whose data were included and observed in this study. | Posted | Median | 95% Confidence Interval | Months | 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 |
|
|
|
| Primary | Progression Free Survival (PFS) | 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. | Analysis population included all eligible participants whose data were included and observed in this study. | Posted | Median | 95% Confidence Interval | Months | 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 |
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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.
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Title | Measurements |
|---|
|
| Progression |
|
| Decline in performance status |
|
| Participant choice |
|
| Physician choice |
|
| Unknown |
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| Other |
|
| No evidence of alectinib discontinuation |
|