Trial Outcomes & Findings for Anaplastic Lymphoma Kinase (ALK)-Positive Non-small Cell Lung Cancer (NSCLC) Post-alectinib Treatment Patterns (NCT NCT04351334)
NCT ID: NCT04351334
Last Updated: 2024-09-19
Results Overview
Number of participants classified according to ALK-TKI treatment patterns or sequencing were reported in this outcome measure.
Recruitment status
COMPLETED
Target enrollment
161 participants
Primary outcome 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
Results posted on
2024-09-19
Participant Flow
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.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
161
|
|
Overall Study
COMPLETED
|
161
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Anaplastic Lymphoma Kinase (ALK)-Positive Non-small Cell Lung Cancer (NSCLC) Post-alectinib Treatment Patterns
Baseline characteristics by cohort
| Measure |
All Eligible Participants
n=161 Participants
Participants who were on treatment with Alectinib for ALK+ NSCLC in real world clinical practices during 01-Jun-2017 to 31-Aug-2020.
|
|---|---|
|
Age, Continuous
|
61.4 Years
STANDARD_DEVIATION 13.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
91 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
70 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
111 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
27 Participants
n=5 Participants
|
|
Number of Participants According to Practice Region
Midwest
|
34 Participants
n=5 Participants
|
|
Number of Participants According to Practice Region
Northeast
|
9 Participants
n=5 Participants
|
|
Number of Participants According to Practice Region
South
|
58 Participants
n=5 Participants
|
|
Number of Participants According to Practice Region
West
|
60 Participants
n=5 Participants
|
|
Number of Participants Classified According to Smoking History
Current
|
5 Participants
n=5 Participants
|
|
Number of Participants Classified According to Smoking History
Former
|
51 Participants
n=5 Participants
|
|
Number of Participants Classified According to Smoking History
Never
|
81 Participants
n=5 Participants
|
|
Number of Participants Classified According to Smoking History
No information
|
24 Participants
n=5 Participants
|
|
Number of Participants According to Eastern Cooperative Oncology Group (ECOG) Performance Score
0
|
18 Participants
n=5 Participants
|
|
Number of Participants According to Eastern Cooperative Oncology Group (ECOG) Performance Score
1
|
70 Participants
n=5 Participants
|
|
Number of Participants According to Eastern Cooperative Oncology Group (ECOG) Performance Score
2
|
20 Participants
n=5 Participants
|
|
Number of Participants According to Eastern Cooperative Oncology Group (ECOG) Performance Score
Greater than or equal to (>=) 3
|
2 Participants
n=5 Participants
|
|
Number of Participants According to Eastern Cooperative Oncology Group (ECOG) Performance Score
Not documented
|
51 Participants
n=5 Participants
|
|
Number of Participants According to Tumor Histology
Adenosquamous carcinoma
|
2 Participants
n=5 Participants
|
|
Number of Participants According to Tumor Histology
Large cell carcinoma
|
1 Participants
n=5 Participants
|
|
Number of Participants According to Tumor Histology
Adenocarcinoma
|
132 Participants
n=5 Participants
|
|
Number of Participants According to Tumor Histology
Other
|
2 Participants
n=5 Participants
|
|
Number of Participants According to Tumor Histology
Squamous cell carcinoma
|
2 Participants
n=5 Participants
|
|
Number of Participants According to Tumor Histology
Not documented
|
22 Participants
n=5 Participants
|
|
Number of Participants According to Stage at Initial NSCLC Diagnosis
Early Stage (IA, IB, II [not specified], IIA)
|
13 Participants
n=5 Participants
|
|
Number of Participants According to Stage at Initial NSCLC Diagnosis
Stage III (Not specified)
|
1 Participants
n=5 Participants
|
|
Number of Participants According to Stage at Initial NSCLC Diagnosis
Limited/Regional (IIIA)
|
12 Participants
n=5 Participants
|
|
Number of Participants According to Stage at Initial NSCLC Diagnosis
Locally advanced (IIIB/IIIC)
|
6 Participants
n=5 Participants
|
|
Number of Participants According to Stage at Initial NSCLC Diagnosis
Metastatic (IV)
|
129 Participants
n=5 Participants
|
|
Number of Participants According to ROS Proto-Oncogene 1 (ROS1) Status
Positive
|
0 Participants
n=5 Participants
|
|
Number of Participants According to ROS Proto-Oncogene 1 (ROS1) Status
Negative
|
78 Participants
n=5 Participants
|
|
Number of Participants According to ROS Proto-Oncogene 1 (ROS1) Status
Unknown
|
15 Participants
n=5 Participants
|
|
Number of Participants According to ROS Proto-Oncogene 1 (ROS1) Status
Not documented
|
68 Participants
n=5 Participants
|
|
Number of Participants According to Epidermal Growth Factor Receptor (EGFR) Mutation Status
Positive
|
2 Participants
n=5 Participants
|
|
Number of Participants According to Epidermal Growth Factor Receptor (EGFR) Mutation Status
Negative
|
114 Participants
n=5 Participants
|
|
Number of Participants According to Epidermal Growth Factor Receptor (EGFR) Mutation Status
Unknown
|
4 Participants
n=5 Participants
|
|
Number of Participants According to Epidermal Growth Factor Receptor (EGFR) Mutation Status
Not documented
|
41 Participants
n=5 Participants
|
|
Number of Participants According to v-raf Murine Sarcoma Viral Oncogene Homolog B1 Mutation Status
Positive
|
0 Participants
n=5 Participants
|
|
Number of Participants According to v-raf Murine Sarcoma Viral Oncogene Homolog B1 Mutation Status
Wild-type
|
65 Participants
n=5 Participants
|
|
Number of Participants According to v-raf Murine Sarcoma Viral Oncogene Homolog B1 Mutation Status
Unknown
|
36 Participants
n=5 Participants
|
|
Number of Participants According to v-raf Murine Sarcoma Viral Oncogene Homolog B1 Mutation Status
Not documented
|
60 Participants
n=5 Participants
|
|
Number of Participants According to Programmed Death-Ligand 1 (PD-L1) Expression
1-49 percent (%) Expression
|
38 Participants
n=5 Participants
|
|
Number of Participants According to Programmed Death-Ligand 1 (PD-L1) Expression
>= 50% Expression
|
38 Participants
n=5 Participants
|
|
Number of Participants According to Programmed Death-Ligand 1 (PD-L1) Expression
Negative
|
15 Participants
n=5 Participants
|
|
Number of Participants According to Programmed Death-Ligand 1 (PD-L1) Expression
Unknown
|
28 Participants
n=5 Participants
|
|
Number of Participants According to Programmed Death-Ligand 1 (PD-L1) Expression
Not documented
|
42 Participants
n=5 Participants
|
PRIMARY outcome
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 studyPopulation: Analysis population included all eligible participants whose data were included and observed in this study.
Number of participants classified according to ALK-TKI treatment patterns or sequencing were reported in this outcome measure.
Outcome measures
| Measure |
All Eligible Participants
n=161 Participants
Participants who were on treatment with Alectinib for ALK+ NSCLC in real world clinical practices during 01-Jun-2017 to 31-Aug-2020.
|
|---|---|
|
Number of Participants Classified According to Treatments Received for Anaplastic Lymphoma Kinase Positive-non-Small Cell Lung Cancer (ALK + NSCLC) in Sequence
Alectinib followed by immunotherapy
|
2 Participants
|
|
Number of Participants Classified According to Treatments Received for Anaplastic Lymphoma Kinase Positive-non-Small Cell Lung Cancer (ALK + NSCLC) in Sequence
Alectinib only
|
103 Participants
|
|
Number of Participants Classified According to Treatments Received for Anaplastic Lymphoma Kinase Positive-non-Small Cell Lung Cancer (ALK + NSCLC) in Sequence
Alectinib followed by chemotherapy
|
8 Participants
|
|
Number of Participants Classified According to Treatments Received for Anaplastic Lymphoma Kinase Positive-non-Small Cell Lung Cancer (ALK + NSCLC) in Sequence
Alectinib followed by lorlatinib
|
23 Participants
|
|
Number of Participants Classified According to Treatments Received for Anaplastic Lymphoma Kinase Positive-non-Small Cell Lung Cancer (ALK + NSCLC) in Sequence
Alectinib followed by crizotinib
|
1 Participants
|
|
Number of Participants Classified According to Treatments Received for Anaplastic Lymphoma Kinase Positive-non-Small Cell Lung Cancer (ALK + NSCLC) in Sequence
Alectinib followed by brigatinib
|
15 Participants
|
|
Number of Participants Classified According to Treatments Received for Anaplastic Lymphoma Kinase Positive-non-Small Cell Lung Cancer (ALK + NSCLC) in Sequence
Alectinib followed by chemoimmunotherapy
|
4 Participants
|
|
Number of Participants Classified According to Treatments Received for Anaplastic Lymphoma Kinase Positive-non-Small Cell Lung Cancer (ALK + NSCLC) in Sequence
Alectinib followed by ceritinib
|
2 Participants
|
|
Number of Participants Classified According to Treatments Received for Anaplastic Lymphoma Kinase Positive-non-Small Cell Lung Cancer (ALK + NSCLC) in Sequence
Alectinib followed other
|
3 Participants
|
PRIMARY outcome
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 studyPopulation: Analysis population included all eligible participants whose data were included and observed in this study.
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.
Outcome measures
| Measure |
All Eligible Participants
n=161 Participants
Participants who were on treatment with Alectinib for ALK+ NSCLC in real world clinical practices during 01-Jun-2017 to 31-Aug-2020.
|
|---|---|
|
Number of Participants Classified According to Reason for Alectinib Treatment Discontinuation
Hospice
|
7 Participants
|
|
Number of Participants Classified According to Reason for Alectinib Treatment Discontinuation
Toxicity
|
13 Participants
|
|
Number of Participants Classified According to Reason for Alectinib Treatment Discontinuation
Death
|
15 Participants
|
|
Number of Participants Classified According to Reason for Alectinib Treatment Discontinuation
Progression
|
55 Participants
|
|
Number of Participants Classified According to Reason for Alectinib Treatment Discontinuation
Decline in performance status
|
1 Participants
|
|
Number of Participants Classified According to Reason for Alectinib Treatment Discontinuation
Participant choice
|
1 Participants
|
|
Number of Participants Classified According to Reason for Alectinib Treatment Discontinuation
Physician choice
|
1 Participants
|
|
Number of Participants Classified According to Reason for Alectinib Treatment Discontinuation
Unknown
|
3 Participants
|
|
Number of Participants Classified According to Reason for Alectinib Treatment Discontinuation
Other
|
3 Participants
|
|
Number of Participants Classified According to Reason for Alectinib Treatment Discontinuation
No evidence of alectinib discontinuation
|
68 Participants
|
PRIMARY outcome
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 studyPopulation: Analysis population included all eligible participants whose data were included and observed in this study.
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.
Outcome measures
| Measure |
All Eligible Participants
n=161 Participants
Participants who were on treatment with Alectinib for ALK+ NSCLC in real world clinical practices during 01-Jun-2017 to 31-Aug-2020.
|
|---|---|
|
Duration of Therapy (DOT)
|
23.9 Months
Interval 18.2 to 31.9
|
PRIMARY outcome
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 studyPopulation: Analysis population included all eligible participants whose data were included and observed in this study.
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.
Outcome measures
| Measure |
All Eligible Participants
n=161 Participants
Participants who were on treatment with Alectinib for ALK+ NSCLC in real world clinical practices during 01-Jun-2017 to 31-Aug-2020.
|
|---|---|
|
Overall Survival (OS)
|
46.3 Months
Interval 36.6 to
Upper limit of 95% CI could not be estimated as there were insufficient number of participants with event and hence not available to report.
|
PRIMARY outcome
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 studyPopulation: Analysis population included all eligible participants whose data were included and observed in this study.
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.
Outcome measures
| Measure |
All Eligible Participants
n=161 Participants
Participants who were on treatment with Alectinib for ALK+ NSCLC in real world clinical practices during 01-Jun-2017 to 31-Aug-2020.
|
|---|---|
|
Progression Free Survival (PFS)
|
41.4 Months
Interval 20.1 to
Upper limit of 95% CI could not be estimated as there were insufficient number of participants with event and hence not available to report.
|
Adverse Events
All Eligible Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 56 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER