Non-Small-Cell Lung CarcinomaNCT04351334

Anaplastic Lymphoma Kinase (ALK)-Positive Non-small Cell Lung Cancer (NSCLC) Post-alectinib Treatment Patterns

An observational study of Non-Small-Cell Lung Carcinoma, run by Pfizer at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Non-Small-Cell Lung Carcinoma
What is being tested?: Alectinib
How many people: 161 participants
Where: 1 siteUnited States
Study dates: 1 Mar 2020to 1 Nov 2022
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: The study population will consist of patients with a diagnosis of NSCLC receiving alectinib.

Who may be able to join

Patients with a documented diagnosis of NSCLC.
Patients ≥ 18 years of age at initial recorded diagnosis of NSCLC.
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.
During the study observation period, patients observed with at least 2 visits after the index date-1.

Who cannot join

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.
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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Pfizer Inc
New York, New York, 10017

Other trials in United States

About this study

Official title: Patient Profiles and Treatment Patterns Among ALK-positive NSCLC Patients Treated With Alectinib

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.

Conditions: Non-Small-Cell Lung Carcinoma
Being tested: Alectinib
Medical subject headings: Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AlectinibDrug
Observational treatment based on physician choice

Study groups in NCT04351334
Study group	Role	What they receive
Patients with ALK-positive NSCLC		Not described Receives: Drug: Alectinib

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 20201 Nov 2022

First posted17 Apr 2020
Study start1 Mar 2020
Primary completion1 Nov 2022
Study completion1 Nov 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Non-Small-Cell Lung CarcinomaStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Retrospective
Enrolment: 161 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04351334
Sponsor's protocol ID: B7461031
Status last verified: May 2024
First submitted: 15 Apr 2020
Last updated: 19 Sep 2024
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: No: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Non-Small-Cell Lung Carcinoma trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Patient Profiles and Treatment Patterns Among ALK-positive NSCLC Patients Treated With Alectinib
ClinicalTrials.gov ID: NCT04351334
Acronym / sponsor ID: B7461031
Conditions: Non-Small-Cell Lung Carcinoma
Study type: Observational
Recruitment status: Completed
Enrolment: 161 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 1 Mar 2020 (actual)
Primary completion: 1 Nov 2022 (actual)
Study completion: 1 Nov 2022 (actual)
First posted: 17 Apr 2020 (actual)
Results: Posted 19 Sep 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Observational model: Case only
Time perspective: Retrospective
Number of arms: 1

Arm	Type	Receives
Patients with ALK-positive NSCLC	–	Drug: Alectinib

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: The study population will consist of patients with a diagnosis of NSCLC receiving alectinib.

Key inclusion criteria (4 listed)

Patients with a documented diagnosis of NSCLC.
Patients ≥ 18 years of age at initial recorded diagnosis of NSCLC.
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.
During the study observation period, patients observed with at least 2 visits after the index date-1.

Key exclusion criteria (2 listed)

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.
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AlectinibObservational treatment based on physician choice	Drug	Patients with ALK-positive NSCLC

Primary outcome

Number of Participants Classified According to Treatments Received for Anaplastic Lymphoma Kinase Positive-non-Small Cell Lung Cancer (ALK + NSCLC) in Sequence
Time frame: 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 ALK-TKI treatment patterns or sequencing were reported in this outcome measure.
Number of Participants Classified According to Reason for Alectinib Treatment Discontinuation
Time frame: 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
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.
Duration of Therapy (DOT)
Time frame: 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
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.
Overall Survival (OS)
Time frame: 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
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.
Progression Free Survival (PFS)
Time frame: 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
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.

Results and safety

Results posted to the registry on 19 Sep 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Eligible Participants	161	161

Primary outcome: Number of Participants Classified According to Treatments Received for Anaplastic Lymphoma Kinase Positive-non-Small Cell Lung Cancer (ALK + NSCLC) in Sequence

Time frame: 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. Count of participants. Unit: Participants

Measure	All Eligible Participants n = 161
Alectinib only	103
Alectinib followed by chemotherapy	8
Alectinib followed by lorlatinib	23
Alectinib followed by crizotinib	1
Alectinib followed by immunotherapy	2
Alectinib followed by brigatinib	15
Alectinib followed by chemoimmunotherapy	4
Alectinib followed by ceritinib	2

Population analysed: Analysis population included all eligible participants whose data were included and observed in this study.

Primary outcome: Number of Participants Classified According to Reason for Alectinib Treatment Discontinuation

Time frame: 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. Count of participants. Unit: Participants

Measure	All Eligible Participants n = 161
Hospice	7
Toxicity	13
Death	15
Progression	55
Decline in performance status	1
Participant choice	1
Physician choice	1
Unknown	3

Population analysed: Analysis population included all eligible participants whose data were included and observed in this study.

Primary outcome: Duration of Therapy (DOT)

Time frame: 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. Median (95% Confidence Interval). Unit: Months

Measure	All Eligible Participants n = 161
Value	23.9 (18.2 to 31.9)

Population analysed: Analysis population included all eligible participants whose data were included and observed in this study.

Primary outcome: Overall Survival (OS)

Time frame: 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. Median (95% Confidence Interval). Unit: Months

Measure	All Eligible Participants n = 161
Value	46.3 (36.6 to NA)

Population analysed: Analysis population included all eligible participants whose data were included and observed in this study.

Adverse events

Time frame: 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. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Eligible Participants	0 of 0	0 of 0	56 of 161

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: No. 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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A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Non-Small-Cell Lung Carcinoma, run by Pfizer at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Classified According to Treatments Received for Anaplastic Lymphoma Kinase Positive-non-Small Cell Lung Cancer (ALK + NSCLC) in Sequence (time frame: 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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04351334.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.