Non-Small-Cell LungNCT07567352
A Study to Learn About Patients With Non-Small Cell Lung Cancer (NSCLC) Who Took Lorlatinib as Their First Treatment
An observational study of Non-Small-Cell Lung and ALK-positive Advanced NSCLC, run by Pfizer at 1 site in United States.
Trial summary
The main purpose of the study is to learn how the lung cancer medicines work. The study also looks into treatment sequence of these medicines. This study is performed outside of clinical studies in a database in the United States in patients with metastatic or advanced non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small-Cell Lung, ALK-positive Advanced NSCLC, ALK-positive Non-small-cell Lung Cancer
- What is being tested?
- lorlatinib
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2026to 1 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 are patients with advanced/metastatic non-small cell lung cancer in Flatiron Health's Advanced NSCLC Panoramic dataset.
Who may be able to join
- Positive for ALK rearrangement
- 18 years or older at advanced/metastatic NSCLC diagnosis date
- Initiated 1L lorlatinib in the metastatic/advanced setting between 3 March 2021 and latest data cutoff available
Who cannot join
- Missing ALK rearrangement status
- Use of alectinib in the adjuvant setting
- Use of lorlatinib in a clinical trial setting
Trial locations and contacts
1 site in 1 country.
About this study
Official title: LONGITUDINAL REAL-WORLD STUDY OF FIRST-LINE (1L) LORLATINIB IN THE UNITED STATES: PERFORMANCE STATUS AND TREATMENT PATTERNS
The main purpose of the study is to learn how the lung cancer medicines work. The study also looks into treatment sequence of these medicines. This study is performed outside of clinical studies in a database in the United States in patients with metastatic or advanced non-small cell lung cancer. Non-small cell lung cancer is a group of lung cancers named for the kinds of cells found in the cancer and how the cells look under a microscope. Metastasis is when the cancer cells spread to other parts of the body. Advanced cancer is when the patient is diagnosed with stage III or stage IV cancer.
This study includes patient's information from the database who:
Read more
- Are aged 18 years or older.
- Are confirmed to have metastatic non-small cell lung cancer on or after 1 January 2021.
- Have a positive Anaplastic Lymphoma Kinase (ALK) gene mutation or rearrangement. A gene is a part of your DNA that has instructions for making things your body needs to work and a mutation or rearrangement can cause the gene not to work properly. ALK is a protein that helps control cell growth.
- Received lorlatinib as their first treatment.
All participants in this study had received the study medicine lorlatinib. It is a tablet that is taken by mouth at home. They continued to take the study medicine until their cancer was no longer responding. The study will look at the experiences of people receiving the study medicine.
The study is based on information collected from Flatiron Health's Advanced NSCLC Panoramic dataset which includes:
- Diagnosis, cancer stage at diagnosis, date of diagnosis, birth year, type of medicinal treatment, date of treatment start and end, age, gender, etc.
Read the detailed description
Non-small cell lung cancer (NSCLC) accounts for approximately 85% of all lung cancer diagnoses worldwide, most often diagnosed in advanced stages. Targeted drugs are currently the most often used therapies for advanced NSCLC patients that harbor rearrangements in the anaplastic lymphoma kinase (ALK) gene, defining a distinct molecular subtype with unique therapeutic considerations. The development of ALK targeted tyrosine kinase inhibitors (TKIs) has substantially improved outcomes for patients with advanced or metastatic NSCLC with these genetic variants. Lorlatinib, a third-generation inhibitor, is a potent TKI that is effective resistance to first- and second-generation ALK-TKIs. Based on the results of the pivotal phase III clinical trial, lorlatinib received regulatory approval for first line treatment of ALK positive metastatic NSCLC on 3 March 2021, establishing it as an important treatment option in routine clinical practice.
While randomized clinical trials provide critical evidence of efficacy and safety under controlled conditions, patients treated in real world settings may differ from trial populations with respect to baseline characteristics, comorbidities, treatment sequencing, and clinical management. Data describing duration of therapy and frequency of dose modifications as well as other clinical characteristics such as Eastern Cooperative Oncology Group (ECOG) performance status over time would help to elucidate the patient experience in the real-world as a first step while longer durations of follow-up time continue to accumulate.
The objective of this non-interventional study is to generate real-world evidence (RWE) characterizing 1L lorlatinib use among adults in the United States (US) using routinely collected electronic health record (EHR) data. This is a retrospective longitudinal cohort study of patients diagnosed with advanced/metastatic NSCLC with an ALK rearrangement treated with 1L lorlatinib after its approval on 3 March 2021 in the United States.
- Conditions
- Non-Small-Cell Lung, ALK-positive Advanced NSCLC, ALK-positive Non-small-cell Lung Cancer, ALK-positive NSCLC
- Being tested
- lorlatinib
- Keywords
- alk-positive, advanced lung cancer, metastatic lung cancer, non-small-cell lung cancer, lung cancer
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lorlatinibDrug
Also called Lorbrena
As provided in real world practice
| Study group | Role | What they receive |
|---|---|---|
| Advanced/metastatic non-small cell lung cancer patients | Cohort of advanced/metastatic non-small cell lung cancer patients in Flatiron Health's Advanced NSCLC Panoramic dataset. Receives: Drug: lorlatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Treatment Duration of 1L Lorlatinib
Measured: From treatment initiation (on or after 3 March 2021) to end of follow-up (date of death or EHR activity end date) (data cutoff 31 March 2026)
Time to Discontinuation of 1L Lorlatinib
Measured: From treatment initiation (on or after 3 March 2021) to end of follow-up (date of death or EHR activity end date) (data cutoff 31 March 2026)
Number of Dose Changes of 1L Lorlatinib
Measured: From treatment initiation (on or after 3 March 2021) to end of follow-up (date of death or EHR activity end date) (data cutoff 31 March 2026)
Rate of Discontinuation of 1L Lorlatinib
Measured: From treatment initiation (on or after 3 March 2021) to end of follow-up (date of death or EHR activity end date) (data cutoff 31 March 2026)
Time to next treatment (TTNT)
Measured: From treatment initiation (on or after 3 March 2021) to end of follow-up (date of death or EHR activity end date) (data cutoff 31 March 2026)
Clinical Characteristic of Participants: Eastern Cooperative Oncology Group (ECOG) Performance Status
Measured: From treatment initiation (on or after 3 March 2021) to end of follow-up (date of death or EHR activity end date) (data cutoff 31 March 2026)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study start1 May 2026
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small-Cell LungStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07567352
- Sponsor's protocol ID
- B7461064
- Status last verified
- Sep 2026
- First submitted
- 28 Apr 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LONGITUDINAL REAL-WORLD STUDY OF FIRST-LINE (1L) LORLATINIB IN THE UNITED STATES: PERFORMANCE STATUS AND TREATMENT PATTERNS
- ClinicalTrials.gov ID
- NCT07567352
- Acronym / sponsor ID
- B7461064
- Conditions
- Non-Small-Cell Lung, ALK-positive Advanced NSCLC, ALK-positive Non-small-cell Lung Cancer, ALK-positive NSCLC
- Keywords
- alk-positive, advanced lung cancer, metastatic lung cancer, non-small-cell lung cancer, lung cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 1 May 2026 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 5 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of the study is to learn how the lung cancer medicines work. The study also looks into treatment sequence of these medicines. This study is performed outside of clinical studies in a database in the United States in patients with metastatic or advanced non-small cell lung cancer. Non-small cell lung cancer is a group of lung cancers named for the kinds of cells found in the cancer and how the cells look under a microscope. Metastasis is when the cancer cells spread to other parts of the body. Advanced cancer is when the patient is diagnosed with stage III or stage IV cancer.
This study includes patient's information from the database who:
- Are aged 18 years or older.
- Are confirmed to have metastatic non-small cell lung cancer on or after 1 January 2021.
- Have a positive Anaplastic Lymphoma Kinase (ALK) gene mutation or rearrangement. A gene is a part of your DNA that has instructions for making things your body needs to work and a mutation or rearrangement can cause the gene not to work properly. ALK is a protein that helps control cell growth.
- Received lorlatinib as their first treatment.
All participants in this study had received the study medicine lorlatinib. It is a tablet that is taken by mouth at home. They continued to take the study medicine until their cancer was no longer responding. The study will look at the experiences of people receiving the study medicine.
The study is based on information collected from Flatiron Health's Advanced NSCLC Panoramic dataset which includes:
- Diagnosis, cancer stage at diagnosis, date of diagnosis, birth year, type of medicinal treatment, date of treatment start and end, age, gender, etc.
Detailed description
Non-small cell lung cancer (NSCLC) accounts for approximately 85% of all lung cancer diagnoses worldwide, most often diagnosed in advanced stages. Targeted drugs are currently the most often used therapies for advanced NSCLC patients that harbor rearrangements in the anaplastic lymphoma kinase (ALK) gene, defining a distinct molecular subtype with unique therapeutic considerations. The development of ALK targeted tyrosine kinase inhibitors (TKIs) has substantially improved outcomes for patients with advanced or metastatic NSCLC with these genetic variants. Lorlatinib, a third-generation inhibitor, is a potent TKI that is effective resistance to first- and second-generation ALK-TKIs. Based on the results of the pivotal phase III clinical trial, lorlatinib received regulatory approval for first line treatment of ALK positive metastatic NSCLC on 3 March 2021, establishing it as an important treatment option in routine clinical practice.
While randomized clinical trials provide critical evidence of efficacy and safety under controlled conditions, patients treated in real world settings may differ from trial populations with respect to baseline characteristics, comorbidities, treatment sequencing, and clinical management. Data describing duration of therapy and frequency of dose modifications as well as other clinical characteristics such as Eastern Cooperative Oncology Group (ECOG) performance status over time would help to elucidate the patient experience in the real-world as a first step while longer durations of follow-up time continue to accumulate.
The objective of this non-interventional study is to generate real-world evidence (RWE) characterizing 1L lorlatinib use among adults in the United States (US) using routinely collected electronic health record (EHR) data. This is a retrospective longitudinal cohort study of patients diagnosed with advanced/metastatic NSCLC with an ALK rearrangement treated with 1L lorlatinib after its approval on 3 March 2021 in the United States.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Advanced/metastatic non-small cell lung cancer patients | – | Drug: lorlatinibCohort of advanced/metastatic non-small cell lung cancer patients in Flatiron Health's Advanced NSCLC Panoramic dataset. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population are patients with advanced/metastatic non-small cell lung cancer in Flatiron Health's Advanced NSCLC Panoramic dataset.
Key inclusion criteria (3 listed)
- Positive for ALK rearrangement
- 18 years or older at advanced/metastatic NSCLC diagnosis date
- Initiated 1L lorlatinib in the metastatic/advanced setting between 3 March 2021 and latest data cutoff available
Key exclusion criteria (3 listed)
- Missing ALK rearrangement status
- Use of alectinib in the adjuvant setting
- Use of lorlatinib in a clinical trial setting
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 |
|---|---|---|
| lorlatinibAlso: LorbrenaAs provided in real world practice | Drug | Advanced/metastatic non-small cell lung cancer patients |
Primary outcome
Overall Treatment Duration of 1L Lorlatinib
Time frame: From treatment initiation (on or after 3 March 2021) to end of follow-up (date of death or EHR activity end date) (data cutoff 31 March 2026)
Time to Discontinuation of 1L Lorlatinib
Time frame: From treatment initiation (on or after 3 March 2021) to end of follow-up (date of death or EHR activity end date) (data cutoff 31 March 2026)
Number of Dose Changes of 1L Lorlatinib
Time frame: From treatment initiation (on or after 3 March 2021) to end of follow-up (date of death or EHR activity end date) (data cutoff 31 March 2026)
Rate of Discontinuation of 1L Lorlatinib
Time frame: From treatment initiation (on or after 3 March 2021) to end of follow-up (date of death or EHR activity end date) (data cutoff 31 March 2026)
Time to next treatment (TTNT)
Time frame: From treatment initiation (on or after 3 March 2021) to end of follow-up (date of death or EHR activity end date) (data cutoff 31 March 2026)
Clinical Characteristic of Participants: Eastern Cooperative Oncology Group (ECOG) Performance Status
Time frame: From treatment initiation (on or after 3 March 2021) to end of follow-up (date of death or EHR activity end date) (data cutoff 31 March 2026)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- 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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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 and ALK-positive Advanced NSCLC, 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 3 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 17 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Overall Treatment Duration of 1L Lorlatinib (time frame: From treatment initiation (on or after 3 March 2021) to end of follow-up (date of death or EHR activity end date) (data cutoff 31 March 2026)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Sep 2026.