Non-Small Cell Lung Cancer ALK-positiveNCT07556549
A Study to Learn About Study Medicine Lorlatinib, as a First-line Treatment in Chinese Adults With ALK-positive a/mNSCLC
An observational study of Non-Small Cell Lung Cancer ALK-positive, run by Pfizer at 1 site in China.
Trial summary
The purpose of this retrospective study is to learn about the real-world effects of the study medicine lorlatinib for the first-line treatment of Chinese adult patients who were diagnosed with ALK-positive a/mNSCLC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer ALK-positive
- What is being tested?
- Lorlatinib
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 18 May 2026to 30 Aug 2026
- Phase
- Observational
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: Chinese adult patients who were diagnosed with ALK-positive a/mNSCLC, and initiated lorlatinib as first line treatment
Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
- Age ≥18 years
- Diagnosed with a/mNSCLC
- Confirmed testing for ALK-positive
- Initiated first-line lorlatinib treatment during the patient selection period, prior therapy such as adjuvant or neoadjuvant treatment are allowed.
- A minimum lookback period of at least 3 months to establish a baseline period and ensure first-line use of cohort entry drug
- Have at least 6 months of follow-up data available (early death or progression will be included)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: RETROSPECTIVE CHART REVIEW STUDY OF FIRST LINE LORLATINIB IN LOCALLY ADVANCED/METASTATIC ALK-POSITIVE NON-SMALL CELL LUNG CANCER PATIENTS IN CHINA
The purpose of this retrospective study is to learn about the real-world effects of the study medicine lorlatinib for the first-line treatment of Chinese adult patients who were diagnosed with ALK-positive a/mNSCLC.
The participants included in this study are:
- Aged 18 years or more
- diagnosed with a/mNSCLC
- confirmed with testing for ALK-positive
- have started first-line lorlatinib treatment during the patient selection period
In this study, the main objectives are to learn the patient characteristics and the real-world treatment pattern of first-line treatment of lorlatinib in China at a real-world setting.
- Conditions
- Non-Small Cell Lung Cancer ALK-positive
- Being tested
- Lorlatinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LorlatinibDrug
for the treatment of patients with locally advanced or metastatic ALK positive non-small cell lung cancer.
| Study group | Role | What they receive |
|---|---|---|
| Lorlatinib in locally advanced/metastatic ALK-positive Non-Small Cell Lung Cancer Patients in China | Not described Receives: Drug: Lorlatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Age at Start of Lorlatinib Treatment
Number of percentages of patients by age
Measured: At initiation of lorlatinib treatment between July 2022- October 2024
Smoking status (if available) at Start of Lorlatinib Treatment
Number of patients by smoking status
Measured: At initiation of lorlatinib treatment between July 2022- October 2024
Histology of patients at start of Lorlatinib treatment
Histology of patients were reported in this outcome measure
Measured: At initiation of lorlatinib treatment between July 2022- October 2024
Eastern Cooperative Oncology Group (ECOG) performance status of patients at Start of Lorlatinib Treatment
number of Eastern Cooperative Oncology Group (ECOG) performance status of patients
Measured: At initiation of lorlatinib treatment between July 2022- October 2024
Initial cancer stage at diagnosis of patients prior Start of Lorlatinib Treatment
initial cancer stage of patients were reported in this outcome measure
Measured: At initiation of lorlatinib treatment between July 2022- October 2024
Current cancer stage at Start of Lorlatinib Treatment
Current cancer stage of patients were reported in this outcome measure
Measured: At initiation of lorlatinib treatment between July 2022- October 2024
Brain metastases status at Start of Lorlatinib Treatment
Brain metastases status of patients were reported in this outcome measure
Measured: At initiation of lorlatinib treatment between July 2022- October 2024
Date of initial NSCLC diagnosis
Date of initial NSCLC diagnosis
Measured: At initiation of lorlatinib treatment between July 2022- October 2024
Date of a/mNSCLC diagnosis
Date of a/mNSCLC diagnosis of patients were reported in this outcome measure
Measured: At initiation of lorlatinib treatment between July 2022- October 2024
ALK-positive diagnosis prior to Start of Lorlatinib Treatment
Date of patients with ALK-positive diagnosis
Measured: At initiation of lorlatinib treatment between July 2022- October 2024
Gene testing method and results prior to initiation of lorlatinib treatment
Gene testing method and results of patients were reported in this outcome measure
Measured: At initiation of lorlatinib treatment between July 2022- October 2024
Date of brain metastases diagnosis prior to initiation of lorlatinib treatment
number and date of brain metastases diagnosis of patients for whom had BM prior lorlatinib treatment
Measured: At initiation of lorlatinib treatment between July 2022- October 2024
Presence of comorbidities at Start of Lorlatinib Treatment
Presence of comorbidities of patients were reported in this outcome measure
Measured: At initiation of lorlatinib treatment between July 2022- October 2024
Concomitant therapies at Start of Lorlatinib Treatment
Concomitant therapies of patients were reported in this outcome measure
Measured: At initiation of lorlatinib treatment between July 2022- October 2024
Date of lorlatinib initiation
Date of Lorlatinib first prescription were reported in this outcome measure
Measured: At initiation of lorlatinib treatment between July 2022- October 2024
Initial lorlatinib dose at Start of Lorlatinib Treatment
Initial lorlatinib dose for patients receiving Lorlatinb treatment were reported in this outcome measure
Measured: At initiation of lorlatinib treatment between July 2022- October 2024
Dose adjustments when patients were prescribed with Lorlatinib Treatment
Dose adjustments of Lorlatinib Treatment and Date were reported in this outcome measure
Measured: From the date of initiation of lorlatinib treatment to the date of treatment dose adjustments, assessed up to 50 months (where 50 months is the estimated maximum follow-up duration for this outcome).
Gender at Start of Lorlatinib Treatment
Number of patients by gender
Measured: At initiation of lorlatinib treatment between July 2022- October 2024
Weight at Start of Lorlatinib Treatment
Number of patients by weight
Measured: At initiation of lorlatinib treatment between July 2022- October 2024
Height at Start of Lorlatinib Treatment
Number of patients by height
Measured: At initiation of lorlatinib treatment between July 2022- October 2024
Body mass index (BMI) at Start of Lorlatinib Treatment
Number of patients by BMI
Measured: At initiation of lorlatinib treatment between July 2022- October 2024
Secondary outcomes (9)
Time to Discontinuation (TTD) in 1 L lorlatinib patients
Time to Discontinuation (TTD) was the time from the date of initiation of Lorlatinib Treatment to date if the permanent cessation of lorlatinib due to any reasons, including progression, adverse events, patient decision, or physician recommendation. TTD will be analyzed using Kaplan-Meier survival analysis.
Measured: From the date of first lorlatinib dose until permanent discontinuation of treatment for any cause, assessed up to 50 months (where 50 months is the estimated maximum follow-up duration for this outcome).
Last dose for Patients who are still on the Lorlatinib first line treatment
Last dose for Patients who are still on the therapy were reported in this outcome measure
Measured: the date of any-cause treatment discontinuation or study end, assessed up to 50 months (where 50 months is the estimated maximum follow-up duration for this outcome).
Treatment switching to other ALK TKls from Lorlatinib Treatment
Treatment switching to other ALK TKls was switching from lorlatinib to another ALK-TKIs due to any reasons. The Name of treatment regimen, Date of treatment switch and Duration of each switched regimen were recorded in this outcome measure.
Measured: From the date of initiation of other ALK TKIs to the study end, assessed up to 50 months (where 50 months is the estimated maximum follow-up duration for this outcome).
1L lorlatinib resistance mechanism (if applicable)
Characterization of acquired resistance mechanisms to first-line lorlatinib, including on-target ALK alterations and off-target/bypass pathway activations, as identified at disease progression.
Measured: From the date of initiation of lorlatinib treatment to the date of any-cause treatment discontinuation or study end, assessed up to 50 months (where 50 months is the estimated maximum follow-up duration for this outcome).
Treatment switching to subsequence treatment from 1L Lorlatinib Treatment
Treatment switching to subsequence treatment was switching from lorlatinib to another systemic therapy due to treatment failure caused by progression, intolerance, or physician decision. It was recorded in this outcome measure.
Measured: From the date of initiation of subsequent other treatment to the date of any-cause treatment discontinuation or study end, assessed up to 50 months (where 50 months is the estimated maximum follow-up duration for this outcome).
Medical Costs during lorlatinib treatment period
Medical Costs during lorlatinib treatment period for patients were reported in this outcome measure, inducing drug costs, hospitalization costs, outpatient cost, and ect.
Measured: From the date of first lorlatinib dose until permanent discontinuation of treatment for any cause, assessed up to 50 months (where 50 months is the estimated maximum follow-up duration for this outcome).
Brain metastases progression and date of patients receiving Lorlatinib treatment
Brain metastases progression was radiological confirmation of new or worsening intracranial lesions.
Measured: From the date of initiation of lorlatinib treatment to the date of BM progression, assessed up to 50 months (where 50 months is the estimated maximum follow-up duration for this outcome).
Death (if applicable) of patients receiving Lorlatinib for the first-line treatment
percentage of Deaths (and date if applicable) of patients
Measured: From the date of initiation of lorlatinib treatment to the date of any-cause treatment discontinuation or study end, assessed up to 50 months (where 50 months is the estimated maximum follow-up duration for this outcome).
The cumulative incidence rate of BM of patients receiving Lorlatinib for the first-line treatment
Percentage of number of patients with BM
Measured: From the date of initiation of lorlatinib treatment to the date of any-cause treatment discontinuation or study end, assessed up to 50 months (where 50 months is the estimated maximum follow-up duration for this outcome).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start18 May 2026
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Aug 2026 (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 Lung Cancer ALK-positiveStudies 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
- 50 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
- NCT07556549
- Sponsor's protocol ID
- B7461056
- Status last verified
- Aug 2026
- First submitted
- 7 Apr 2026
- Last updated
- 10 Aug 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.