A Study to Learn About Study Medicine Lorlatinib, as a First-line Treatment in Chinese Adults With ALK-positive a/mNSCLC

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Non-Small Cell Lung Cancer ALK-positive
• Intervention / Treatment: Drug: Lorlatinib

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Pfizer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Chinese adult patients who were diagnosed with ALK-positive a/mNSCLC, and initiated lorlatinib as first line treatment

Description

Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:

1. Age ≥18 years
2. Diagnosed with a/mNSCLC
3. Confirmed testing for ALK-positive
4. Initiated first-line lorlatinib treatment during the patient selection period, prior therapy such as adjuvant or neoadjuvant treatment are allowed.
5. A minimum lookback period of at least 3 months to establish a baseline period and ensure first-line use of cohort entry drug
6. Have at least 6 months of follow-up data available (early death or progression will be included)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Lorlatinib in locally advanced/metastatic ALK-positive Non-Small Cell Lung Cancer Patients in China	Drug: Lorlatinib; for the treatment of patients with locally advanced or metastatic ALK positive non-small cell lung cancer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age at Start of Lorlatinib Treatment	Number of percentages of patients by age	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	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	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	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	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	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	At initiation of lorlatinib treatment between July 2022- October 2024
Date of initial NSCLC diagnosis	Date of initial NSCLC diagnosis	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	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	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	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	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	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	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	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	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	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	At initiation of lorlatinib treatment between July 2022- October 2024
Weight at Start of Lorlatinib Treatment	Number of patients by weight	At initiation of lorlatinib treatment between July 2022- October 2024
Height at Start of Lorlatinib Treatment	Number of patients by height	At initiation of lorlatinib treatment between July 2022- October 2024
Body mass index (BMI) at Start of Lorlatinib Treatment	Number of patients by BMI	At initiation of lorlatinib treatment between July 2022- October 2024

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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.	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).
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.	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.	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.	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	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	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).
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.	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).

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: April 7, 2026
• First Submitted That Met QC Criteria: April 24, 2026
• First Posted (Actual): April 29, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: lorlatinib
• Other Study ID Numbers: B7461056

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No