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

NCT07556549 | Not Yet Recruiting FDA Drug

• 1 other identifier: B7461056
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Outcome Measures

Primary Outcomes (21)

• 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 Outcomes (9)

• Time to Discontinuation (TTD) in 1 L lorlatinib patients

  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

  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

  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)

  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

  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).

Study Arms (1)

Lorlatinib in locally advanced/metastatic ALK-positive Non-Small Cell Lung Cancer Patients in China

Drug: Lorlatinib

Interventions

Lorlatinib DRUG

for the treatment of patients with locally advanced or metastatic ALK positive non-small cell lung cancer.

Lorlatinib in locally advanced/metastatic ALK-positive Non-Small Cell Lung Cancer Patients in China

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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)

Sponsors & Collaborators

• Pfizer: lead

Related Links

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

MeSH Terms

Interventions

lorlatinib

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021; ClinicalTrials.gov_Inquiries@pfizer.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 29, 2026
• Study Start: April 20, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share