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OpenTrials
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NCT Number: NCT07556549

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Non-Small Cell Lung Cancer ALK-positive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer

Beijing, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Lorlatinib

Drug

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

Primary outcomes

  1. Age at Start of Lorlatinib Treatment

    Time frame: At initiation of lorlatinib treatment between July 2022- October 2024

    Number of percentages of patients by age

  2. Smoking status (if available) at Start of Lorlatinib Treatment

    Time frame: At initiation of lorlatinib treatment between July 2022- October 2024

    Number of patients by smoking status

  3. Histology of patients at start of Lorlatinib treatment

    Time frame: At initiation of lorlatinib treatment between July 2022- October 2024

    Histology of patients were reported in this outcome measure

  4. Eastern Cooperative Oncology Group (ECOG) performance status of patients at Start of Lorlatinib Treatment

    Time frame: At initiation of lorlatinib treatment between July 2022- October 2024

    number of Eastern Cooperative Oncology Group (ECOG) performance status of patients

  5. Initial cancer stage at diagnosis of patients prior Start of Lorlatinib Treatment

    Time frame: At initiation of lorlatinib treatment between July 2022- October 2024

    initial cancer stage of patients were reported in this outcome measure

  6. Current cancer stage at Start of Lorlatinib Treatment

    Time frame: At initiation of lorlatinib treatment between July 2022- October 2024

    Current cancer stage of patients were reported in this outcome measure

  7. Brain metastases status at Start of Lorlatinib Treatment

    Time frame: At initiation of lorlatinib treatment between July 2022- October 2024

    Brain metastases status of patients were reported in this outcome measure

  8. Date of initial NSCLC diagnosis

    Time frame: At initiation of lorlatinib treatment between July 2022- October 2024

    Date of initial NSCLC diagnosis

  9. Date of a/mNSCLC diagnosis

    Time frame: At initiation of lorlatinib treatment between July 2022- October 2024

    Date of a/mNSCLC diagnosis of patients were reported in this outcome measure

  10. ALK-positive diagnosis prior to Start of Lorlatinib Treatment

    Time frame: At initiation of lorlatinib treatment between July 2022- October 2024

    Date of patients with ALK-positive diagnosis

  11. Gene testing method and results prior to initiation of lorlatinib treatment

    Time frame: At initiation of lorlatinib treatment between July 2022- October 2024

    Gene testing method and results of patients were reported in this outcome measure

  12. Date of brain metastases diagnosis prior to initiation of lorlatinib treatment

    Time frame: At initiation of lorlatinib treatment between July 2022- October 2024

    number and date of brain metastases diagnosis of patients for whom had BM prior lorlatinib treatment

  13. Presence of comorbidities at Start of Lorlatinib Treatment

    Time frame: At initiation of lorlatinib treatment between July 2022- October 2024

    Presence of comorbidities of patients were reported in this outcome measure

  14. Concomitant therapies at Start of Lorlatinib Treatment

    Time frame: At initiation of lorlatinib treatment between July 2022- October 2024

    Concomitant therapies of patients were reported in this outcome measure

  15. Date of lorlatinib initiation

    Time frame: At initiation of lorlatinib treatment between July 2022- October 2024

    Date of Lorlatinib first prescription were reported in this outcome measure

  16. Initial lorlatinib dose at Start of Lorlatinib Treatment

    Time frame: At initiation of lorlatinib treatment between July 2022- October 2024

    Initial lorlatinib dose for patients receiving Lorlatinb treatment were reported in this outcome measure

  17. Dose adjustments when patients were prescribed with Lorlatinib Treatment

    Time frame: 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).

    Dose adjustments of Lorlatinib Treatment and Date were reported in this outcome measure

  18. Gender at Start of Lorlatinib Treatment

    Time frame: At initiation of lorlatinib treatment between July 2022- October 2024

    Number of patients by gender

  19. Weight at Start of Lorlatinib Treatment

    Time frame: At initiation of lorlatinib treatment between July 2022- October 2024

    Number of patients by weight

  20. Height at Start of Lorlatinib Treatment

    Time frame: At initiation of lorlatinib treatment between July 2022- October 2024

    Number of patients by height

  21. Body mass index (BMI) at Start of Lorlatinib Treatment

    Time frame: At initiation of lorlatinib treatment between July 2022- October 2024

    Number of patients by BMI

Secondary outcomes

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

    Time frame: 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).

    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.

  2. Last dose for Patients who are still on the Lorlatinib first line treatment

    Time frame: 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).

    Last dose for Patients who are still on the therapy were reported in this outcome measure

  3. Treatment switching to other ALK TKls from Lorlatinib Treatment

    Time frame: 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 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.

  4. 1L lorlatinib resistance mechanism (if applicable)

    Time frame: 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).

    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.

  5. Treatment switching to subsequence treatment from 1L Lorlatinib Treatment

    Time frame: 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).

    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.

  6. Medical Costs during lorlatinib treatment period

    Time frame: 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).

    Medical Costs during lorlatinib treatment period for patients were reported in this outcome measure, inducing drug costs, hospitalization costs, outpatient cost, and ect.

  7. Brain metastases progression and date of patients receiving Lorlatinib treatment

    Time frame: 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).

    Brain metastases progression was radiological confirmation of new or worsening intracranial lesions.

  8. Death (if applicable) of patients receiving Lorlatinib for the first-line treatment

    Time frame: 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).

    percentage of Deaths (and date if applicable) of patients

  9. The cumulative incidence rate of BM of patients receiving Lorlatinib for the first-line treatment

    Time frame: 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).

    Percentage of number of patients with BM

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

RETROSPECTIVE CHART REVIEW STUDY OF FIRST LINE LORLATINIB IN LOCALLY ADVANCED/METASTATIC ALK-POSITIVE NON-SMALL CELL LUNG CANCER PATIENTS IN CHINA

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 29, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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