A Study to Learn About Lorlatinib in Patients With Non-Small Cell Lung Cancer Which Could Not Be Controlled

NCT06282991 | Completed Results

• 2 other identifiers: B7461028NCT06282991
• Study Type: observational
• Target: 73
• Locations: 1 country
• Sites: 6

Brief Summary

The purpose of this study is to learn about lorlatinib for the possible treatment of lung cancer which could not be controlled. This study is seeking participants who:

• have lung cancer that could not be controlled.
• have a type of gene called anaplastic lymphoma kinase. A gene is a part of your DNA that has instructions for making things your body needs to work.
• have received at least 1 treatment before. All participants in this study had received lorlatinib. Lorlatinib is a tablet that is taken by mouth at home. They continued to take dacomitinib until their cancer was no longer responding. The study will look at the experiences of people receiving the study medicine. This will help to see if the study medicine is safe and effective.

Conditions

Non-Small Cell Lung Carcinoma

Keywords

ALK; TKI; Lorlatinib; RWE

Outcome Measures

Primary Outcomes (11)

• Number of Participants According to First Line Therapy Treatment Pattern From Initial Diagnosis to Current Lorlatinib Treatment

  Number of participants according to first line therapy treatment pattern was reported in this outcome measure.

  Baseline; data retrieved from medical records and observed in this study for approximately 5 months and 28 days

• Objective Response Rate (ORR) During Lorlatinib Treatment

  ORR was defined as the percentage of participants in whom complete response (CR), or partial response (PR) was observed. According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1: 1) CR is defined as disappearance of all target lesions or partial response (PR) defined as \>=30 percent (%) decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD .

  From first dose of lorlatinib until 30 Sep 2020 or death whichever occurred first (maximum up to 41.1 months); data retrieved from medical records and observed in this study for approximately 5 months and 28 days

• Overall Survival

  Overall survival was defined as the time from the date of first dose of lorlatinib to the date of death, censored at the participant's last contact date or the data cutoff date, whichever was earlier. Overall survival was evaluated using Kaplan-Meier method.

  From first dose of lorlatinib until date of death or censoring date (maximum up to 41.1 months); data retrieved from medical records and observed in this study for approximately 5 months and 28 days

• Progression Free Survival (PFS) For Lorlatinib Treatment

  PFS refers to the duration from the first study treatment of Lorlatinib to the first documentation of disease progression or death or censored date. According to RECIST, progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The appearance of one or more new lesions is also considered progression. PFS was evaluated using the Kaplan-Meier method.

  From first dose of lorlatinib until date of death or censoring date (maximum up to 41.1 months); data retrieved from medical records and observed in this study for approximately 5 months and 28 days

• 1-year OS Rate on Lorlatinib

  OS was defined as the time from the date of first dose of lorlatinib to the date of death, censored at the participant's last contact date or the data cutoff date, whichever was earlier. In this outcome measure percentage of participants who survived for 1 year are reported.

  1 year; data retrieved from medical records and observed in this study for approximately 5 months and 28 days

• Time to Treatment Failure (TTF) for All NSCLC Treatment

  TTF was defined as duration of first dose of any NSCLC treatment to treatment failure (defined as any discontinuation, including cancer progression, adverse events, or death).

  From date of first dose of NSCLC treatment until treatment failure (maximum up to 41.1 months); data retrieved from medical records and observed in this study for approximately 5 months and 28 days

• TTF for Lorlatinib Treatment Failure

  TTF was defined as duration of first dose of lorlatinib treatment to treatment failure (any discontinuation, including cancer progression, adverse events, or death).

  From date of first dose of lorlatinib until end of study (maximum up to 41.1 months); data retrieved from medical records and observed in this study for approximately 5 months and 28 days

• Number of Participants With Common Adverse Drug Reaction (ADRs)

  An ADR is defined as all noxious and unintended responses to a medicinal product related to any dose. Common ADRs were hyperlipidemia, hyperglycemia, rash \& itch, mental disorder, edema, body weight gain, transaminase level escalation, peripheral neuropathy, thrombocytopenia, gastrointestinal disorder, creatine kinase increased, dizziness and pneumonitis. Lorlatinib related ADR was recorded from first dose of Lorlatinib until end of study.

  From date of first dose of lorlatinib until end of study (maximum up to 41.1 months); data retrieved from medical records and observed in this study for approximately 5 months and 28 days

• Duration of Common ADRs

  An ADR is defined as all noxious and unintended responses to a medicinal product related to any dose. Common ADRs were hyperlipidemia, hyperglycemia, rash \& itch, mental disorder, edema, body weight gain, transaminase level escalation, peripheral neuropathy and others (thrombocytopenia, gastrointestinal disorder, creatine kinase increased, dizziness, pneumonitis). Lorlatinib related ADR was recorded from first dose of Lorlatinib until end of study. Duration of common ADR is reported in this outcome measure.

  From date of first dose of lorlatinib until end of study (maximum up to 41.1 months); data retrieved from medical records and observed in this study for approximately 5 months and 28 days

• Number of Participants According to Severity of Common ADRs

  An ADR is defined as all noxious and unintended responses to a medicinal product related to any dose. Number of participants with Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (life-threatening) and Unknown were presented in this outcome measure. Severity grades were assessed upon investigator's discretion, wherein grade 1 was minimum severity and grade 4 was maximum severity.

  From date of first dose of lorlatinib until end of study (maximum up to 41.1 months); data retrieved from medical records and observed in this study for approximately 5 months and 28 days

• Number of Participants According to Type of Outcome of Common ADRs

  An ADR is defined as all noxious and unintended responses to a medicinal product related to any dose. Participants were categorized as per their ADRs outcome as: recovered, recovered with sequelae (Sequelae refer to any complication or condition that results from a pre-existing illness, injury, or medical intervention), recovering, not recovered, and unknown.

  From date of first dose of lorlatinib until end of study (maximum up to 41.1 months); data retrieved from medical records and observed in this study for approximately 5 months and 28 days

Study Arms (1)

Lorlatinib

Patients received lorlatinib treatment under EAP

Drug: Lorlatinib

Interventions

Lorlatinib DRUG

ALK/ROS1 tyrosine kinase inhibitor

Also known as: PF-6463992

Lorlatinib

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All subjects will be enrolled from Lorlatinib Compassionate Use Program (CUP) and should be entered into this observational study at the physician's discretion.

You may qualify if:

• Age ≥ 20 years old
• Patients who were approved to join Lorlatinib CUP on or before 31 Jul 2019 while initiate Lorlatinib treatment before 30 Sep 2019,
• Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

You may not qualify if:

• Patient treated Lorlatinib other than CUP.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (6)

CHANG GUNG MEMORIAL HOSPITAL Kaohsiung Branch

Kaohsiung City, 83301, Taiwan

Location

Chung Shan Medical University Hospital

Taichung, 402, Taiwan

Location

Taichung Veterans General Hospital

Taichung, 407219, Taiwan

Location

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

Chang Gung Memorial Hospital - Linkou Branch

Taoyuan, 333, Taiwan

Location

Related Links

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

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

lorlatinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: February 28, 2024
• Study Start: July 22, 2020
• Primary Completion: January 18, 2021
• Study Completion: January 18, 2021
• Last Updated: March 10, 2026
• Results First Posted: March 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (6)