A Study to Learn About Patients With Non-Small Cell Lung Cancer (NSCLC) Who Took Lorlatinib as Their First Treatment

NCT07567352 | Not Yet Recruiting FDA Drug

• 1 other identifier: B7461064
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

The main purpose of the study is to learn how the lung cancer medicines work. The study also looks into treatment sequence of these medicines. This study is performed outside of clinical studies in a database in the United States in patients with metastatic or advanced non-small cell lung cancer. Non-small cell lung cancer is a group of lung cancers named for the kinds of cells found in the cancer and how the cells look under a microscope. Metastasis is when the cancer cells spread to other parts of the body. Advanced cancer is when the patient is diagnosed with stage III or stage IV cancer. This study includes patient's information from the database who:

• Are aged 18 years or older.
• Are confirmed to have metastatic non-small cell lung cancer on or after 1 January 2021.
• Have a positive Anaplastic Lymphoma Kinase (ALK) gene mutation or rearrangement. A gene is a part of your DNA that has instructions for making things your body needs to work and a mutation or rearrangement can cause the gene not to work properly. ALK is a protein that helps control cell growth.
• Received lorlatinib as their first treatment. All participants in this study had received the study medicine lorlatinib. It is a tablet that is taken by mouth at home. They continued to take the study medicine until their cancer was no longer responding. The study will look at the experiences of people receiving the study medicine. The study is based on information collected from Flatiron Health's Advanced NSCLC Panoramic dataset which includes: \- Diagnosis, cancer stage at diagnosis, date of diagnosis, birth year, type of medicinal treatment, date of treatment start and end, age, gender, etc.

Conditions

Non-Small-Cell Lung; ALK-positive Advanced NSCLC; ALK-positive Non-small-cell Lung Cancer; ALK-positive NSCLC

Keywords

alk-positive; advanced lung cancer; metastatic lung cancer; non-small-cell lung cancer, lung cancer

Outcome Measures

Primary Outcomes (6)

• Overall Treatment Duration of 1L Lorlatinib

  From treatment initiation (on or after 3 March 2021) to end of follow-up (date of death or EHR activity end date) (data cutoff 31 March 2026)

• Time to Discontinuation of 1L Lorlatinib

  From treatment initiation (on or after 3 March 2021) to end of follow-up (date of death or EHR activity end date) (data cutoff 31 March 2026)

• Number of Dose Changes of 1L Lorlatinib

  From treatment initiation (on or after 3 March 2021) to end of follow-up (date of death or EHR activity end date) (data cutoff 31 March 2026)

• Rate of Discontinuation of 1L Lorlatinib

  From treatment initiation (on or after 3 March 2021) to end of follow-up (date of death or EHR activity end date) (data cutoff 31 March 2026)

• Time to next treatment (TTNT)

  From treatment initiation (on or after 3 March 2021) to end of follow-up (date of death or EHR activity end date) (data cutoff 31 March 2026)

• Clinical Characteristic of Participants: Eastern Cooperative Oncology Group (ECOG) Performance Status

  From treatment initiation (on or after 3 March 2021) to end of follow-up (date of death or EHR activity end date) (data cutoff 31 March 2026)

Study Arms (1)

Advanced/metastatic non-small cell lung cancer patients

Cohort of advanced/metastatic non-small cell lung cancer patients in Flatiron Health's Advanced NSCLC Panoramic dataset.

Drug: lorlatinib

Interventions

lorlatinib DRUG

As provided in real world practice

Also known as: Lorbrena

Advanced/metastatic non-small cell lung cancer patients

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

The study population are patients with advanced/metastatic non-small cell lung cancer in Flatiron Health's Advanced NSCLC Panoramic dataset.

You may qualify if:

• Positive for ALK rearrangement
• years or older at advanced/metastatic NSCLC diagnosis date
• Initiated 1L lorlatinib in the metastatic/advanced setting between 3 March 2021 and latest data cutoff available

You may not qualify if:

• Missing ALK rearrangement status
• Use of alectinib in the adjuvant setting
• Use of lorlatinib in a clinical trial setting

Sponsors & Collaborators

• Pfizer: lead

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

lorlatinib

Condition Hierarchy (Ancestors)

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

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 28, 2026
• First Posted: May 5, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share