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

7 maggio 2026 aggiornato da: Pfizer

Longitudinal Real-World Study of First-Line (1L) Lorlatinib in the United States: Performance Status and Treatment Patterns

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.

Panoramica dello studio

Stato

Attivo, non reclutante

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Non-small cell lung cancer (NSCLC) accounts for approximately 85% of all lung cancer diagnoses worldwide, most often diagnosed in advanced stages. Targeted drugs are currently the most often used therapies for advanced NSCLC patients that harbor rearrangements in the anaplastic lymphoma kinase (ALK) gene, defining a distinct molecular subtype with unique therapeutic considerations. The development of ALK targeted tyrosine kinase inhibitors (TKIs) has substantially improved outcomes for patients with advanced or metastatic NSCLC with these genetic variants. Lorlatinib, a third-generation inhibitor, is a potent TKI that is effective resistance to first- and second-generation ALK-TKIs. Based on the results of the pivotal phase III clinical trial, lorlatinib received regulatory approval for first line treatment of ALK positive metastatic NSCLC on 3 March 2021, establishing it as an important treatment option in routine clinical practice.

While randomized clinical trials provide critical evidence of efficacy and safety under controlled conditions, patients treated in real world settings may differ from trial populations with respect to baseline characteristics, comorbidities, treatment sequencing, and clinical management. Data describing duration of therapy and frequency of dose modifications as well as other clinical characteristics such as Eastern Cooperative Oncology Group (ECOG) performance status over time would help to elucidate the patient experience in the real-world as a first step while longer durations of follow-up time continue to accumulate.

The objective of this non-interventional study is to generate real-world evidence (RWE) characterizing 1L lorlatinib use among adults in the United States (US) using routinely collected electronic health record (EHR) data. This is a retrospective longitudinal cohort study of patients diagnosed with advanced/metastatic NSCLC with an ALK rearrangement treated with 1L lorlatinib after its approval on 3 March 2021 in the United States.

Tipo di studio

Osservativo

Iscrizione (Effettivo)

200

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • New York
      • New York, New York, Stati Uniti, 10001
        • Pfizer

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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

Descrizione

Inclusion Criteria:

  • Positive for ALK rearrangement
  • 18 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

Exclusion Criteria:

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
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.
Droga: lorlatinib
Come previsto nella pratica del mondo reale
Altri nomi:
  • Lobrena

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
Overall Treatment Duration of 1L Lorlatinib
Lasso di tempo: 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)
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
Lasso di tempo: 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)
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
Lasso di tempo: 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)
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
Lasso di tempo: 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)
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)
Lasso di tempo: 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)
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
Lasso di tempo: 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)
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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Pfizer

Investigatori

  • Direttore dello studio: Pfizer CT.gov Call Center, Pfizer

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 maggio 2026

Completamento primario (Stimato)

31 luglio 2026

Completamento dello studio (Stimato)

31 luglio 2026

Date di iscrizione allo studio

Primo inviato

28 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

28 aprile 2026

Primo Inserito (Effettivo)

5 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

12 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

7 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • B7461064

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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