A Study to Learn About Patients With Non-Small Cell Lung Cancer (NSCLC) Who Took Lorlatinib as Their First Treatment
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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New York
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New York、New York、アメリカ、10001
- Pfizer
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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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.
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現実世界の実践で提供されるように
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
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Overall Treatment Duration of 1L Lorlatinib
時間枠：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)
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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)
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Time to Discontinuation of 1L Lorlatinib
時間枠：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)
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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)
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Number of Dose Changes of 1L Lorlatinib
時間枠：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)
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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)
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Rate of Discontinuation of 1L Lorlatinib
時間枠：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)
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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)
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Time to next treatment (TTNT)
時間枠：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)
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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)
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Clinical Characteristic of Participants: Eastern Cooperative Oncology Group (ECOG) Performance Status
時間枠：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)
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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)
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協力者と研究者
スポンサー
捜査官
- スタディディレクター：Pfizer CT.gov Call Center、Pfizer
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- B7461064
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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