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.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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New York
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New York, New York, 미국, 10001
- Pfizer
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
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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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실생활에서 제공되는 것과 같이
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Overall Treatment Duration of 1L Lorlatinib
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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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공동 작업자 및 조사자
스폰서
수사관
- 연구 책임자: Pfizer CT.gov Call Center, Pfizer
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- B7461064
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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로라티닙에 대한 임상 시험
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Guangdong Association of Clinical Trials모집하지 않고 적극적으로