Observational Multicenter Study in Patients Receiving Chemotherapy and Amivantamab for Metastatic Non-small Cell Lung Cancer as Part of an Early Access Program
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 16
- 主要终点
- Investigator Progression Free Survival (Investigator PFS)
研究概览
简要总结
The purpose of this observational study is to understand how well a treatment combining chemotherapy and amivantamab works in real life, and how safe it is, in adults with metastatic non-small cell lung cancer (NSCLC) who have certain EGFR gene mutations.
The study includes two groups of people:
- Group A: people with an EGFR exon 20 insertion who receive amivantamab together with platinum-based chemotherapy as their first treatment, through an early access program.
- Group B: people with an EGFR exon 19 or exon 21 mutation who receive amivantamab with platinum-based chemotherapy after having been treated with osimertinib (with or without chemotherapy), also through an early access program.
The main question the study wants to answer is:
How long can the combination of amivantamab and chemotherapy keep the cancer from coming back or getting worse in these two groups of people?
People already receiving amivantamab and chemotherapy for NSCLC through an early access program may be included. They will continue to be followed by their usual oncologist as part of their normal medical care. The study will simply collect their medical information from March 21, 2024 to October 21, 2025.
No extra tests or procedures are required. This is an observational study, carried out by the GFPC and partner centers in France.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient over 18 years old
- •Cohort A: Patient with metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) exon 20 insertion treated with amivantamab-platimum based chemotherapy via an early access program in first line setting.
- •Cohort B: Patient with metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) exon 19 or 21 treated with amivantamab-platimum based chemotherapy post osimertinib (with or without chemotherapy) via an early access program.
- •Patient covered by the French National Health Insurance system or by an approved third-party payer
- •Patient who does not object to the collection of their personal data for research purposes (an information sheet will be provided to all living participants; for deceased participants, documented non-opposition in the medical record is not required)
排除标准
- •Patient placed under legal guardianship or subject to a protective legal measure
- •Patient who explicitly refuses the collection or use of their personal data for research purposes
- •Patient not enrolled, managed, or followed at the investigating site by a qualified site investigator
研究组 & 干预措施
Cohort B
People with an EGFR exon 19 or exon 21 mutation who receive amivantamab with platinum-based chemotherapy after having been treated with osimertinib (with or without chemotherapy), also through an early access program.
Cohort A
People with an EGFR exon 20 insertion who receive amivantamab together with platinum-based chemotherapy as their first treatment, through an early access program.
结局指标
主要结局
Investigator Progression Free Survival (Investigator PFS)
时间窗: From the date of first dose of combination treatment received until the date of the first documented disease progression or to death from any cause, whichever comes first, assessed for a 2-year-period maximum
The Investigator Progression Free Survival is defined as the time between chemotherapy and amivantamab combination treatment initiation date and date of first documentation of disease progression defined by the Response Evaluation Criteria in Solid Tumor (RECIST) 1.1 progression or death for any cause, whichever comes first. Disease progression will be evaluated according to (RECIST) 1.1 assessed locally. Frequency of this assessment is let at the investigator 's discretion as per local practices. The participants will be followed until disease progression or death for any cause. Patients without an event at the time of analysis will be censored at the date of their last tumor assessment.
Independent Panel Progression Free Survival (Independent Panel PFS)
时间窗: From the date of first dose of treatment received until the date of the first documented disease progression or to death from any cause, whichever comes first, assessed for a 2-year-period maximum
The Independent Panel Progression Free Survival is defined as the time between chemotherapy and amivantamab combination treatment initiation date and date of first documentation of disease progressionnt defined by the Response Evaluation Criteria in Solid Tumor (RECIST) 1.1 progression or death for any cause, whichever comes first. Disease progression will be evaluated according to (RECIST) 1.1 centrally by an independent panel based on images provided by the site. The participants will be followed until disease progression or death for any cause. Patients without an event at the time of analysis will be censored at the date of their last tumor assessment.
次要结局
- Baseline Clinical Characteristics(At Baseline visit, on a maximum period of 12 months)
- Overall Survival (OS)(Continuously from treatment start until death, withdrawal of consent, loss to follow up, or end of study, whichever occurs first, for a 2-year-period maximum)
- Investigator Objective Response Rate (Investigator ORR)(From the date of first dose of treatment combination received until the date of the first documented disease progression according to RECIST 1.1 or to death from any cause, whichever comes first, assessed for a 2-year-period maximum)
- Independent Panel Objective Response Rate (Independent Panel ORR)(From the date of first dose of treatment combination received until the date of the first documented disease progression according to RECIST 1.1 or to death from any cause, whichever comes first, assessed for a 2-year-period maximum)
- Adverse events(From the combination treatment start date up to a 2-year-period maximum)
- Treatment duration(From the combination treatment start date up to a 2-year-period maximum)
- Independent Panel Central Nervous System Progression Free Survival (Independent Panel CNS PFS)(From the date of first dose of treatment received until the date of the first documented disease progression according to RECIST 1.1 or to death from any cause, whichever comes first, assessed for a 2-year-period maximum)
- Reasons for discontinuation(From the combination treatment start date up to a 2-year-period maximum)
- Site of progression after treatment combination administration(Assessed at each tumor evaluation scheduled as per local practice, from first dose of combination therapy until end of treatment or study completion, whichever occurs first for a 2-year-period maximum)
- Description of Post-progression type of treatments(From date of first lung cancer treatment administration for a 2-year-period maximum)
- Post-progression Progression Free Survival (ppPFS)(Assessed at each site visit scheduled as per local practice, from initiation of the first post-progression treatment until documented progression, death, end of treatment, or study completion, whichever occurs first, for a 2-year-period maximum)
- Treatment outcomes by patients' baseline and disease characteristics(Assessed at each site visit scheduled as per local practice, from first dose of combination therapy until end of treatment or study completion, whichever occurs first for a 2-year-period maximum)
- Investigator Central Nervous System Objective Response Rate (Investigator CNS ORR)(From the date of first dose of treatment combination received until the date of the first documented disease progression according to RECIST 1.1 or to death from any cause, whichever comes first, assessed for a 2-year-period maximum)
- Independent Panel Central Nervous System Objective Response Rate (Independent Panel CNS ORR)(From the date of first dose of treatment combination received until the date of the first documented disease progression according to RECIST 1.1 or to death from any cause, whichever comes first, assessed for a 2-year-period maximum)
- Investigator Central Nervous System Progression Free Survival (Investigator CNS PFS)(From the date of first dose of treatment received until the date of the first documented disease progression according to RECIST 1.1 or to death from any cause, whichever comes first, assessed for a 2-year-period maximum)
- Central Nervous System Overall Survival (CNS OS)(Continuously from treatment start until death, withdrawal of consent, loss to follow up, or end of study, whichever occurs first, for a 2-year-period maximum)
- Performance status(At Baseline visit, on a maximum period of 12 months)
- Age of the patient at Baseline(At Baseline visit, on a maximum period of 12 months)
- Body weight at Baseline(At Baseline visit, on a maximum period of 12 months)
- Body mass index at Baseline(At Baseline visit, on a maximum period of 12 months)
- Description of the number of cycles per post-progression treatments(From date of first lung cancer treatment administration for a 2-year-period maximum)
- Description of the duration of each post-progression treatment(From date of the first lung cancer treatment administration for a 2-year-period maximum)