Prospective Non-interventional Study (NIS) to Examine the Effectiveness of Tremelimumab + Durvalumab + Platinum Chemotherapy (TDC) in Patients With Metastatic Non-squamous NSCLC and High-risk Genetic Alterations
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- AstraZeneca
- 入组人数
- 600
- 试验地点
- 32
- 主要终点
- Two-year real-world overall survival (rwOS) rate of patients with NSQ mNSCLC in patients with mutations in KRAS
研究概览
简要总结
This prospective, multicenter, non-interventional study (NIS) in Germany aims to collect real-life data of patients with non-squamous (NSQ) metastatic non-small cell lung cancer (mNSCLC) (incl. large cell neuroendocrine carcinoma (LCNEC) if considered NSCLC-like by the treating physician) for whom 1st line treatment initiation with tremelimumab and durvalumab in combination with a platinum-based chemotherapy (TDC) according to marketing authorization was scheduled. The study aims to describe the effectiveness with respect to mutations in Kirsten rat sarcoma viral oncogene homolog (KRAS), Serine/threonine kinase 11 (STK11), Kelch-like ECH-associated protein 1 (KEAP1), and Tumor protein p53 (TP53) as well as expression of Thyroid transcription factor 1 (TTF-1) and Programmed death-ligand 1 (PD-L1) in routine clinical practice. The generated data aims to deepen the understanding of optimal, biomarker-guided treatment strategies for NSQ mNSCLC in distinct subgroups with a high medical need.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥ 18 years
- •Decision to start first-line (1L) treatment with TDC according to the current SmPCs
- •Histologically or cytologically confirmed diagnosis of NSQ mNSCLC (incl. LCNEC if considered NSCLC-like by the treating physician)
- •No sensitizing epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) alterations
- •Molecular Next Generation Sequencing (NGS) panel as per institutional standard has been initiated (including the following genes: KRAS, STK11, KEAP1, and TP53)
- •TTF-1 expression analysis has been initiated
- •PD-L1 expression analysis has been initiated
- •Women of childbearing potential must use effective contraception during treatment with durvalumab and for at least 3 months after the last dose of durvalumab
- •Ability to understand the study concept
- •Provision of signed informed consent form in accordance with applicable local provisions
排除标准
- •Current participation in interventional clinical trials
- •Contraindications according to current SmPCs
- •Any active tumor other than metastatic NSCLC*
- •Mixed histology NSCLC with both adenocarcinoma and squamous cell carcinoma components (adenosquamous carcinoma or any mixed NSQ- squamous tumor), regardless of the predominant component
- •determined by investigator as likely to influence the prognosis or management of mNSCLC
结局指标
主要结局
Two-year real-world overall survival (rwOS) rate of patients with NSQ mNSCLC in patients with mutations in KRAS
时间窗: Time from patient's index date until death by any cause, up to 24 months
rwOS rate (percentage of patients being alive derived by Kaplan-Meier methods) at 24 months in patients with mutations in KRAS. Patients without a date of death will be censored at last activity in the database, or the end of the study period, whichever occurs first.
Two-year real-world overall survival (rwOS) rate of patients with NSQ mNSCLC in patients with mutations in STK11
时间窗: Time from patient's index date until death by any cause, up to 24 months
rwOS rate (percentage of patients being alive derived by Kaplan-Meier methods) at 24 months in patients with mutations in STK11. Patients without a date of death will be censored at last activity in the database, or the end of the study period, whichever occurs first.
Two-year real-world overall survival (rwOS) rate of patients with NSQ mNSCLC in the total study population
时间窗: Time from patient's index date until death by any cause, up to 24 months
rwOS rate (percentage of patients being alive derived by Kaplan-Meier methods) at 24 months in the total study population. Patients without a date of death will be censored at last activity in the database, or the end of the study period, whichever occurs first.
Two-year real-world overall survival (rwOS) rate of patients with NSQ mNSCLC in patients with mutations in KRAS
时间窗: Time from patient's index date until death by any cause, up to 24 months
rwOS rate (percentage of patients being alive derived by Kaplan-Meier methods) at 24 months in patients with mutations in KRAS. Patients without a date of death will be censored at last activity in the database, or the end of the study period, whichever occurs first.
Two-year real-world overall survival (rwOS) rate of patients with NSQ mNSCLC in patients with mutations in STK11
时间窗: Time from patient's index date until death by any cause, up to 24 months
rwOS rate (percentage of patients being alive derived by Kaplan-Meier methods) at 24 months in patients with mutations in STK11. Patients without a date of death will be censored at last activity in the database, or the end of the study period, whichever occurs first.
次要结局
- Real-world overall survival (rwOS) in a subgroup of patients with mutation in KRAS(6, 12 and 18 months)
- Median overall survival (mOS) in a subgroup of patients with mutation in KRAS(up to 24 months)
- Real-world overall survival (rwOS) in a subgroup of patients with mutation in STK11(6, 12 and 18 months)
- Median overall survival (mOS) in a subgroup of patients with mutation in STK11(up to 24 months)
- Real-world treatment response of TDC, as judged by the treating physician(up to 24 months)
- Duration of response (DoR)(up to 24 months)
- Real-world progression-free survival (rwPFS)(up to 24 months)
- Safety: Collection of Adverse Events (AE)(up to 24 months)
- Median overall survival (mOS) in a subgroup of patients with mutation in KRAS(up to 24 months)
- Real-world overall survival (rwOS) in a subgroup of patients with mutation in STK11(6, 12 and 18 months)
- Median overall survival (mOS) in a subgroup of patients with mutation in STK11(up to 24 months)
- Real-world treatment response of TDC, as judged by the treating physician(up to 24 months)
- Duration of response (DoR)(up to 24 months)
- Real-world progression-free survival (rwPFS)(up to 24 months)
- Safety: Collection of Adverse Events (AE)(up to 24 months)
- Real-world overall survival (rwOS) in the total study population(6, 12 and 18 months)
- Median overall survival (mOS) in the total study population(up to 24 months)
- Real-world overall survival (rwOS) in a subgroup of patients with mutation in KRAS(6, 12 and 18 months)