Prospective Non-Interventional Study Comparing Standard of Care Osimertinib +/- Chemotherapy for EGFR-Mutated Non-Small Cell Lung Cancer (NSCLC) Patients
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- PrECOG, LLC.
- 入组人数
- 200
- 试验地点
- 397
- 主要终点
- real-world Progression-Free Survival (rwPFS)
研究概览
简要总结
The goal of the study is to collect data on patients treated outside of a clinical trial (in routine clinical practice) with standard of care osimertinib with or without chemotherapy in Epidermal Growth Factor Receptor (EGFR)-mutant Non-Small Cell Lung Cancer (NSCLC) to better understand the safety and effectiveness of these standard of care regimens.
详细描述
This study tests the feasibility of using real-world data collection through the recruitment of well-characterized patients into a registry, spanning academic and community practice sites to determine patient outcomes in all-comers. The scientific community would further benefit from a greater understanding of the safety and effectiveness of newly approved therapies prescribed in routine clinical practice.
Non-interventional (observational) study with 250 participants per exposure group (maximum accrual up to 538 total participants) comparing outcomes in patients with EGFR-mutated NSCLC, not being treated in a clinical trial but receiving standard of care osimertinib +/- chemotherapy.
The treating physician determines whether a patient will receive standard of care single agent osimertinib or osimertinib with chemotherapy and the planned treatment is recorded at registration.
Clinical/Imaging assessments will be per the treating physician.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must have a pathologically-confirmed diagnosis of non-small cell lung cancer (NSCLC).
- •Patient must have advanced disease, defined as IIIB (not amenable to definitive multi-modality therapy), IIIC, or IV (includes local or distant recurrent disease after a prior diagnosis of Stage I-III disease). All staging is via the American Joint Committee on Cancer (AJCC)/International Association for the Study of Lung Cancer (IASLC) 8th edition staging criteria.
- •Patient tumor must have somatic activating sensitizing mutation in EGFR (e.g., but not limited to Exon 19 deletion, L858R, E709X, G719X, exon 19 insertions, L861Q, S768I). Patients with non-sensitizing mutations in EGFR (EGFR exon 20 insertions) are not eligible. Plasma, cytology, or tumor tissue can be utilized for standard of care mutation testing.
- •Prior chemotherapy and/or immunotherapy administered as primary treatment for NSCLC before EGFR mutation was identified is allowed ≤ 45 days of study registration to allow for return of sequencing information.
- •Prior treatment with osimertinib administered as primary treatment for NSCLC is allowed ≤ 30 days of study registration (prior treatment with any other EGFR TKI agent is not allowed).
- •Patient must not be participating in EA5182 or any other cancer treatment trial. Osimertinib or osimertinib + chemotherapy/immunotherapy given as first-line treatment for this disease cannot be given as part of a clinical trial.
- •Patients that have received prior radiation therapy in any setting for this disease are eligible.
- •Adults age ≥ 18 years.
排除标准
- 未提供
研究组 & 干预措施
Group 2
Osimertinib + Chemotherapy
干预措施: Osimertinib + Chemotherapy (Drug)
Group 1
Osimertinib
干预措施: Osimertinib (Drug)
结局指标
主要结局
real-world Progression-Free Survival (rwPFS)
时间窗: From initiation of therapy to progression or death, up to 3 years
Time from initiating therapy to progression or death without documented progression
次要结局
- real-world Overall Survival (rwOS)(From initiation of therapy to death, up to 3 years)
- real-world time to treatment discontinuation (rwTTD)(From initiation of therapy to discontinuation of osimertinib, up to 3 years)