2024-513881-20-00
进行中（未招募）
2 期
First-line treatment with osimertinib in EGFR-mutated non-small cell lung cancer, coupled to extensive translational studies (The FIOL-study)
Vestre Viken HF5 个研究点 分布在 3 个国家目标入组 96 人开始时间: 2024年11月14日最近更新:
概览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- Vestre Viken HF
- 入组人数
- 96
- 试验地点
- 5
- 主要终点
- To assess the efficacy of osimertinib by assessment of objective response rate (ORR).
概览
简要总结
To assess the efficacy of osimertinib by assessment of objective response rate (ORR)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated, written informed consent.
- •Age > 18 years.
- •Histologically or cytologically documented locally advanced or metastatic NSCLC not amenable to curative surgery or radiotherapy. Patients that have received systemic adjuvant therapy for non-metastatic disease in the past will need a new biopsy before inclusion.
- •Documented EGFR mutation in exon 18-21, except insertions in exon 20, based on tissue analysis
- •ECOG status 0-2 and a minimum life expectancy of 12 weeks.
- •Patients with untreated, mild or moderately symptomatic and measurable brain metastases are eligible, but will be allocated to cohort A (see excl. point 6). Patients with pre-treated, stable and asymptomatic brain metastases will be allocated to cohort B.
- •At least one lesion, not previously irradiated and not chosen for biopsy during the study screening period, that can be accurately measured at baseline according to RECIST 1.
- •Females should be using adequate contraceptive measures (see appendix E), should not be breast feeding and must have a negative pregnancy test prior to start of dosing if of childbearing potential or must have evidence of non-child-bearing potential by fulfilling one of the following criteria at screening: Post-menopausal defined as aged more than 50 years and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments Women under 50 years old would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatments and with Luteinizing Hormone (LH) and Follicle-Stimulating Hormone (FSH) levels in the post-menopausal range for the institution Documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation.
- •Male subjects must be willing to use barrier contraception
排除标准
- •Previous systemic treatment against metastatic NSCLC.
- •Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease.
- •Inadequate bone marrow reserve or organ function (as demonstrated by any of the following laboratory values: Absolute neutrophil count < 1.5 x 109/L Platelet count < 100 x 109/L Haemoglobin < 90 g/L Alanine aminotransferase (ALT) > 2.5 times the upper limit of normal (ULN) if no demonstrable liver metastases or > 5 times ULN in the presence of liver metastases Aspartate aminotransferase (AST) > 2.5 times ULN if no demonstrable liver metastases or > 5 times ULN in the presence of liver metastases Total bilirubin > 1.5 times ULN if no liver metastases or > 3 times ULN in the presence of documented Gilbert’s Syndrome (unconjugated hyperbilirubinaemia) or liver metastases Serum creatinine >1.5 times ULN concurrent with creatinine clearance <50 mL/min [measured or calculated by Cockcroft and Gault equation]—confirmation of creatinine clearance is only required when creatinine is >1.5 times ULN
- •History of hypersensitivity of active or inactive excipients of osimertinib or drugs with a similar chemical structure or class to osimertinib.
- •Treatment with an investigational drug within five half-lives of the compound or 3 months, whichever is greater.
- •Previous enrolment in the present study or previous treatment with osimertinib.
- •Any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of starting study treatment, with the exception of alopecia and grade 2, prior platinum-therapy-related neuropathy.
- •Women who are pregnant or breast-feeding, or have a positive (urine or serum) pregnancy test prior to study entry
- •Involvement in the planning and/or conduct of the study (investigator staff and/or staff at the study site).
- •Judgment by the investigator that the subject should not participate in the study if the subject is unlikely to comply with study procedures, restrictions and requirements.
结局指标
主要结局
To assess the efficacy of osimertinib by assessment of objective response rate (ORR).
To assess the efficacy of osimertinib by assessment of objective response rate (ORR).
次要结局
- To further assess the efficacy of osimertinib in terms of Progression free survival (PFS)
- To further assess the efficacy of osimertinib in terms of Duration of Response (DoR)
- To further assess the efficacy of osimertinib in terms of Disease Control Rate (DCR)
- To further assess the efficacy of osimertinib in terms of Intracranial ORR
- To further assess the efficacy of osimertinib in terms of intracranial DoR
- To further assess the efficacy of osimertinib in terms of intracranial progression free survival (iPFS)
- To further assess the efficacy of osimertinib in terms of tumour shrinkage
- To further assess the efficacy of osimertinib in terms of overall survival (OS)
- To confirm the safety profile of osimertinib
- Exploratory objectives Molecular characterization of blood and tissue before commencement on osimertinib, and at progression on osimertinib
- Exploratory objectives: NGS (deep sequencing) of tumour tissue
- Exploratory objectives: Array-based microRNA, methylation, mRNA expression
- Exploratory objectives : Immunohistochemistry (IHC) on AXL, cMET, CD73 etc
- Exploratory objectives: Exploratory analyses to be determined
- Mutational analyses (ctDNA) and conventional tumour markers during therapy
研究者
Siri Bråthen
Scientific
Vestre Viken HF
研究点 (5)
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