2023-506886-76-00招募中4 期
Standard dosed alectinib versus Therageutic Drug Monitoring guided alectinib dosing: The Adapt Alec trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 196
- 试验地点
- 9
- 主要终点
- The main endpoint will be an increase in progression free survival (PFS according to RECIST v1.1) in the subgroups of patients with an alectinib Cmin treshhold <435 ng/mL in the TDM-guided dosing cohort versus the same subgroup in the fixed dosing cohort
研究概览
简要总结
The primary objective will be a prolonged mPFS for the TDM-guided dosing cohort versus the standard fixed dosing cohort in the group of patients with an alectinib Cmin below the threshold of <435 ng/mL.
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
- •Patients with locally advanced or metastatic NSCLC (stage IIIB to stage IV by AJCC 8th)
- •Observational other studies are allowed for patients included in this study
- •Local radiotherapy is allowed for pain
- •Male or female >=18 years old
- •ECOG Performance Status of 0-4
- •Histologically or cytology confirmed NSCLC
- •Documented ALK rearrangement based on an EMA approved test
- •Patients can either be chemotherapy-naïve or have received one line of platinumbased chemotherapy
- •Patients with brain or leptomeningeal metastases are allowed on the study if the lesions are asymptomatic without neurological signs and clinically stable for at least 2 weeks without steroid treatment. Patients who do not meet these criteria are not eligible for the study.
- •Measurable disease (by RECIST criteria version 1.1) prior to the first dose of study treatment
- •Signed written Institutional Review Board (IRB)/Ethical Committee (EC) approved informed consent form, prior to performing any study-related procedures.
排除标准
- •Any significant concomitant disease determined by the investigator to be potentially aggravated by the investigational drug
- •Consumption of agents which modulate CYP3A4 or agents with potential QT prolonging effects within 14 days prior to admission and during the study (see concomitant medication restrictions)
- •Any clinically significant concomitant disease or condition that could interfere with, or for which the treatment might interfere with, the conduct of the study, or absorption of oral medications, or that would, in the opinion of the Principal Investigator, pose an unacceptable risk to the subject in this study.
- •Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol requirements and/or follow-up procedures; those conditions should be discussed with the patiënt before trial entry.
结局指标
主要结局
The main endpoint will be an increase in progression free survival (PFS according to RECIST v1.1) in the subgroups of patients with an alectinib Cmin treshhold <435 ng/mL in the TDM-guided dosing cohort versus the same subgroup in the fixed dosing cohort
The main endpoint will be an increase in progression free survival (PFS according to RECIST v1.1) in the subgroups of patients with an alectinib Cmin treshhold <435 ng/mL in the TDM-guided dosing cohort versus the same subgroup in the fixed dosing cohort
次要结局
- Feasibility and safety of TDM. This will be measured as percentage of successful TDM measures, in which successful is defined as target attainment with manageable toxicity.
- Physician adherence to TDM advice. This will be measured as the percentage of dose recommendations that are implemented by the treating physicians.
- Overall response rates (ORR). ORR will be defined as partial response or complete response (according to RECIST v1.1) percentage of the total treated population.
- Median overall survival (mOS). OS will be defined as the time from randomization to death from any cause in the total population. Patients who do not die or are lost to follow-up will be censored at their last available date.
- Intracranial PFS. The intracranial PFS will be measured as time from start of treatment to progressive disease in the brain, or death from any cause. Patients who did not die or progress, or lost to follow-up, will be censored at their last available date.
- Patient adherence. This will be estimated by pill counts of returned medication as well as a patient diary on drug intake.
- Toxicity related to the plasma concentration and dose increases. This will be defined as AE’s in the subgroups with Cmin < 435 ng/mL and all Cmin ≥ 435 ng/mL, and in patients who did and who did not receive a PK-guided dose increase.
- Quality of life (QoL). This will be determined using the EORTC QLQ_LC13 as addition to the QLQ-C30 questionnaire, and the EQ-5D-5L questionnaire.
- Cost-effectiveness. This will be determined by the incremental cost-effectiveness ratio based on costs and quality adjusted life-years (QALYs)
- Alectinib-M4 concentrations. These will be measured in the alectinib plasma samples.
研究者
Longoncologie UMCG - dr AJ van der Wekken
Scientific
Universitair Medisch Centrum Groningen
研究点 (9)
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