NCT04880382终止2 期
Integrative Analysis of the Tumor Microenvironment and Optimization of the Immunotherapy Duration in Non-small Cell Lung Cancer Patients (OPTIMUNE-LUNG Study)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 9
- 主要终点
- Assessment of the long-term benefit of PD-1 inhibition in NSCLC patients who experienced a response between 6 and 12 months after initiation of ICI
研究概览
简要总结
Non-comparative multicentric randomized study to assess long-term benefit of PD-1 inhibition in NSCLC patients who experienced a response between 6 and 12 months after initiation of ICI (immune checkpoint inhibitor PD1/PDL-1 blockade therapy)
详细描述
Two-arm, non-comparative, prospective, multicentric, randomized study for early discontinuation of immune checkpoint inhibitor PD1/PDL-1 blockade therapy in non-small cell lung cancer patients who achieved objective response between 6 and 12 months after treatment onset.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Histologically or cytologically confirmed non-small cell lung carcinoma (squamous or non squamous).
- •Locally advanced/unresectable or metastatic disease.
- •For non-squamous histology, tumor with no oncogenic addiction: no activating EGFR mutation, no ALK or ROS1 rearrangement,
- •Treatment with ICI (immune checkpoint inhibitor PD1/PDL-1 blockade therapy):
- •in first or second-line treatment as per market authorization. For patients in first line, ICI alone or ICI + chemotherapy,
- •start of ICI treatment 6 to 12 months (+/- 2 weeks) before registration.
- •At least one measurable lesion according to the RECIST v1.1 criteria before ICI treatment onset and confirmed by centralized review (lesion in previously irradiated filed can be considered as measurable if progressive at inclusion according to RECIST v1.1). At least one site of disease must be uni-dimensionally ≥ 10 mm.
- •Patient with objective response according to RECIST v1.1 criteria at 6 months or more and less than 12 months after ICI treatment onset. Response must be confirmed by centralized review
- •At least one lesion that can be biopsied for research purpose.
- •Performance status <
- •Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to registration.
- •Patient with a social security in compliance with the French law (Loi Jardé).
- •Patient must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
- •Voluntarily signed and dated written informed consent prior to any study specific procedure.
排除标准
- •Female who is pregnant or breast-feeding.
- •Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study.
- •Hypersensitivity to one of the active substances or to one of the excipients
- •Any contraindication to pursue ICI treatment as per investigator judgement.
- •Previous enrolment in the present study.
- •Individual deprived of liberty or placed under legal guardianship.
研究组 & 干预措施
Standard Arm A: treatment by ICI will be continued
Other
After achieving objective response between 6 and 12 months after treatment onset, for these patients ICI treament will continue as per market authorization
干预措施: ICI treatment continuation (Drug)
Experimental Arm B: treatment by ICI will be discontinued
Experimental
After achieving objective response between 6 and 12 months after treatment onset, for these patients first-line or second line regimen should be discontinued. Patients will be followed as per standard management.
干预措施: ICI treatment discontinuation (Drug)
结局指标
主要结局
Assessment of the long-term benefit of PD-1 inhibition in NSCLC patients who experienced a response between 6 and 12 months after initiation of ICI
时间窗: 12 months
Long-term benefit will be assessed in terms of progression-free rate (PFR) at 12 months after randomization, for each therapeutic strategy
次要结局
- Assessment of secondary resistance in NSCLC patients who experienced a response to PD1/PDL-1 inhibition(12 months)
- Safety profile, independently for each therapeutic strategy: Common Terminology Criteria for Adverse Events version 5(Throughout the treatment and follow-up period, an expected average of 12 months)
- 1-year progression-free survival, independently for each therapeutic strategy(1 year)
- Duration of response independently for each therapeutic strategy(Throughout the treatment period, an expected average of 12 months)
- • To describe retreatment for arm B-patients and subsequent systemic therapies for arm A-patients(Throughout the treatment and follow-up period, an expected average of 12 months)
- Blood lymphocytes levels(At study onset (randomization) and at progression (throughout the treatment and follow-up period, an average of 12 months))
- 2-year progression-free survival, independently for each therapeutic strategy(2 years)
- 1-year overall survival, independently for each therapeutic strategy(1 year)
- 2-year overall survival, independently for each therapeutic strategy(2 years)
- Tumor immune cells levels(At study onset (randomization) and at progression (throughout the treatment and follow-up period, an average of 12 months))
- Blood kynurenine levels(At study onset (randomization) and at progression (throughout the treatment and follow-up period, an average of 12 months))
- Blood cytokines levels(At study onset (randomization) and at progression (throughout the treatment and follow-up period, an average of 12 months))
研究者
研究点 (9)
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