A Randomized Phase II Trial of Cemiplimab Plus OSE2101 ( TEDOPI®) as Maintenance Therapy in ctDNA Positive NSCL. The Cemited Study.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- ctDNA clearance rate
研究概览
简要总结
This is a phase II randomized study investigating whether a combination maintenance with Cemiplimab and OSE2101 (TEDOPI®) could increase ctDNA clearance rate versus standard maintenance therapy in HLA-A2 positive NSCLC patients not progressing after 4 cycles of chemo-immunotherapy.
详细描述
This is a phase II randomized study investigating whether a combination maintenance with Cemiplimab and OSE2101 (TEDOPI®) could increase ctDNA clearance rate versus standard maintenance therapy in HLA-A2 positive NSCLC patients not progressing after 4 cycles of chemo-immunotherapy.
NSCLC patients with any histology, irrespective of PD-L1 expression levels and candidates for first line metastatic therapy will be screened for HLA-A2 status.
After evaluation of all inclusion and exclusion criteria and after informed consent signature, all eligible patients will receive up to four cycles of chemotherapy and Cemiplimab. The chemotherapy regimen will be selected by the investigator, in accordance with current clinical practice, favoring the use of platinum-based chemotherapy agents.
Patients not progressing after 4 cycles of chemo-immunotherapy will be evaluated for the cTDNA presence (baseline).
If they are positive for ctDNA will be further randomized to standard maintenance therapy or to the combination maintenance of Cemiplimab and OSE2101 (TEDOPI®). In case of ctDNA negative test will be treated with Cemiplimab according to clinical practice.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed diagnosis of non- oncogene addicted advanced, locally advanced (not suitable for definitive chemoradiation therapy) or metastatic non-small-cell lung cancer (NSCLC)
- •Any patient candidate for first line chemo-immunotherapy irrespective of PD-L1 levels
- •HLA-A2 positive
- •ECOG PS 0-1
- •Signed informed consent (IC) prior to any trial-specific procedures
排除标准
- •Patients not candidate for chemo-immunotherapy
- •HLA-A2 negative
- •Symptomatic or not previously treated and not stable brain metastases. Brain metastases are allowed if asymptomatic or pretreated
- •Tumor tissue not available (archive or collected before trial inclusion)
- •Evidence of EGFR mutations or ALK or ROS1 rearrangements
- •Performance status >1 (ECOG)
- •Diagnosis of another cancer in the last 3 years, except for in situ carcinoma of cervix, breast and bladder or skin carcinoma(squamous or basaloid)
研究组 & 干预措施
A
Cemiplimab 350 mg iv q21 single agent (squamous histology) or Cemiplimab 350 mg iv q21 plus pemetrexed 500mg/m2 q21 (non- squamous histology).
干预措施: Cemiplimab (Drug)
B
Cemiplimab 350 mg iv q 21 plus OSE2101 (TEDOPI®). The OSE2101 (TEDOPI®) dose to be injected is of 1 mL (5 mg of drug product) by subcutaneousubcutaneous administration
干预措施: Tedopi (Drug)
结局指标
主要结局
ctDNA clearance rate
时间窗: 48 months
Differences in ctDNA clearance rate in the two arms of treatment Differences in ctDNA clearance rate in the two arms of treatment Differences in ctDNA clearance rate in the two arms of treatment Differences in ctDNA clearance rate in the two arms of treatment
次要结局
未报告次要终点