A Randomised, Open-label, Phase 3 Trial Comparing the Efficacy and Safety of OSE2101 Versus Docetaxel in HLA-A2 Positive Patients With Metastatic Non-Small Cell Lung Cancer (NSCLC) With Secondary Resistance to Immune Checkpoint Inhibitor
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 363
- 试验地点
- 407
- 主要终点
- OS defined as time from randomization to death
研究概览
简要总结
Multicenter, randomized (2:1), open-label phase 3 study in HLA-A2 positive patients with squamous and non-squamous metastatic NSCLC with ICI secondary resistance.
Patients will be randomized into 2 arms (randomization 2:1): experimental Arm A with OSE2101 monotherapy or control Arm B SoC with docetaxel monotherapy. Stratification factors will be histology (squamous versus non squamous) and ECOG Performance Status (0 versus 1).
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
- •Male or female, aged ≥ 18 years
- •Patients expressing HLA-A2 phenotype in blood by pre-screening central laboratory
- •Patients with histologically or cytologically squamous or non-squamous documented NSCLC, metastatic stage at study entry, not eligible for definite surgery or radiation, without EGFR, ALK and ROS1 gene alterations eligible for targeted therapy; for patients with squamous NSCLC, the molecular tests are not mandatory if age ≥ 50 years old and smoker ≥ 15 pack years; other sensitizing mutations known to be immunosensitive are eligible in case of lack of local access to targeted therapy (i.e.; KRAS G12C and BRAF mutations) after Sponsor' agreement.
- •Patients with secondary resistance to ICI;
- •Other inclusion and
排除标准
- •will apply per protocol.
研究组 & 干预措施
Arm A: OSE2101
Unit dose: 1 mL corresponding to a total of 5 mg of the combination of peptides Mode/Route: Subcutaneous injection Regimen: One injection every three weeks for six cycles, then every eight weeks for the remainder of year one and, finally every twelve weeks until the end of second year.
干预措施: OSE2101 (Drug)
Arm A: OSE2101
Unit dose: 1 mL corresponding to a total of 5 mg of the combination of peptides Mode/Route: Subcutaneous injection Regimen: One injection every three weeks for six cycles, then every eight weeks for the remainder of year one and, finally every twelve weeks until the end of second year.
干预措施: NGS HLAA2 assay (Device)
GenDx CDx Tedopi
System of qualitative companion diagnostic devices, consisting of a polymerase chain reaction (PCR) assay Amp-HLA-A-CDx Tedopi, a DNA library preparation assay, LFK-CDx Tedopi and the software NGSengine-CDx Tedopi.
干预措施: NGS HLAA2 assay (Device)
Arm B: Docetaxel
Unit dose: 75 mg/m2 Mode/Route: Intravenous infusion over 1 hour Regimen: One infusion every three weeks.
干预措施: NGS HLAA2 assay (Device)
Arm B: Docetaxel
Unit dose: 75 mg/m2 Mode/Route: Intravenous infusion over 1 hour Regimen: One infusion every three weeks.
干预措施: Docetaxel (Drug)
结局指标
主要结局
OS defined as time from randomization to death
时间窗: From randomization date through study completion, an average of 3 years
OS defined as time from randomization to death of any cause, censored until the data analysis cut-off date
次要结局
未报告次要终点