2023-509766-37-00已完成3 期
A Multicenter, Randomized, Double-blind Trial to Demonstrate Similar Efficacy, Safety, and Immunogenicity of FYB206 (Keytruda Biosimilar Candidate) in Comparison to Keytruda (Pembrolizumab) as an Add-on to Chemotherapy in Treatment-naïve Patients with Metastatic Non-squamous Non-small Cell Lung Cancer (LOTUS)
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Formycon AG
- 入组人数
- 81
- 试验地点
- 12
- 主要终点
- Measured as the proportion of participants whose cancer resolves completely or partially after approximately 9 months (40 weeks) from the start of treatment
研究概览
简要总结
To demonstrate the comparable effectiveness of FYB206 to Keytruda as an add-on treatment to chemotherapy in patients with metastatic NSCLC
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
- 是
入选标准
- •Histologically confirmed or cytologically confirmed diagnosis of Stage IV non-squamous NSCLC.
- •No prior systemic treatment for metastatic non-squamous NSCLC. Patients who received adjuvant or neoadjuvant therapy are eligible if the adjuvant/neoadjuvant therapy was completed at least 12 months prior to the development of metastatic disease.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Confirmation that EGFR or ALK--directed therapy is not indicated (ie, documentation of absence of tumor--activating/sensitizing EGFR mutations AND absence of ALK gene rearrangements). Note if patient does not have documented genetic test results for EGFR and ALK available at the moment of ICF signature, it will be performed during screening locally.
排除标准
- •Small cell lung cancer (SCLC) or combination of SCLC and NSCLC. Squamous cell tumors and mixed adenosquamous carcinomas of predominantly squamous nature.
- •Known one of the mutations listed below: o ROS1 fusion gene o BRAF-V600E o RET fusion o MET Exon 14
- •Known active central nervous system metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are clinically stable for at least 2 weeks and have no evidence of new or enlarging brain metastases and are also off steroids 3 days prior to dosing with trial treatment. Stable brain metastases by this definition should be established prior to the first dose of trial treatment. Patients with known untreated, asymptomatic brain metastases (ie, no neurological symptoms, no requirements for corticosteroids, no or minimal surrounding edema, and no lesion >1.5 cm) may participate but will require regular imaging of the brain as a site of disease.
- •Prior treatment with any anti-programmed cell death 1, PD-L1, or programmed cell death ligand 2 agent or an antibody targeting other immuno-regulatory receptors or mechanisms. Examples of such antibodies include (but are not limited to) antibodies against indoleamine 2, 3-dioxygenase, PD-L1, interleukin 2 receptor, or glucocorticoid-induced tumor necrosis factor receptor-related protein.
结局指标
主要结局
Measured as the proportion of participants whose cancer resolves completely or partially after approximately 9 months (40 weeks) from the start of treatment
Measured as the proportion of participants whose cancer resolves completely or partially after approximately 9 months (40 weeks) from the start of treatment
次要结局
- Measured as: proportion of participants (1) whose cancer resolves completely or partially at prespecified timepoints during the first year, (2) without disease progression* or death after one year. (3) alive after one year, (4) time for cancer to resolve completely or partially, (5) time from cancer resolving completely or partially until disease progression.
- *Disease progression means significant tumor growth compared to the previous measurement. Identify and monitor the side effects, vital signs, oxygen levels, laboratory test results, and other health indicators that change during the study during the first year of treatment.
- Number of participants who develop antibodies against the treatments when assessed at pre-decided timepoints. ‘Antibodies’ helps protect the body against foreign matter, such as bacteria and viruses or allergens. Sometimes, the body identifies some drugs or treatments as foreign matter and makes antibodies to fight them.
- Measured as the lowest amounts of the drug 1 hour before the next dose was given, at various points during the first year of treatment.
研究者
Clinical Trial Information Desk
Scientific
Formycon AG
研究点 (12)
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