2024-514048-98-00招募中3 期
A Double-Blind, Randomized, Active-Controlled, Parallel-Group, Phase 3 Study to Compare Efficacy and Safety of CT-P51 and Keytruda in Combination with Platinum-Pemetrexed Chemotherapy in Patients with Previously Untreated Metastatic Non-Squamous Non-Small Cell Lung Cancer
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 210
- 试验地点
- 29
- 主要终点
- ORR (CR + PR) based on the confirmed BOR by the end of Cycle 11 according to RECIST version 1.1 in the ITT set
研究概览
简要总结
The primary objective of this study is to demonstrate the therapeutic equivalence of CT-P51 and Keytruda in terms of ORR based on the confirmed best overall response (BOR) by the end of Cycle 11 according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 in the intent-to-treat(ITT) set.
研究设计
- 分配方式
- Randomized
- 主要目的
- Extenstion Treatment Period
- 盲法
- None
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
- •Male or female ≥ 18 years
- •Stage IV, non squamous NSCLC
- •Patient with negative result in both EGFR mutation and ALK rearrangement. Patients already known to have ROS1 rearrangement, MET exon 14 skipping, RET rearrangement, or BRAF V600E mutation will be excluded if ROS1, MET, RET, or BRAF-directed therapy is indicated by local guidelines
- •Have a tumor sample not irradiated prior to biopsy that is adequate for PD-L1 assessment by immunohistochemistry (IHC) assay and obtained within 6 months prior to randomization
- •Have not received prior systemic anticancer therapy for metastatic nsNSCLC (Prior adjuvant/neoadjuvant NSCLC therapy is permitted if completed at least 12 months prior to the development of metastatic disease.)
- •Have at least 1 measurable lesion per RECIST version 1.1 (Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.) a) Tumor lesions: ≥ 10 mm in long axis by CT scan b) Malignant lymph nodes: ≥ 15 mm in short axis by CT scan
- •Have a ECOG Performance score of ≤ 1, Life expectancy of at least 3 months
- •Have adequate organ function
排除标准
- •Have predominantly squamous cell histology NSCLC. Mixed tumors will be categorized by the predominant cell type; if small cell elements are present, the patient is ineligible
- •Have carcinomatous meningitis or active CNS metastases. (Note: Patients with previously treated brain metastases at least 2 weeks prior to the first study drug administration and without suspicion of further CNS progression may participate.)
- •Have clinically significant third-space fluid; for example, ascites or pleural effusion that cannot be controlled by drainage or other procedures prior to the first dose
- •Had prior treatment with one or more of followings: a) anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-antibody, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathway b) any systemic anticancer therapy for metastatic disease c) major surgery (<3 weeks prior to the first dose) d) palliative radiotherapy for non-CNS metastases (<1 week prior to the first dose) e) radiotherapy to the lung that is of > 30 Gy (<6 months prior to the first dose)
- •Have known history of malignancy other than NSCLC in the past 5 years except adequately treated basal and squamous cell carcinoma of the skin or carcinoma in situ of the cervix
- •Is expected to require chronic systemic steroids
- •Have an active infection requiring systemic therapy (<2 weeks prior to the first dose)
- •Have interstitial lung disease or a history of pneumonitis that required steroids
- •Unable or unwilling to take folic acid or vitamin B12 supplementation
结局指标
主要结局
ORR (CR + PR) based on the confirmed BOR by the end of Cycle 11 according to RECIST version 1.1 in the ITT set
ORR (CR + PR) based on the confirmed BOR by the end of Cycle 11 according to RECIST version 1.1 in the ITT set
次要结局
未报告次要终点
研究者
Clinical Planning
Scientific
Celltrion Inc.
研究点 (29)
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