NCT07361497招募中3 期
ROSETTA Lung-201: A Randomized, Multicenter, Open-label Phase 3 Study of Pumitamig Monotherapy Compared to Durvalumab in Participants With Unresectable Stage III NSCLC Without Progression After Platinum-based Concurrent Chemoradiation Therapy.
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 850
- 试验地点
- 305
- 主要终点
- Progression-free survival (PFS) by blinded independent central review (BICR) (per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1)
研究概览
简要总结
A study to evaluate Pumitamig versus Durvalumab following concurrent chemoradiation therapy in participants with unresectable stage III Non-small Cell Lung Cancer (NSCLC)
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
- •Participants must have a histologically- or cytologically-confirmed diagnoses of non-small cell lung cancer (NSCLC) with unresectable Stage III disease.
- •Participants must have received at least 2 cycles of platinum-based concurrent chemoradiotherapy (a total dose of radiation of at least 54 Gy).
- •Participants must have no progressive disease (PD) following treatment with concurrent chemoradiotherapy (CCRT).
- •Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1.
排除标准
- •Participants with non-squamous histology must not have documented Epidermal Growth Factor Receptor (EGFR) and anaplastic lymphoma kinase (ALK) rearrangements.
- •Participants must not have an active autoimmune disease.
- •Participants must not have significant cardiovascular impairment such as uncontrolled hypertension (despite optimal medical treatment), congestive heart failure, active coronary disease (within 6 months prior to randomization), ventricular arrhythmias, major thrombotic or embolic events or major hemorrhagic events within 6 months prior to randomization, or significant risk of pulmonary hemorrhage.
- •Participants must not have advanced/clinically significant lung disease (within 6 months prior to randomization) or history of interstitial lung disease (ILD) or pneumonitis requiring treatment with systemic steroids (≥ Grade 2), or current or suspected ILD or pneumonitis.
- •Participants must not have any prior anticancer therapy (outside of CCRT) for locally advanced Stage III disease.
- •Other protocol-defined Inclusion/Exclusion criteria apply.
研究组 & 干预措施
Arm A
Experimental
干预措施: Pumitamig (Drug)
Arm B
Active Comparator
干预措施: Durvalumab (Drug)
结局指标
主要结局
Progression-free survival (PFS) by blinded independent central review (BICR) (per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1)
时间窗: Up to 3 years
次要结局
- Overall survival (OS)(Up to approximately 9 years)
- PFS by investigator (per RECIST v1.1)(Up to 3 years)
- Objective response (OR) by BICR (per RECIST v1.1)(Up to 3 years)
- Disease control rate (DCR) by BICR (per RECIST v1.1)(Up to 3 years)
- Duration of response (DOR) by BICR (per RECIST v1.1)(Up to 3 years)
- Time to Response (TTR) by BICR (per RECIST v1.1)(Up to 3 years)
研究者
研究点 (305)
Loading locations...
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