NCT07829549尚未招募3 期
A Randomized, Double-blind, Multicenter Phase III Study of RC148 Combined With Platinum-Based Chemotherapy Versus Tislelizumab Combined With Platinum-Based Chemotherapy as First-Line Treatment for Advanced Nonsquamous Non-Small Cell Lung Cancer Without Actionable Genomic Alterations
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 540
- 试验地点
- 1
- 主要终点
- Progression-Free Survival assessed by BIRC per RECIST v1.1
研究概览
简要总结
To evaluate the efficacy and safety of RC148 plus platinum-based chemotherapy versus tislelizumab plus platinum-based chemotherapy in trial participants with previously untreated locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV), non-squamous non-small cell lung cancer without actionable genomic alterations.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Voluntarily agrees to participate in the study and provides written informed consent.
- •2. Willing and able to comply with study and follow-up procedures.
- •Male or female, aged 18 to 75 years inclusive.
- •Estimated life expectancy≥3 months.
- •ECOG performance status 0 or
- •Histologically or cytologically confirmed locally advanced or metastatic NSCLC, not amenable to curative-intent therapy.
- •7. No prior systemic anti-tumor therapy for advanced or metastatic NSCLC
- •Has at least one measurable non-central nervous system lesion per RECIST v1.
- •9. Must provide PD-L1 expression testing report and actionable genomic alterations testing report before enrollment.
- •10. Adequate cardiac, bone marrow, hepatic, renal, and coagulation function.
- •Female study participants must be postmenopausal, surgically sterile, or, if of childbearing potential, must have a negative serum pregnancy test within 7 days prior to randomization, and agree to use at least one medically acceptable contraceptive method (e.g., intrauterine device, oral contraceptives, or condoms) during study treatment and for 12 months after completion of study treatment. Female participants shall not donate ova or breastfeed during this period. Male study participants must agree to use at least one medically acceptable contraceptive method during study treatment and for 12 months after completion of study treatment, and shall not donate sperm during this period.
排除标准
- •1. Histologically confirmed presence of any squamous NSCLC, small cell carcinoma, neuroendocrine carcinoma, or sarcoma components.
- •2. Known actionable gene alterations positive or harboring gene mutations with approved first-line treatment options.
- •3. Presence of active brain metastases.
- •Screening imaging demonstrates marked tumor necrosis or cavitation, and the investigator determines that enrollment in this study may confer a risk of bleeding.
- •5. Have received chest radiotherapy >30 Gy within 6 months prior to randomization; received palliative local therapy for non-target lesions within 2 weeks prior to randomization; received non-specific immunomodulatory therapy within 2 weeks prior to randomization; or received Chinese herbal or proprietary medicines with anti-tumor indications within 1 week prior to randomization.
- •6. Have received immunotherapy, including immune checkpoint inhibitors, immune checkpoint agonists, immune cell therapy, or any other therapy targeting anti-tumor immune mechanisms.
- •7. Have received other systemic anti-tumor therapy other than chemotherapy and PD-1/PD-L1 antibodies.
- •8. Systemic treatment with corticosteroids or other immunosuppressive drugs within 2 weeks prior to randomization.
- •9. Have received any live or live-attenuated vaccine within 4 weeks prior to randomization, or plans to receive any live or live-attenuated vaccine during the study.
- •10. Participation in another clinical trial within 4 weeks prior to randomization
- •Have undergone major surgery, interventional therapy, or severe trauma within 4 weeks prior to randomization, or plans to undergo major surgery during the study period; has undergone core needle biopsy or other minor surgical procedures within 7 days prior to randomization.
- •12. Have a history of severe coagulation disorder, or is receiving anticoagulant medications, including those using prophylactic-dose anticoagulants.
- •13. Toxicities of prior anti-tumor therapy have not recovered to Grade 0-1 per CTCAE v6.0, excluding alopecia, pigmentation, expected irreversible endocrine toxicities secondary to prior immunotherapy that are stably controlled with medications, and other conditions judged by the investigator not to interfere with study drug treatment.
- •14. For participants with prior PD-1/PD-L1 inhibitor exposure: prior Grade ≥3 irAEs, irAEs resulting in permanent treatment discontinuation, Grade 2 immune-related cardiac irAEs, or any-grade neurologic or ocular irAEs; prior adverse events requiring immunosuppressants other than corticosteroids, or recurrent adverse events during prior immunotherapy requiring re-administration of systemic corticosteroids.
- •15. Have severe acute or chronic infection.
- •Occurrence of hemoptysis, active gastrointestinal bleeding, peptic ulcer, epistaxis, or other bleeding events requiring intervention within 4 weeks prior to randomization, or presence of severe esophagogastric varices, vasculitis, aneurysm, or dissection assessed by the investigator as high bleeding risk.
- •17. Serious arterial/venous thromboembolic events, cerebrovascular accident, or hypertensive encephalopathy occurring within 6 months prior to randomization.
- •18. Have active or clinically significant cardiac disease.
- •Previous and/or current interstitial lung disease, drug-related pneumonitis, radiation pneumonitis, severely impaired pulmonary function, acute exacerbation of chronic obstructive pulmonary disease within 1 month prior to randomization, or clinical signs or high-risk factors suggestive of interstitial lung disease.
- •20. Have a history of gastrointestinal perforation and/or fistula, or gastrointestinal obstruction within 6 months prior to randomization.
- •21. Presence of systemic diseases assessed by the investigator as not stably controlled.
- •22. Presence of active autoimmune disease, or prior autoimmune disease at risk of recurrence.
- •23. Have a history of other acquired or congenital immunodeficiency diseases, or a history of organ transplantation.
- •24. Have known hypersensitivity or delayed-type hypersensitivity reactions to any components of the study drug or analogous drugs.
- •25. Presence of symptomatic third-space effusion or third-space effusion requiring intervention.
- •26. Other malignancy within 5 years before initiation of study treatment.
- •Poor compliance and anticipated inability to comply with trial procedures
- •Previous or current presence of any other disease.
- •Non-malignant local or systemic disorders, or tumor-secondary diseases or symptoms associated with high medical risk and/or uncertainty in survival evaluation, e.g., cachexia.
研究组 & 干预措施
RC148 plus platinum-based chemotherapy
Experimental
干预措施: RC148 Injection plus Pemetrexed Disodium for Injection and Carboplatin Injection (Drug)
Tislelizumab plus platinum-based chemotherapy
Active Comparator
干预措施: Tislelizumab Injection plus Pemetrexed Disodium for Injection and Carboplatin Injection (Drug)
结局指标
主要结局
Progression-Free Survival assessed by BIRC per RECIST v1.1
时间窗: 24 months
次要结局
- Overall Survival(24 months)
- Objective Response Rate assessed by BIRC per RECIST v1.1(24 months)
- Duration of Response assessed by BIRC per RECIST v1.1(24 months)
- Disease Control Rate assessed by BIRC per RECIST v1.1(24 months)
- Time To Response assessed by BIRC per RECIST v1.1(24 months)
- Progression-Free Survival assessed by Investigator per RECIST v1.1(24 months)
- Objective Response Rate assessed by Investigator per RECIST v1.1(24 months)
- Duration of Response assessed by Investigator per RECIST v1.1(24 months)
- Disease Control Rate assessed by Investigator per RECIST v1.1(24 months)
- Time To Response assessed by Investigator per RECIST v1.1(24 months)
- Number of participants with adverse events as assessed by CTCAE v6.0 during treatment(24 months)
- Observed serum concentrations of RC148(24 months)
研究者
研究点 (1)
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