NCT07550920尚未招募2 期
Efficacy and Safety of Rilapentib Alpha Combined With Monotherapy Chemotherapy for the Perioperative Treatment of Resectable Stage II-III Driver Gene-Negative Non-Small Cell Lung Cancer (NSCLC): A Single-Center Phase II Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 18
- 主要终点
- Pathological Complete Response (pCR) Rate
研究概览
简要总结
This is a single-center, single-arm, phase 2 trial evaluating the efficacy and safety of retlirafusp alfa combined with single-agent chemotherapy as neoadjuvant treatment for patients with resectable stage II-III EGFR/ALK wild-type non-small cell lung cancer (NSCLC).Eligible patients receive 4 cycles of neoadjuvant therapy, followed by curative surgery and 1-year maintenance therapy with retlirafusp alfa.Primary endpoints are pathological complete response (pCR) rate and safety. Secondary endpoints include major pathological response (MPR), event-free survival (EFS), and overall survival (OS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Age 18-75 years
- •ECOG Performance Status 0-1;
- •Treatment-naive patients with histologically or cytologically confirmed NSCLC (via biopsy) and radiologically confirmed Stage II-III disease;
- •Patients with adenocarcinoma must be confirmed to be free of driver gene mutations such as EGFR or ALK; patients with squamous cell carcinoma do not require genetic testing;
- •Patients must have measurable lesions;
- •Patients whose disease was assessed as CR, PR, or SD following 2 cycles of neoadjuvant chemotherapy with Rilpufan α in combination with a single-agent non-platinum chemotherapy;
- •Life expectancy of at least 12 weeks;
- •Good function of other major organs (liver, kidneys, hematopoietic system, etc.): - Hemoglobin ≥ 9.0 g/dL (this level may be maintained or exceeded through blood transfusion); - Red blood cell count ≥ 2.0 × 10⁹/L; - Absolute neutrophil count (ANC) ≥ 1.0 × 10⁹/L; - Platelet count ≥ 100 × 10⁹/L; - Total bilirubin within normal limits; - Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase ≤ 2.5 times the upper limit of normal; - Creatinine ≤ 2.0 mg/dL; and creatinine clearance ≥ 60 mL/min; - For patients who have not received anticoagulant therapy: International Normalized Ratio (INR) for prothrombin time ≤ 1.5, and activated partial thromboplastin time (APTT) ≤ 1.5 times the upper limit of normal. Patients receiving full-dose or parenteral anticoagulant therapy may be enrolled in the clinical trial provided that the anticoagulant dose has been stable for at least 2 weeks prior to study entry and the results of coagulation tests fall within the limits established by the local treatment center.
- •No systemic metastases;
- •Expected to be completely resectable;
- •Good pulmonary function sufficient to tolerate surgical treatment;
- •Women of childbearing potential must undergo a pregnancy test within 7 days prior to the start of treatment and receive a negative result;
- •Participants must use reliable contraception (e.g., intrauterine device, oral contraceptives, and condoms) during the trial and for 30 days after its completion; 14 Participants voluntarily enroll in the study, sign an informed consent form, demonstrate good compliance, and cooperate with follow-up.
排除标准
- •Any systemic anticancer therapy for NSCLC, other than neoadjuvant therapy as specified in the inclusion criteria, including surgery, local radiotherapy, cytotoxic drug therapy, targeted drug therapy, and experimental treatments;
- •Patients who have had a cancer other than NSCLC within five years prior to the start of this trial;
- •Patients with unstable systemic diseases, such as uncontrolled hypertension or severe arrhythmias;
- •Patients with active, known, or suspected autoimmune diseases;
- •Patients with a history of or current interstitial lung disease;
- •Patients with HIV infection;
- •Patients who have undergone major systemic surgery or suffered severe trauma within 2 months prior to the start of this trial;
- •Pregnant or breastfeeding women;
- •Patients with neurological or psychiatric disorders who are unable to comply with the study protocol;
- •Other circumstances deemed unsuitable for enrollment by the investigator
研究组 & 干预措施
Experimental: Retlirafusp alfa + Single-agent Chemotherapy
Experimental
干预措施: Drug: Retlirafusp alfa (Drug)
Experimental: Retlirafusp alfa + Single-agent Chemotherapy
Experimental
干预措施: Drug: Single-agent Chemotherapy (Drug)
Experimental: Retlirafusp alfa + Single-agent Chemotherapy
Experimental
干预措施: Procedure: Radical Surgery (Other)
结局指标
主要结局
Pathological Complete Response (pCR) Rate
时间窗: Assessed at the time of surgery, approximately 6-8 weeks after completion of neoadjuvant therapy.
次要结局
- Pathological Response (PR) Rate(Assessed at the time of surgery.)
- Major Pathological Response (MPR) Rate(Assessed at the time of surgery.)
- Event-Free Survival (EFS)(Assessed from randomization up to 36 months post-surgery.)
- Overall Survival (OS)(From the start of randomization until the study end date (expected January 30, 2028))
- R0 resection rate(Assessment within 24 hours after surgery)
- Changes in EORTC QLQ-C30 Scores(Baseline; before each cycle of neoadjuvant therapy; at the time of surgery; 3, 6, and 12 months post-surgery)
- Recurrence-Free Survival (RFS)(Assessed from surgery up to 5 years post-surgery.)
- Number of positive lymph nodes(Assessment will be conducted after the surgery, once the pathology report is available.)
- Incidence of severe postoperative complications (Clavien-Dindo classification ≥ Grade III)(Continuous monitoring from the time of surgery through 30 days postoperatively.)
- Incidence and severity of adverse events (CTCAE v6.0)(The period is calculated from the first administration of the study drug until 30 days after the last dose; for delayed adverse reactions, the period is calculated until 1 year after the last dose.)
- Percentage of patients whose dosage was adjusted due to adverse events(Calculated from the start of the first treatment with the study drug until 30 days after the last dose.)
- Changes in EORTC QLQ-LC13 Scores(Baseline; before each cycle of neoadjuvant therapy; at the time of surgery; 3, 6, and 12 months post-surgery.)
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