2024-517561-16-00招募中2 期
A multicenter phase II study of neoadjuvant sacituzumab govitecan plus zimberelimab followed by adjuvant zimberelimab with or without sacituzumab govitecan in patients with resectable non-small cell lung cancer (NeoTRACE) [without IMPD-Q]
AIO-Studien gGmbH14 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年9月22日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 14
- 主要终点
- Pathological complete response (pCR) rate in the resected primary tumor and all resected lymph nodes, defined as the proportion of patients whose resected samples are negative for residual viable tumor cells
研究概览
简要总结
To evaluate the effect of neoadjuvant Sacituzumab govitecan (SG) plus Zimberelimab (ZIM) on the pathological complete response (pCR) rate in patients with resectable NSCLC
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Patients ≥ 18 years of age at the time of informed consent signature.
- •Histological confirmed, resectable NSCLC, stage II to IIIB (N2) (UICC8), after completion of the full staging according to current guidelines including systematic mediastinal staging by EBUS and/or surgery, PD-L1 testing of tumor tissue, PET-CT, and cMRI.
- •Adequate hematologic counts without growth factor support within 2 weeks of study drug initiation (hemoglobin ≥ 9 g/dL, ANC ≥ 1500/mm3, and platelets ≥ 100,000/μL).
- •Adequate liver function (bilirubin ≤ 1.5 ULN, AST and ALT ≤ 2.5 x ULN)
- •Creatinine clearance ≥ 30 mL/min as assessed by the CKD-EPI method.
- •Patients are amenable to neoadjuvant treatment followed by surgery and adjuvant treatment.
- •Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
- •Female subjects of childbearing potential (WOCBP) must use highly effective contraceptive measures during the study and for 6 months after the last dose of study drug and must not be breast-feeding prior to start of trial. Non-child-bearing potential must be evidenced by fulfilling one of the following criteria at screening: a. Post-menopausal defined as aged more than 50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments b. Women under 50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and with LH and FSH levels in the post-menopausal range for the institution. c. Documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation.
排除标准
- •Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study, or during the follow-up period of an interventional study.
- •Must have recovered to grade ≤ 1 from all AEs due to previous therapies for other medical conditions. Patients participating in observational studies are eligible. Must have recovered from any previous surgical procedure prior to enrollment
- •Has previously received topoisomerase 1 inhibitors
- •Has an active second malignancy. Note: Patients with a history of malignancy that have been completely treated, with no evidence of active cancer for 3 years prior to enrollment, or patients with surgically cured tumors with low risk of recurrence (eg, nonmelanoma skin cancer, histologically confirmed complete excision of carcinoma in situ, or similar) are allowed to enroll.
- •Has an active chronic inflammatory bowel disease (ulcerative colitis, Crohn’s disease), or has a history of GI perforation within 6 months prior to enrollment.
- •Has an active serious infection requiring systemic therapy, or has a history of an active serious infection that required systemic therapy within 7 days prior to enrollment.
- •Female subjects who are pregnant or breast-feeding or patients of reproductive potential who are not employing a highly effective method of birth control (failure rate of less than 1% per year).
- •Medication that is known to interfere with any of the agents applied in the trial.
- •Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
- •Any condition or disease, which might interfere with the subject's ability to comply with the study procedures (e.g. dementia).
- •Has been incarcerated or involuntarily institutionalized by court order or by the authorities.
- •Has previously received topoisomerase 1 inhibitors.
- •Patients who are unable to consent because they do not understand the nature, significance and implications of the clinical trial and therefore cannot form a rational intention in the light of the facts.
- •Has an active second malignancy. Note: Patients with a history of malignancy that have been completely treated, with no evidence of active cancer for 3 years prior to enrollment, or patients with surgically cured tumors with low risk of recurrence (eg, nonmelanoma skin cancer, histologically confirmed complete excision of carcinoma in situ, or similar) are allowed to enroll.
- •Has an active chronic inflammatory bowel disease (ulcerative colitis, Crohn’s disease), or has a history of GI perforation within 6 months prior to enrollment.
- •Has an active serious infection requiring systemic therapy, or has a history of an active serious infection that required systemic therapy within 7 days prior to enrollment.
- •Female subjects who are pregnant or breast-feeding or patients of reproductive potential who are not employing a highly effective method of birth control (failure rate of less than 1% per year).
- •Medication that is known to interfere with any of the agents applied in the trial.
- •Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
- •Has received prior radiotherapy of the primary tumor and/or mediastinum.
结局指标
主要结局
Pathological complete response (pCR) rate in the resected primary tumor and all resected lymph nodes, defined as the proportion of patients whose resected samples are negative for residual viable tumor cells
Pathological complete response (pCR) rate in the resected primary tumor and all resected lymph nodes, defined as the proportion of patients whose resected samples are negative for residual viable tumor cells
次要结局
- Major pathological response (MPR) rate in the resected primary tumor and all resected lymph nodes (defined as the proportion of patients whose resected samples show 10% or less residual viable tumor cells)
- Objective response rate (ORR) following completion of neoadjuvant therapy assessed by imaging using RECIST 1.1. Surgical resection rate. Time to surgery following C4D1
- Disease-free survival, DFS (inclusion to any recurrence of disease or death from any cause in the intent-to-treat population)
- Overall survival, OS (inclusion to death from any cause in the intent-to-treat population). Adverse events, AE (CTCAE 5)
- Quality of life, QoL (EORTC-QLQ-C30 and EQ-5D-5L)
研究者
Katrin Krause
Scientific
AIO-Studien gGmbH
研究点 (14)
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