Exploratory study evaluating the potential of immune signature profiling for predicting response in patients with resectable Stage II, IIIA and select IIIB (T3N2 only) non-squamous Non-Small Cell Lung Cancer (NSCLC) to neoadjuvant ATEZOLIZUMAB plus Carboplatin/Nab Paclitaxel (IReP)

Universitaetsklinikum Heidelberg AöR, Universitaetsklinikum Heidelberg AöR1 个研究点分布在 1 个国家目标入组 20 人2024年9月18日

概览

阶段: 2 期
干预措施: 未指定
疾病 / 适应症: 未指定
发起方: Universitaetsklinikum Heidelberg AöR, Universitaetsklinikum Heidelberg AöR
入组人数: 20
试验地点: 1
主要终点: Response to neoadjuvant immunochemotherapy with ATEZOLIZUMAB, Carboplatin and nab- Paclitaxel as determined by Major Pathologic Response (MPR) (≤10% residual viable tumor cells) (pathologic regression grading according to Junker criteria) rate
状态: 进行中（未招募）
最后更新: 去年

概览研究者入排标准结局指标研究点相似试验

概览

简要总结

To assess response in patients with NSCLC undergoing neoadjuvant ATEZOLIZUMAB investigational treatment in combination with Carboplatin and nab-Paclitaxel before NSCLC curative intent surgery.

注册库

euclinicaltrials.eu

开始日期

2024年9月18日

结束日期

待定

最后更新

去年

研究类型

Interventional clinical trial of medicinal product

研究者

发起方

Universitaetsklinikum Heidelberg AöR, Universitaetsklinikum Heidelberg AöR

责任方

Principal Investigator

主要研究者

Prof. Dr. med. Dirk Jäger

Scientific

Universitaetsklinikum Heidelberg AöR

入排标准

入选标准

•Willing and able to sign a written informed consent form (ICF)
•Females must have a negative serum pregnancy test (β -hCG) result at screening and agree to ongoing pregnancy testing during the course of the study, and after the end of study therapy.
•Male subjects must practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for 6 months following treatment discontinuation, even if he has undergone a successful vasectomy.
•adequate renal, hepatic, and bone marrow function as defined below
•Absolute neutrophil count (ANC) > 1500/μl
•Platelet count ≥ 100000/μl
•Hemoglobin ≥ 9 g/dl (can be post-transfusion)
•International normalized ratio (INR) ≤ 1.4 in patients not receiving anticoagulation; for patients receiving respective anticoagulation an INR ≤3.0 allowed
•Activated partial thromboplastin time (aPTT) ≤ 1.5 times upper limit of normal (ULN) in patients not receiving anticoagulation; for patients receiving respective anticoagulation a PTT ≤2.5 x ULN allowed
•Bilirubin < 1.5 times x ULN (for patients with known Gilbert disease Bilirubin ≤ 3 times x ULN allowed)

排除标准

•Illness or condition that may interfere with a patient’s capacity to understand, follow, and/or comply with study procedures
•Pregnant or lactating women
•Active autoimmune disease or history of severe autoimmune disease or immunodeficiency or a syndrome that requires systemic steroids or immunosuppressive agents
•The following exceptions are granted: o patients with vitiligo, eczema, lichen simplex or resolved childhood asthma/atopy o subjects requiring intermittent use of bronchodilatators or local steroid injections o patients with hypothyreoidism stable on hormone replacement
•Treatment with systemic immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, and anti-tumor necrosis factor (anti- TNF) agents) within 2 weeks prior to Cycle 1, Day 1 (except lowdose steroids for adrenal failure or emesis prophylaxis)
•History of idiopathic pulmonary fibrosis, interstitial lung disease, organizing pneumonia, drug-induced pneumonitis, or evidence of active pneumonitis on screening chest Computed Tomography (CT) scan
•Prior treatment with cluster of differentiation 137 (CD137) agonist or immune checkpoint blockade therapies, anti-programmeddeath- 1 (anti-PD-1), and anti-PD-L1 therapeutic antibody
•Live vaccine within 30 days prior to first dose of trial treatment
•Cerebrovascular accident within the past 6 months
•Severe infection or significant traumatic injury within the past 4 weeks

结局指标

主要结局

Response to neoadjuvant immunochemotherapy with ATEZOLIZUMAB, Carboplatin and nab- Paclitaxel as determined by Major Pathologic Response (MPR) (≤10% residual viable tumor cells) (pathologic regression grading according to Junker criteria) rate

次要结局

Response rate as determined by Δ tumor size and Δ lymph node size according to RECIST 1.1 criteria
Response rate as determined by Δ PETactivity (standardized uptake value [SUV])
Event-free survival (EFS) ● calculated from start of 1st cycle of neoadjuvant treatment ● follow-up for 24 months after end of treatment visit; end of treatment visit takes place 6 weeks after surgery
Overall survival (OS) ● calculated from start of 1st cycle of neoadjuvant treatment ● follow-up for 24 months after end of treatment visit; end of treatment visit takes place 2-6 weeks after surgery
Number of patients attaining surgery as planned