A Phase IIb/III randomized, double-blind, placebo-controlled study comparing first-line therapy with or without TG4010 immunotherapy product in patients with stage IV non-small cell lung cancer (NSCLC). - TIME study

Transgene S.A.0 个研究点目标入组 222 人2011年7月22日

适应症Stage IV non small cell lung cancer (NSCLC)MedDRA version: 19.0Level: LLTClassification code 10025055Term: Lung cancer non-small cell stage IVSystem Organ Class: 100000004864 MedDRA version: 19.0Level: LLTClassification code 10025048Term: Lung cancer non-small cell recurrentSystem Organ Class: 100000004864 Therapeutic area: Diseases [C] - Cancer [C04]

概览

阶段: 1 期
干预措施: 未指定
疾病 / 适应症: Stage IV non small cell lung cancer (NSCLC)
发起方: Transgene S.A.
入组人数: 222
状态: 进行中（未招募）
最后更新: 5年前

概览研究者入排标准结局指标相似试验

概览

简要总结

暂无简介。

注册库

who.int

开始日期

2011年7月22日

结束日期

2015年7月6日

最后更新

5年前

研究类型

Interventional clinical trial of medicinal product

性别

All

研究者

发起方

Transgene S.A.

入排标准

入选标准

•\- Male or female patients, age \= 18 years old
•\- Histologically confirmed NSCLC. NSCLC Not Otherwise Specified (NOS) are eligible except large cell neuroendocrine carcinoma.
•\- Stage IV cancer according to TNM classification
•\- Availability of histological material for Immunohistochemistry (IHC) staining on fixed paraffin embedded material; biopsy may come either from the primary tumor or from a metastasis
•\- Patient's naïve to first\-line therapy for the advanced stage of the disease. Previous neoadjuvant or adjuvant therapy or radiotherapy is allowed for patients who successfully underwent complete radical surgery and if last treatment was administered more than 12 months prior to the start of the study treatment, i.e., D1 of Cycle 1\.
•\- At least one measurable lesion by computorized tomography scan or magnetic resonance imaging based on RECIST version 1\.1 (CT is preferred for the chest exam)
•\- Performance status 0 or 1 on the ECOG scale
•\- Adequate hematological, hepatic, and renal function:
•\* Hemoglobin \= 10\.0 g/dL
•\* White Blood Cells \= 3\.0x1E\+09/L including:

排除标准

•\- NSCLC with predominant squamous cell histology (mixed tumors will be categorized by the predominant cell type unless small cell elements are present, in which case the patient is not eligible). Large cell neuroendocrine carcinoma are excluded
•\- Patients having Central Nervous System (CNS) metastases (including leptomeningeal metastases). Patients who have had brain metastases surgically removed or irradiated with no residual disease confirmed by imaging and not treated by corticosteroids are allowed are allowed
•\- EGFR activating mutations or ALK rearrangements leading to eligibility for TKI treatment (tests mandatory). Patients with documented ROS1\-rearrangement (if already tested) are not eligible
•\- Prior history of other malignancy except:
•\* Basal cell carcinoma of the skin
•\* Cervical intra epithelial neoplasia
•\* Other cancer curatively treated with no evidence of disease for at least 5 years
•\- Patients under chronic treatment with systemic corticoids or other immunosuppressive drugs (e.g., cyclosporine) for a period of at least 4 weeks and whose treatment was not stopped 1 week prior to the start of the study treatment (i.e., D1 of Cycle 1\)
•\- Positive serology for Human Immunodeficiency Virus or Hepatitis C Virus; presence in the serum of the antigens HBs
•\- Patient with any underlying medical condition that the treating physician considers might be aggravated by treatment or which is not controlled (e.g., elevated troponin or creatinine, uncontrolled diabetes)