Randomized Phase III Multicenter Trial of RRM1 & ERCC1 Directed Customized Chemotherapy versus Standard of Care for 1st Line Treatment of Patients with Advanced Non-Small-Cell Lung Cancer - MADeIT

Klinik Loewenstein gGmbH0 个研究点目标入组 267 人开始时间: 2008年9月26日最近更新: 2012年8月14日

试验速览

暂无简介。

•- Histologically confirmed NSCLC of adenocarcinoma, squamous cell carcinoma, large cell carcinoma, or NSCLC not otherwise specified (NOS). Patients with suspected NSCLC may enroll prior to the diagnostic biopsy in order to obtain both the diagnostic and molecular analysis-required specimen during the same procedure.
•- Willing to undergo a biopsy to enable customization of chemotherapy
•- Stage IV or IIIB (malignant pleural effusion) NSCLC
•- Measurable or evaluable disease by RECIST (Therasse et al, JNCI 2000)
•- Age >= 18 years
•- Previous chemotherapy is allowed if the last dose was administered equal to or greater than 12 months ago. This chemotherapy must have been given in an adjuvant or neoadjuvant mode prior to or after a complete surgical resection (R0 resection) for a NSCLC.
•- Patients with stable brain metastases will be allowed to enroll.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•- Pregnant or lactating women
•- Prior systemic chemotherapy or immunotherapy for advanced NSCLC.
•- Prior malignancies, except: cured non-melanoma skin cancer; curatively treated in situ carcinoma of the cervix; any other curatively treated malignancy with no evidence of disease recurrence for at least 3 years
•- peripheral neuropathy or hearing loss of neural origin equal to or greater than grade 2 by CTCAE v3.0 except if due to trauma
•- patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80

发起方

Klinik Loewenstein gGmbH