An, open label, randomized, clinical trial of Mycobacterium w (Mw) as an Adjuvant to chemotherapy in Advanced Non-small Cell Lung Cancer - Mycidac Study

Tata Memorial Hospital0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1 Patients willing to comply with the protocol and have signed IEC or IRB approved informed consent form (ICF).
•2 Histologically confirmed Stage IIIb/IV NSCLC patients (as per AJCC Classification) without any driver mutation planned with treatment with palliativecare
•3 Eligible for cytotoxic combination chemotherapy as a first linetherapy
•4 Male or female patient aged 18-years or more; Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; and Life Expectancy of at least 24weeks
•5 Adequate organ function as evidenced by hematological and biochemical tests.
•6 Negative pregnancy test for women of child bearing potential prior to entry into the trial. Women of childbearing potential or men with partners of childbearing potential must use effective physical contraceptive measures during treatment and at least 6 months after the last dose of the study treatment. If a woman becomes pregnant or suspects she is pregnant while participating in this study, she must agree to inform her treating physician immediately.

•1 Patients with untreated symptomatic brain metastasis. Patients with symptomatic brain mets after receiving RT to brain can be included in the study
•2 Malignancy other than NSCLC within 5 years prior to enrollment, with the exception of basal cell carcinoma or carcinoma insitu of the cervix.
•3 History of allergic reactions attributed to paclitaxel, platinum based chemotherapy or mycobacteria or any of their ingredients
•4 Pregnant women or nursingwomen
•5 Uncontrolled inter- current illness that would limit compliance with study requirements
•6 HIV positive patients with CD4 count less than 200
•7 Previous splenectomy
•8 A major surgical procedure, or significant traumatic injury <=28 days of beginning treatment, or anticipation of the need for major surgery during the course of thestudy
•9 Current, recent, or planned participation in another experimental drug study
•10 Patients who had cytotoxic chemotherapy and/or radiotherapy (except palliative radiotherapy within 2 weeks prior to enrollment)

发起方