A Phase II/III Randomized Trial of Two Doses of MK-3475 versus Docetaxel in Previously Treated Subjects with NSCLC
Treatment of subjects with NSCLC whose tumors are positive for PD-L1 and have experienced disease progression after a platinum-containing systemic treatment. The purpose of this study is to test the safety and tolerability of the research study drug MK-3475 and to test the effectiveness of the study drug to standard care Docetaxel. Nationwide, 520 to 920 patients will be recruited for this study. At Rush University Medical Center, we expect to recruit approximately 10 patients.
You may be eligible to participate in this study if you:
- Have stage IIIb or IV NSCLC with positive PD-L1
- Have progressed with platinum-containing treatment
- Must know or have tissue tested for EGFR and ALK mutation. If EGFR+ - must have also been on a EGFR tyrosine kinase inhibitor. If ALK+ - must have been on crizotinib
You will be excluded from this study if you:
- Have received prior treatment with Docetaxel for NSCLC
- Have had a previous malignancy within the past five years (exception — basal cell carcinoma, squamous cell carcinoma of the skin, superficial bladder cancer or in situ cervical cancer)
- Have active or a history of autoimmune disease
- Have a history of organ transplant
- Are pregnant or lactating
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.