RANDOMIZED, MULTICENTER, DOUBLE-BLIND, PHASE 3 TRIAL COMPARING THE EFFICACY OF IPILIMUMAB IN ADDITION TO PACLITAXEL AND CARBOPLATIN VERSUS PLACEBO IN ADDITION TO PACLITAXEL AND CARBOPLATIN IN SUBJECTS WITH STAGE IV/RECURRENT NON-SMALL CELL LUNG CANCER (NSCLC).

BRISTOL MYERS SQUIBB COMPANY,0 个研究点目标入组 5 人开始时间: 2011年10月17日最近更新: 2023年9月4日

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•1) SIGNED WRITTEN INFORMED CONSENT
•A) WILLING AND ABLE TO PROVIDE INFORMED CONSENT
•2) TARGET POPULATION
•A) SUBJECTS WITH NSCLC OF PREDOMINANTLY SQUAMOUS HISTOLOGY DOCUMENTED BY HISTOLOGY OR CYTOLOGY FROM BRUSHING, WASHING OR NEEDLE ASPIRATION OF A DEFINED ESION BUT NO FROM SPUTUM CYTOLOGY ALONE. DIAGNOSIS TO BE SUPPORTED BY AT LEAST 1 IMMUNO-HISTOCHEMISTRY STAINING.
•B) SUBJECTS MUST PRESENT WITH STAGE IV OR RECURRENT NSCLC (PER THE 7TH INTERNATIONAL ASSOCIATION FOR THE STUDY OF LUNG CANCER (IASLC) CLASSIFICATION)
•C) AT LEAST 1 MEASURABLE TUMOR LESION, AS DEFINED BY mWHO CRITERIA, THAT IS NOT LOCATED IN A PREVIOUSLY IRRADIATED AREA.
•D) EASTERN COOPERATIVE ONCOLOGY GROUP (ECOG) PERFORMANCE STATUS ≤ 1 AT STUDY ENTRY.
•E) ACCESSIBLE FOR TREATMENT AND FOLLOW-UP. SUBJECTS ENROLLED IN THIS TRIAL MUST BE TREATED AT THE PARTICIPATING CENTERS.
•3) AGE AND REPRODUCTIVE STATUS
•A) MEN AND WOMEN ≥ 18 YEARS OF AGE.
•B) WOMEN OF CHILDBEARING POTENTIAL (WOCBP)(MUST BE USING AN ACCEPTABLE METHOD OF CONTRACEPTION TO AVOID PREGNANCY THROUGHOUT THE STUDY AND FOR UP TO 8 WEEKS AFTER THE LAST DOSE OF IPILIMUMAB IN SUCH A MANNER THAT THE RISK OF PREGNANCY IS MINIMIZED. SEE SECTION 3.3.3 FOR THE DEFINITION OF WOCBP.

•1) TARGET DISEASE EXCEPTIONS
•A) BRAIN METASTASES
•B) MALIGNANT PLEURAL EFFUSION THAT IS RECURRENT DESPITE APPROPRIATE SUPPORTIVE CARE.
•2) MEDICAL HISTORY AND CONCURRENT DISEASES
•A) DOCUMENTED HISTORY OF SEVERE AUTOIMMUNE OR IMMUNE MEDIATED SYMPTOMATIC DISEASE THAT REQUIRED PROLONGED (MORE THAN 2 MONTHS) SYSTEMIC IMMUNOSUPPRESIVE (ie, STEROIDS) TREATMENT SUCH AS:
•I) ULCERATIVE COLITIS AND CROHN´S DISEASE
•II) RHEUMATOID ARTHRITIS, SYSTEMIC PROGRESSIVE SCLEROSIS (SCLERODERMA)
•III)SYSTEMIC LUPUS ERYTHEMATOSUS
•IV) AUTOIMMUNE VASCULITIS (eg, WEGENER´S GRANULOMATOSIS)
•B) SUBJECTS WITH HISTORY OF MOTOR NEUROPATHY CONSIDERED OF AUTOIMMUNE ORIGIN (eg., GUILLAIN-BARRE SYNDROME)
•C) SUBJECTS WITH A HISTORY OF TOXIC EPIDERMAL NECROLYSIS (TEN)
•D) DEMENTIA, ALTERED MENTAL STATUS, OR ANY PSYCHIATRIC CONDITION THAT WOULD PROHIBIT THE UNDERSTANDING OR RENDERING OF INFORMED CONSENT OR COMPLETING QUESTIONNAIRES.
•E) SRIOUS UNCONTROLLED MEDICAL DISORDER THAT, IN THE OPINION OF THE INVESTIGATOR, WOULD IMPAIR THE ABILITY OF THE SUBJECT TO RECEIVE PROTOCOL THERAPY.

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