RANDOMIZED, MULTICENTER, DOUBLE-BLIND, PHASE 3 TRIAL COMPARING THE EFFICACY OF IPILIMUMAB PLUS ETOPOSIDE/PLATINUM VERSUS ETOPOSIDE/PLATINUM IN SUBJECTS WITH NEWLY DIAGNOSED EXTENSIVE-STAGE DISEASE SMALL CELL LUNG CANCER (ED-SCLC)

BRISTOL MYERS SQUIBB COMPANY,0 个研究点目标入组 0 人开始时间: 2012年9月28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 SCLC DOCUMENTED BY HISTOLOGY OR CYTOLOGY FROM BRUSHING, WASHING OR NEEDLE ASPIRATION OF A DEFINED LESION BUT NOT FROM SPUTUM CYTOLOGY ALONE.
•B) SUBJECTS MUST PRESENT WITH EXTENSIVE STAGE DISEASE (VALG CLASSIFICATION).
•C) EASTERN COOPERATIVE ONCOLOGY GROUP (ECOG) PERFORMANCE STATUS ≤ 1.
•D) 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 OFCHILDBEARING POTENTIAL (WOCBP) AND MEN MUST BE USING AN ACCEPTABLE METHOD OF CONTRACEPTION TO AVOID PREGNANCY THROUGHOUT THE STUDY AND FOR UP TO 12 WEEKS AFTER THE LAST DOSE OF STUDY DRUG IN SUCH A MANNER THAT THE RISK OF PREGNANCY IS MINIMIZED. SEE SECTION 3.3.3 FOR THE DEFINITION OF WOCBP.
•C) WOCBP MUST HAVE A NEGATIVE SERUM OR URINE PREGNANCY TEST (MINIMUM SENSITIVITY 25 IU/L OR EQUIVALENT UNITS OF HCG) WITHIN 72 HOURS PRIOR TO THE START OF INVESTIGATIONAL PRODUCT.
•D) WOMEN MUST NOT BE BREASTFEEDING.

•1) TARGET DISEASE EXCEPTIONS
•A) CNS METASTASES, UNLESS NON-SYMPTOMATIC (IE, NO NEUROLOGICAL DEFICIT, EPILEPSY OR OTHER SIGNS AND SYMPTOMS TYPICAL OF CNS METASTASES), AND NOT REQUIRING TREATMENT WITH STEROIDS OR ANTICONVULSANT MEDICATIONS. IN ADDITION, IF TREATED WITH RADIATION THERAPY, CNS METASTASES MUST BE STABLE WITH NO EVIDENCE OF PROGRESSION ON SCANS FOR AT LEAST 30 DAYS FROM INITIAL RADIOLOGIC DIAGNOSIS OF CNS 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 IMMUNOSUPPRESSIVE (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) INTERSTITIAL PNEUMONIA OR PULMONARY FIBROSIS.
•E) PARANEOPLASTIC AUTOIMMUNE SYNDROME•

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