NIPH Clinical Trials Search

Basic Information

Recruitment status	Not Recruiting
Health condition(s) or Problem(s) studied	extensive disease small cell lung cancer
Date of first enrollment	08/04/2021
Target sample size	56
Countries of recruitment
Study type	Interventional
Intervention(s)	Induction therapy: Durvalumab 1500 mg/body day1 + carboplatin (PS 2: AUC 4, PS 3: AUC 3) day1 + etoposide (PS 2: 80 mg/m2, PS 3: 60mg/m2) day1 q3 - 4w. The doses can be titrated according to adverse events in the previous cycle. Maintenance therapy: Durvalumab 1500 mg/body day1 q4w.

Outcome(s)

Primary Outcome	Tolerability of durvalumab, carboplatin and etoposide
Secondary Outcome	One year survival rate, safety, objective response rate, progression-free survival, overall survival, improvement rate of PS

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	Not applicable
Gender	Both
Include criteria	1) Extensive stage small cell lung cancer proven by histology and/or cytology without indication of curative surgery or curative radiotherapy, 2) No prior cytotoxic chemotherapy or immunotherapy, 3) ECOG PS 2 or 3, 4) 20 years or older, 5)Measurable disease, as defined by RECIST ver 1.1, 6) adequate hematologic and end organ function,7) Written informed consent form.
Exclude criteria	1) History of interstitial lung disease, 2) Symptomatic CNS metastases, CNS metastases treated with corticosteroids, leptomeningeal disease, 3) Irradiation for primary tumor or target lesion defined by RECIST ver1.1, 4) Uncontrolled heart, lung, liver, renal diseases, 5) History of autoimmune diseases or immunodeficiency, 6) Patients with active hepatitis B or hepatitis C or positive for HIV test, 7) Men without an intention to use the measure for contraception or women who are pregnant, lactating, or intending to become pregnant during the study, 8) Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures, 9) Malignancies other than NSCLC within 5 years, 10) Systemic steroid administration at a dose of more than 10 mg of prednisolone for 4 weeks or longer.