臨床研究等提出・公開システム

A phase II study of carboplatin and etopside plus durvalumab for previously-untreated extensive-stage small-cell lung cancer (ES-ECLC) patients with poor performance status (PS) (NEJ045A)

(NEJ045A)

Watanabe Satoshi

Niigata University Medical and Dental Hospital

1-754, Asahimachidori, Chuouku, Niigata-city, Niigata

satoshi7@med.niigata-u.ac.jp

Nozaki Koichiro

Niigata University Medical and Dental Hospital

1-754, Asahimachidori, Chuouku, Niigata-city, Niigata

+81-25-368-9325

knozaki@med.niigata-u.ac.jp

Not Recruiting

Jan. 21, 2021

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

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.

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.

Both

extensive disease small cell lung cancer

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.

Tolerability of durvalumab, carboplatin and etoposide

One year survival rate, safety, objective response rate, progression-free survival, overall survival, improvement rate of PS

+81-25-368-9343

Dec. 21, 2020

none