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

Conditions

extensive disease small cell lung cancer

Asao T, Saida Y, Watanabe S, Kisohara A, Kishi K, Morita R, Nakagawa T, Tsukita Y, Furuya N, Miyawaki T, Ishikawa N, Yamada T, Tanaka T, Morita S, Kikuchi T, Maemondo M, Kobayashi K, North East Japan Study Group.

2025-09-28

10.1016/s2213-2600(25)00240-1

Safety and efficacy of durvalumab plus carboplatin and etoposide for patients with previously untreated extensive-stage small-cell lung cancer (ES-SCLC) with a poor performance status: The results from phase II single-arm study (NEJ045A study).

Yu Saida, Tetsuhiko Asao, Satoshi Watanabe, Akira Kisohara, Kazuma Kishi et al. (17 authors)

Journal of Clinical Oncology2024-06-014 citations

10.1200/jco.2024.42.16_suppl.8101

A phase II study of carboplatin and etoposide plus durvalumab for previously untreated extensive-stage small-cell lung cancer (ES-SCLC) patients with a poor performance status (PS): NEJ045A study protocol.

Asao T, Watanabe S, Tanaka T, Morita S, Kobayashi K.

2022-11-048 citations

10.1186/s12885-022-10222-1

Interventions

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 e

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

Measure	Time frame
Tolerability of durvalumab, carboplatin and etoposide	—

Secondary

Measure	Time frame
One year survival rate, safety, objective response rate, progression-free survival, overall survival, improvement rate of PS	—

Contacts

Public ContactKoichiro Nozaki

Niigata University Medical and Dental Hospital

knozaki@med.niigata-u.ac.jp+81-25-368-9325

Outcome results

None listed