Randomized phase II clinical trial of cisplatin/carboplatin and etoposide (PE) alone or in combination with nivolumab as frontline therapy for extensive-stage small cell lung cancer (ES-SCLC): ECOG-ACRIN EA5161

Document Type

Article

Publication Date

6-15-2025

Publication Title

Cancer

Abstract

PURPOSE: Nivolumab showed durable responses in patients with small cell lung cancer (SCLC). A randomized phase II study investigating nivolumab plus cisplatin/carboplatin and etoposide (PE) versus PE for patients with untreated extensive-stage (ES) SCLC was conducted.

METHODS: Patients with untreated ES-SCLC, Eastern Cooperative Oncology Group performance status 0-1, were randomized 1:1 to nivolumab 360 mg intravenously (IV) plus cisplatin 75 mg/m

RESULTS: Overall, 160 patients were enrolled; 144 patients were treated and constituted the primary analysis. The median PFS was 5.5 months (95% confidence interval [CI], 4.3-5.9 months) on arm A, and 4.9 months (95% CI, 4.5-5.7 months) on arm B (hazard ratio, 0.78; p = .083). The estimated median OS was 11.2 months (95% CI, 8.8-14.2 months) on arm A and 8.1 months (95% CI, 7.2-9.6 months) on arm B (hazard ratio, 0.71; p = .059).

CONCLUSION: The combination of PE and nivolumab improves both PFS and OS for patients with ES-SCLC. No new safety signals were observed.

Medical Subject Headings

Humans; Small Cell Lung Carcinoma; Etoposide; Female; Carboplatin; Nivolumab; Male; Cisplatin; Antineoplastic Combined Chemotherapy Protocols; Middle Aged; Lung Neoplasms; Aged; Adult; Progression-Free Survival; Neoplasm Staging

PubMed ID

40526078

Volume

131

Issue

12

First Page

35938

Last Page

35938

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