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Background <p>Extensive-stage small cell lung cancer (ES-SCLC) is characterized by a high risk of malignancy and a poor prognosis. This trial aimed to evaluate the efficacy and safety of envafolimab plus chemotherapy as a first-line treatment for ES-SCLC.</p> Methods <p>This prospective, single-arm, phase II trial was conducted at the Fifth Medical Center of Chinese PLA General Hospital. Eligible patients with histologically or cytologically confirmed ES-SCLC were consecutively enrolled. Patients were given four cycles of carboplatin (area under the curve of 5–6&#xa0;mg/mL/min, day 1 of each cycle) and etoposide (80–100&#xa0;mg/m<sup>2</sup> of body-surface area, on day 1–3 of each cycle) with envafolimab (300&#xa0;mg, Q3W, day 3 post-chemotherapy of each cycle), followed by envafolimab maintenance until disease progression or intolerable toxicity. The primary endpoint was progression-free survival (PFS).</p> Results <p>Between October 2021 and November 2022, a total of 32 patients were enrolled in this trial. A total of 32 patients were included in the safety analysis, and 31 patients were included in the efficacy analysis. As of the data cutoff (September 15, 2024), the median follow-up was 27.7&#xa0;months (IQR, 22.6–NA). The objective response rate (ORR) was 87.1% (95% CI, 70.2–96.4%), and the disease control rate (DCR)was 100% (95% CI, 88.8–100%). The median duration of response (DoR) was 5.47&#xa0;months (95% CI, 3.43–10&#xa0;months). The median progression-free survival (PFS) was 6.43&#xa0;months (95% CI, 4.83–7.67&#xa0;months), and median overall survival (OS) was 20&#xa0;months (95% CI, 14.7–NA). Treatment-related adverse events (TRAEs) of any grade were reported in 59.4% of patients, with grade ≥ 3 TRAEs reported in 15.6% of patients. No treatment-related deaths occurred. Additionally, findings from serum proteomic profiling demonstrated that specific immune-related proteins, including CCL3, CXCL10, HGF, and CXCL8, might be correlated with shorter survival and worse clinical outcomes.</p> Conclusions <p>Envafolimab combined with chemotherapy as a first-line treatment for ES-SCLC yielded favorable clinical efficacy with a manageable safety profile, indicating that it may be a promising treatment modality.</p> Trial registration <p>This trial was registered at chictr.org.cn (ChiCTR2100044981).</p>

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Efficacy, safety, and exploratory biomarker analysis of envafolimab plus carboplatin and etoposide as first-line treatment for extensive-stage small-cell lung cancer: a prospective, single-arm, phase II trial

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  • 发表日期：

    2025年10月6日

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  • Xiao Zhao,
  • Jing Zhang,
  • Lupeng Qiu,
  • Quanli Han,
  • Xiang Yan,
  • Yanyun Zhu,
  • Jinliang Wang,
  • Xiaoling Zhang,
  • Shunchang Jiao,
  • Shengjie Sun

摘要

Background

Extensive-stage small cell lung cancer (ES-SCLC) is characterized by a high risk of malignancy and a poor prognosis. This trial aimed to evaluate the efficacy and safety of envafolimab plus chemotherapy as a first-line treatment for ES-SCLC.

Methods

This prospective, single-arm, phase II trial was conducted at the Fifth Medical Center of Chinese PLA General Hospital. Eligible patients with histologically or cytologically confirmed ES-SCLC were consecutively enrolled. Patients were given four cycles of carboplatin (area under the curve of 5–6 mg/mL/min, day 1 of each cycle) and etoposide (80–100 mg/m2 of body-surface area, on day 1–3 of each cycle) with envafolimab (300 mg, Q3W, day 3 post-chemotherapy of each cycle), followed by envafolimab maintenance until disease progression or intolerable toxicity. The primary endpoint was progression-free survival (PFS).

Results

Between October 2021 and November 2022, a total of 32 patients were enrolled in this trial. A total of 32 patients were included in the safety analysis, and 31 patients were included in the efficacy analysis. As of the data cutoff (September 15, 2024), the median follow-up was 27.7 months (IQR, 22.6–NA). The objective response rate (ORR) was 87.1% (95% CI, 70.2–96.4%), and the disease control rate (DCR)was 100% (95% CI, 88.8–100%). The median duration of response (DoR) was 5.47 months (95% CI, 3.43–10 months). The median progression-free survival (PFS) was 6.43 months (95% CI, 4.83–7.67 months), and median overall survival (OS) was 20 months (95% CI, 14.7–NA). Treatment-related adverse events (TRAEs) of any grade were reported in 59.4% of patients, with grade ≥ 3 TRAEs reported in 15.6% of patients. No treatment-related deaths occurred. Additionally, findings from serum proteomic profiling demonstrated that specific immune-related proteins, including CCL3, CXCL10, HGF, and CXCL8, might be correlated with shorter survival and worse clinical outcomes.

Conclusions

Envafolimab combined with chemotherapy as a first-line treatment for ES-SCLC yielded favorable clinical efficacy with a manageable safety profile, indicating that it may be a promising treatment modality.

Trial registration

This trial was registered at chictr.org.cn (ChiCTR2100044981).