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Clinical Trial
. 2024 Feb 12;42(2):198-208.e3.
doi: 10.1016/j.ccell.2023.12.004. Epub 2024 Jan 4.

A global phase 3 study of serplulimab plus chemotherapy as first-line treatment for advanced squamous non-small-cell lung cancer (ASTRUM-004)

Caicun Zhou  1 , Yanping Hu  2 , Ekaterine Arkania  3 , Saadettin Kilickap  4 , Kejing Ying  5 , Fei Xu  6 , Lin Wu  7 , Xiang Wang  8 , Maksym Viguro  9 , Tamta Makharadze  10 , Hongmei Sun  11 , Feng Luo  12 , Jianhua Shi  13 , Aimin Zang  14 , Yueyin Pan  15 , Zhendong Chen  16 , Zhongyao Jia  17 , Vladimer Kuchava  18 , Ping Lu  19 , Ling Zhang  20 , Ying Cheng  21 , Wenying Kang  22 , Qingyu Wang  22 , Haoyu Yu  22 , Jing Li  22 , Jun Zhu  22 ; ASTRUM-004 Investigators
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Free article
Clinical Trial

A global phase 3 study of serplulimab plus chemotherapy as first-line treatment for advanced squamous non-small-cell lung cancer (ASTRUM-004)

Caicun Zhou et al. Cancer Cell. .
Free article

Abstract

Combining immunotherapy with chemotherapy can provide improved survival in advanced squamous non-small-cell lung cancer (NSCLC) patients without targetable gene alterations. 537 previously untreated patients with stage IIIB/IIIC or IV squamous NSCLC without targetable gene alterations were enrolled and randomized (2:1) to receive serplulimab 4.5 mg/kg or placebo, both in combination with nab-paclitaxel and carboplatin, intravenously in 3-week cycles. The primary endpoint of progression-free survival (PFS) was met at the first interim analysis. At the second interim analysis, PFS benefit was maintained in serplulimab-chemotherapy group (hazard ratio [HR] 0.53, 95% confidence interval [CI] 0.42-0.67). At the final analysis, serplulimab-chemotherapy significantly improved median OS compared to placebo-chemotherapy (HR 0.73, 95% CI 0.58-0.93; p = 0.010). Grade ≥3 serplulimab or placebo-related adverse events occurred in 126 (35.2%) and 58 (32.4%) patients, respectively. Our results demonstrate that adding serplulimab to chemotherapy significantly improves survival in advanced squamous NSCLC patients, with manageable safety.

Trial registration: ClinicalTrials.gov NCT04033354.

Keywords: PD-1; PD-L1; first-line; phase 3; serplulimab; squamous non-small-cell lung cancer.

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Conflict of interest statement

Declaration of interests C.Z. reports receiving honoraria as a speaker from Lilly China, Sanofi, Boehringer Ingelheim, Roche, Merck Sharp & Dohme, Qilu Pharmaceutical, Jiangsu Hengrui Pharmaceuticals, Innovent Biologics, CStone Pharmaceuticals, Luye Pharma, TopAlliance Biosciences, and Amoy Diagnostics; and serving as an advisor for Innovent Biologics, Jiangsu Hengrui Pharmaceuticals, Qilu Pharmaceutical, and TopAlliance Biosciences. W.K., Q.W., H.Y., J.L., and J.Z. are employees of Shanghai Henlius Biotech, Inc.

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