Shanghai Henlius Biotech has dosed the first subject in the Phase III clinical trial of Hansizhuang (serplulimab) plus chemotherapy and radiotherapy for limited-stage small cell lung cancer (LS-SCLC) in Europe.
The first subject was dosed in Latvia.
The double-blind, randomised, global, multicentre trial is designed to analyse the safety and efficacy of serplulimab compared to placebo.
Subjects in both arms will receive chemotherapy comprising carboplatin/cisplatin-etoposide and simultaneous radiotherapy.
Assessing the anti-tumour activity of serplulimab plus chemotherapy and radiotherapy is the trial’s primary objective.
The primary endpoint of the study is overall survival while objective response rate, progression-free survival, duration of response, immunogenicity and safety will be the secondary endpoints.
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Henlius earlier dosed the first subjects in China, the US, Australia and other countries.
A recombinant humanised anti-PD-1 monoclonal antibody (mAb), Hansizhuang is approved by the China National Medical Products Administration for various oncology indications.
It is indicated for treating ES-SCLC, non-small cell lung cancer, oesophageal squamous cell carcinoma and microsatellite instability-high (MSI-H) solid tumours in China.
More than ten trials of Henlius’s Hansizhuang are underway globally.
In October last year, Henlius obtained the Spanish Agency of Medicines and Medical Devices approval for a Phase III trial of the pertuzumab biosimilar, HLX11.