The study consists of two parts:
Part I is a randomized, double-blind, multicenter, parallel-controlled phase II clinical study to evaluate the efficacy and safety of HLX07 in combination with serplulimab and chemotherapy versus placebo in combination with serplulimab and chemotherapy as first-line treatment in patients with sqNSCLC.
Part II is a randomized, double-blind, multicenter, parallel-controlled phase III clinical study to evaluate the efficacy and safety of HLX07 in combination with serplulimab and chemotherapy versus placebo in combination with pembrolizumab and chemotherapy as first-line treatment in patients with sqNSCLC.
The patients voluntarily participate in this clinical study, fully understand and have been informed about the study, have signed the informed consent form (ICF), and are willing to follow and able to complete all study procedures.
Male or female, aged 18 years or older at the time of signing the ICF.
Histologically confirmed with stage IIIB/IIIC or IV (AJCC 8th edition) squamous NSCLC ineligible for surgery or radical radiotherapy.
Patients must provide sufficient tumor tissues that meet the quality requirements for the determination of EGFR and PD-L1 expression levels.
Histologically confirmed non-sqNSCLC. Mixed tumors will be classified by the predominant cell type. Patients with small cell component or neuroendocrine carcinoma component are not eligible. For the non-small cell histology, patients with squamous component that is predominant (e.g., adenosquamous) are eligible.
Known EGFR-sensitizing mutation, ALK/ROS1 gene rearrangement, or other actionable driver oncogenes for which there are locally approved targeted first-line therapies.
Other malignancies within 5 years or active. Patients with localized tumors that have been cured, such as basal cell carcinoma, squamous-cell skin cancer, superficial bladder carcinoma, prostate carcinoma in situ, cervical carcinoma in situ, and breast cancer in situ, are eligible.
Scheduled or previous organ or bone marrow transplantation.