This study is a randomized, controlled, double-blind, multi-center phase III registration clinical trial, aiming to observe, compare and evaluate the efficacy and safety of HB0025 combined with paclitaxel + carboplatin compared with pembrolizumab combined with paclitaxel + carboplatin as the first-line treatment for locally advanced or metastatic squamous NSCLC.
The study subjects are patients with locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) who have not received systemic anti-tumor treatment before. The study will use the PFS evaluated by BICR as the primary endpoint, and plan to enroll approximately 480 subjects, with the proportion of locally advanced subjects not exceeding 10%.
The subjects were fully informed and signed the informed consent form. If they met the inclusion criteria but did not meet the exclusion criteria, they were randomly assigned in a 1:1 ratio to receive HB0025 combined with chemotherapy Paclitaxel plus Platinum (experimental group) or pembrolizumab combined with chemotherapy Paclitaxel plus Platinum (control group). Both were administered once every 3 weeks (Q3W). After 4 cycles of treatment, Enter HB0025 or pembrolizumab monotherapy maintenance treatment (Q3W) until the investigator determines that there is no longer any clinical benefit (based on the RECIST v1.1 imaging assessment and comprehensive clinical symptom assessment by the investigator), intolerable toxicity occurs, 24 months of study treatment is completed, or other treatment termination criteria in the protocol are met. Whichever occurs first shall prevail.
Able to fully understand and voluntarily sign the informed consent form, and willing and able to comply with the clinical study procedures and follow-up visits.
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-1.
Expected survival ≥ 12 weeks.
Histologically or cytologically confirmed locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) non-small cell lung cancer (NSCLC) (confirmed per the 9th Edition of the TNM Staging System for Lung Cancer by the Union for International Cancer Control [UICC] and the American Joint Committee on Cancer [AJCC]) that is inoperable for radical resection and ineligible for radical concurrent/sequential chemoradiotherapy or immunotherapy as consolidation treatment.
Histologically confirmed presence of any small cell carcinoma, neuroendocrine carcinoma, or sarcoma components [mixed-type NSCLC (e.g., adenosquamous carcinoma) is permitted for enrollment].
Known presence of driver gene alterations with approved first-line therapeutic options, such as sensitive EGFR mutations, ALK fusion, ROS1 fusion, BRAF V600 mutation, NTRK fusion, MET exon 14 skipping mutation, or RET fusion.
History of a second primary malignancy within 3 years before Randomization (enrollment is permitted for other malignancies cured by local treatment, e.g., carcinoma in situ of the cervix, localized cutaneous squamous cell carcinoma, basal cell carcinoma, ductal carcinoma in situ of the breast, < T1 urothelial carcinoma, and papillary microcarcinoma of the thyroid).
No increase in lesion size or new lesions after treatment; ② No history of intracranial hemorrhage;
Parallel
Carboplatin Injection
Drug10mL:100mL, Q3W
Paclitaxel Injection
Drug5ml:30mg, Q3W
Progression-free survival (PFS)
PFS is defined as the time from the date of randomization till the first documentation of disease progression (per RECIST v1.1 criteria) assessed by the investigator or death due to any cause (whichever occurs first)
Overall Survival (OS)
OS is defined as the period from the start of randomization to the time of death due to any cause according to RECIST 1.1.
Objective Response Rate (ORR)
ORR is defined as the proportion of subjects achieving the best overall therapeutic effect (BOR) as complete remission (CR) or partial remission (PR) according to RECIST 1.1 by investigator.
Disease control rate (DCR)
DCR defined as the number of patients were confirmed CR and/or PR and/or stable disease(SD) according to RECIST 1.1 by investigator divided by the patients with at least one tumour evaluation
Duration of response (DOR)
DOR is defined as the time from the first record of CR or PR to the first record of disease. DOR as evaluated by investigators according to RECIST v1.1.
PD-L1 expression
Exploring the correlation between the levels of biomarkers (PD-L1) and the efficacy of combined treatment by Immunohistochemistry.
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