NCT07383116

Phase III Clinical Study of HB0025 Combined With Chemotherapy Versus Tislelizumab Combined With Chemotherapy as First-Line Treatment for Advanced Nonsquamous Non-Small Cell Lung Cancer

A Randomized, Double-Blind, Multicenter Phase III Clinical Study of HB0025 Injection Combined With Chemotherapy Versus Tislelizumab Combined With Chemotherapy as First-Line Treatment for Locally Advanced or Metastatic Nonsquamous Non-Small Cell Lung Cancer

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Shanghai Huaota Biopharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a randomized, controlled, double-blind, multicenter Phase III registration clinical trial, aiming to evaluate the efficacy and safety of HB0025 combined with chemotherapy (pemetrexed plus carboplatin/cisplatin) versus tislelizumab combined with chemotherapy (pemetrexed plus carboplatin/cisplatin) as a first-line treatment for unresectable locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) nonsquamous non-small cell lung cancer (NSCLC). The study will take progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR) as the primary endpoint, and plans to enroll approximately 500 subjects. After being eligible for screening, patients will be randomly assigned to the study groups at a ratio of 1:1 to receive either HB0025 combined with chemotherapy (experimental group) or tislelizumab combined with chemotherapy (control group). Both regimens will be administered once every 3 weeks (Q3W). After completing 4 cycles of treatment, patients will enter the maintenance therapy phase with HB0025 or tislelizumab plus pemetrexed (Q3W). The treatment will last until the investigator determines that there is no longer clinical benefit (based on comprehensive assessment of RECIST v1.1 imaging results and clinical symptoms), intolerable toxicity occurs, 35 cycles of study treatment are completed, or other treatment termination criteria specified in the protocol are met, whichever comes first.

Detailed description

The random stratification factors of this study are as follows: Disease stage (Stage IIIB/IIIC vs Stage IV); PD-L1 expression score indicator (Tumor Proportion Score, TPS): \<1%, 1%-49%, ≥50%; Hepatic or brain metastasis (Yes vs No). This trial adopts the RECIST v1.1 criteria to conduct regular tumor response assessments for the subjects. Within 1 year (365 days) after the first dose, tumor assessments will be performed at Week 6 (±7 days), Week 12 (±7 days), and then every 9 weeks (±7 days) thereafter; after 1 year, assessments will be conducted every 12 weeks (±7 days). If a subject discontinues study treatment due to reasons other than disease progression or death, tumor assessments should continue according to the fixed schedule until disease progression or study termination (whichever occurs later), initiation of new anti-tumor therapy, loss to follow-up, death, withdrawal of informed consent, or study completion, whichever occurs first. At least 4 weeks after the first documentation of objective response, the objective response should be confirmed by re-assessment (in cases of clinical stability, the confirmation can be performed at the next scheduled assessment time point). After the first documented radiological progression, if the investigator determines that the subject can still benefit from continued treatment and meets the criteria for continued treatment specified in the protocol, the subject may maintain the original treatment regimen until no clinical benefit is observed (assessed by the investigator). If a subject withdraws from the study treatment due to reasons other than those mentioned above (e.g., occurrence of intolerable adverse events, completion of 24 months of HB0025 or tislelizumab treatment, or other reasons necessitating treatment discontinuation), a tumor assessment should be performed prior to study termination. The investigator may conduct unscheduled tumor assessments (with an interval of at least 4 weeks from the previous assessment) when disease progression is suspected or other necessary circumstances arise. The sponsor will collect all imaging data of the subjects for BICR assessment.

Conditions

• Non Squamous Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Pemetrexed injection	500 mg/m², Q3W.
DRUG	Carboplatin Injection	AUC 5, Q3W.
DRUG	Cisplatin injection	75 mg/m², Q3W.
DRUG	HB0025 Injection	HB0025 Injection, ivgtt, Q3W，developed by Sponsor Huaota.
DRUG	Tislelizumab	Tislelizumab, Active Control, intravenous infusion, once every 3 weeks (Q3W)

Timeline

• Start date: 2026-01-15
• Primary completion: 2028-04-10
• Completion: 2028-04-10
• First posted: 2026-02-03
• Last updated: 2026-02-03

Locations

1 site across 1 country: China