Phase III Clinical Study of HB0025 Combined With Chemotherapy Versus Tislelizumab Combined With Cā¦ (NCT07383116) | Clinical Trial Compass
Not Yet RecruitingPhase 3
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
China500 participantsStarted 2026-01-15
Plain-language 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.
Who can participate
Age range18 Years ā 75 Years
SexALL
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Inclusion criteria
ā. 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.
ā. Aged 18 to 75 years old (inclusive of both upper and lower limits), male and female subjects are eligible.
ā. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-1.
ā. Expected survival ā„ 12 weeks.
ā. Histologically or cytologically confirmed locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) non-squamous 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 \[AJCC\]), which is inoperable for radical resection and ineligible for radical concurrent/sequential chemoradiotherapy as well as immunotherapy as consolidation treatment.
ā. No prior systemic antineoplastic treatment for the study disease (including systemic chemotherapy, targeted therapy, and immunotherapy).
ā. Subjects must provide tumor tissue samples (archived or freshly obtained) collected at or after the diagnosis of locally advanced or metastatic tumor for central laboratory testing of PD-L1 expression.
. No sensitive EGFR mutations or ALK gene rearrangements. Prior tissue-based test reports for EGFR and ALK status must be provided. If the test reports do not meet the study requirements or are unavailable, tumor tissue samples must be provided for assessment of EGFR and ALK status (tested by a local laboratory recognized by the study site or the central laboratory) before enrollment.
Exclusion criteria
ā. Histologically confirmed presence of any small cell carcinoma, neuroendocrine carcinoma, or sarcoma components \[mixed-type NSCLC (e.g., adenosquamous carcinoma) is permitted for enrollment\].
ā. 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.
ā. History of a second primary malignancy within 5 years before screening (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).
ā. Symptomatic central nervous system (CNS) metastasis. For subjects with asymptomatic CNS metastasis or those with symptomatically stable CNS metastasis for ā„ 4 weeks prior to randomization, enrollment is permitted only if all the following criteria are met:
ā. Prior receipt of immunotherapy, including immune checkpoint inhibitors (e.g., anti-PD-1/L1/L2, anti-CTLA-4 agents), immune checkpoint agonists (e.g., ICOS, CD40, GITR, OX40, CD137 agents), or cellular immunotherapy, or any treatment targeting the tumor immune mechanism. Additionally, for subjects who previously received PD-(L)1 inhibitors in the neoadjuvant/adjuvant setting or as consolidation therapy after definitive chemoradiotherapy, enrollment may be permitted (with sponsor approval) if the interval between the end of the last treatment and the occurrence of disease progression is more than 12 months.
ā. Prior receipt of systemic anti-angiogenic therapy, including but not limited to bevacizumab and its biosimilars, Endostar, small-molecule TKIs, and ramucirumab.
ā. Prior anti-tumor therapy or concomitant medication (the washout period is calculated from the end date of the last treatment):a) Participation in any clinical trial within 28 days prior to the first dose;b) Receipt of anti-tumor therapy within 4 weeks prior to the first dose or within 5 half-lives of the drug (whichever is longer), including but not limited to chemotherapy, radiotherapy (thoracic radiotherapy with a dose \> 30 Gy within 180 days prior to the first dose; non-thoracic radiotherapy with a dose \> 30 Gy within 4 weeks prior to the first dose; local palliative radiotherapy with a dose ā¤ 30 Gy for non-target lesions within 2 weeks prior to the first dose), targeted therapy, immunotherapy, or endocrine therapy;c) Use of Chinese herbal medicines (including patent Chinese medicines) with anti-tumor indications within 2 weeks prior to the first dose; use of non-specific immunomodulatory therapy (e.g., interleukin, interferon, thymosin, tumor necrosis factor, etc., excluding IL-11 for the treatment of thrombocytopenia) within 2 weeks prior to the first dose;d) Need for systemic administration of corticosteroids at a dose \> 10 mg/day of prednisone or equivalent dose, or other immunomodulators within 2 weeks prior to randomization. \[Short-term administration (ā¤ 7 days) for prophylaxis (e.g., contrast agent allergy) or treatment of non-autoimmune diseases (e.g., delayed hypersensitivity reaction caused by allergen exposure), or local administration (e.g., intraocular, intra-articular, intranasal, or inhaled administration) is permitted for enrollment\];e) Use or current use of anticoagulants such as warfarin, heparin (excluding heparin for catheter locking or deep vein catheterization), dabigatran etexilate, rivaroxaban, etc., or antiplatelet drugs such as aspirin, clopidogrel, dipyridamole, cilostazol, or other known antiplatelet agents within 2 weeks prior to the first dose.
ā. Major surgery or severe trauma within 4 weeks before the first dose of study treatment; inadequate recovery from prior surgery (as judged by the investigator); anticipated need for major surgery during the study; minor local surgery (e.g., needle biopsy, endoscopy, interventional procedure/examination, excluding vascular access establishment) within 7 days before randomization; presence of incompletely healed surgical incisions or wounds.