临床试验/NCT07269782

NCT07269782

招募中

2 期

A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Combination With Serplulimab as Neoadjuvant Therapy in Subjects With NSCLC

Shanghai Henlius Biotech1 个研究点分布在 1 个国家目标入组 60 人2026年1月20日

干预措施HLX43 DOSE 1 Serplulimab HLX43 DOSE 2

概览

阶段: 2 期
干预措施: HLX43 DOSE 1
疾病 / 适应症: 未指定
发起方: Shanghai Henlius Biotech
入组人数: 60
试验地点: 1
主要终点: MPR
状态: 招募中
最后更新: 3个月前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

The study is being conducted to to explore the reasonable dosage and evaluate the efficacy and safety of HLX43 (Anti-PD-L1 ADC) in Combination with Serplulimab (Anti-PD-1 Recombinant Humanized Monoclonal Antibody) as Neoadjuvant Therapy in Subjects with Non-Small Cell Lung Cancer (NSCLC)

详细描述

This study is a randomized, open-label phase II clinical study to explore the reasonable dosage and evaluate the efficacy and safety of HLX43 (Anti-PD-L1 ADC) in Combination with Serplulimab (Anti-PD-1 Recombinant Humanized Monoclonal Antibody) as Neoadjuvant Therapy in Subjects with Non-Small Cell Lung Cancer (NSCLC)，In this study, eligible subjects will be randomized at 1:1 ratio, and the patients will be administered with HLX43 at one of the two dose levels plus Serplulimab at a fixed dosage via intravenous infusion every 3 weeks (Q3W) for 4 cycle.

注册库

clinicaltrials.gov

开始日期

2026年1月20日

结束日期

2026年11月30日

最后更新

3个月前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

Shanghai Henlius Biotech

责任方

Sponsor

入排标准

入选标准

•1\. Have a full understanding of the study content, process, and possible adverse reactions before the study, and sign the informed consent form (ICF); voluntarily participate in the study; be able to complete the study as per protocol requirements;
•2\. Aged ≥ 18 years and ≤ 75 years at the time of signing the ICF, male or female;
•3\. Histologically or cytologically confirmed NSCLC;
•4\. Diagnosed with stage II-IIIB NSCLC (according to the Union for International Cancer Control and the American Joint Committee on Cancer (AJCC) TNM staging system for lung cancer (8th edition)), without actionable genomic alterations (AGAs); subjects with non-squamous NSCLC must have previous test results confirming negative EGFR and ALK gene alterations, and if no previous EGFR and ALK test results are available, the subjects are required to undergo relevant tests at the study site; for subjects with squamous NSCLC, if the previous EGFR and/or ALK gene status is unknown, corresponding tests are not required before enrollment in this study;
•5\. Agree to undergo surgery if eligible after neoadjuvant therapy; prior to study enrollment, the subject should be assessed by the primary thoracic surgeon, who holds the main responsibility for the surgery, to confirm eligibility for R0 resection with curative intent as required by the study; the subject must have good cardiac function and be confirmed as eligible for surgical resection with curative intent;
•6\. At least one measurable lesion as per RECIST 1.1 within 4 weeks prior to randomization;
•7\. Subjects who agree to provide archived tumor tissue specimens that meet the testing requirements (either from the most recent surgery or biopsy, preferably within 2 years) or agree to undergo a biopsy to collect tumor tissue for PD-L1 expression testing; Note: Formalin-fixed paraffin-embedded (FFPE) tumor samples (paraffin blocks or unstained sections, which must meet the quality control criteria for testing) from the most recent surgery or biopsy at or after the diagnosis of malignant tumor and pathological reports of such specimens should be provided by subjects.
•8\. The following conditions must be met in terms of the time of the first administration of the investigational product: at least 3 weeks from the previous major surgery or medical device treatment; at least 1 week from the previous minor surgery; recovery of treatment-induced AEs to Grade ≤ 1 (CTCAE v5.0);
•9\. ECOG PS score of 0-1 within one week prior to randomization;
•10\. Life expectancy \> 3 months;

排除标准

•1\. Histologically or cytologically confirmed tumor containing components of small cell lung cancer or neuroendocrine carcinoma;
•2\. Any prior systemic or local anti-tumor therapy for non-small cell lung cancer, including chemotherapy, radiotherapy, or immunotherapy;
•3\. History of any second malignancy within 2 years prior to randomization, except for early-stage malignancies (carcinoma in situ or stage I tumors) that have received radical treatment, such as non-melanoma skin cancer, cervical carcinoma in situ, localized prostate cancer, ductal carcinoma in situ of the breast, and papillary thyroid carcinoma;
•4\. History of adverse events leading to permanent discontinuation of immunotherapy, or history of ≥ Grade 2 immune-related pneumonitis or immune-related myocarditis;
•5\. Subjects with current or prior history of clinically significant pulmonary impairment due to pulmonary comorbidities, including but not limited to any underlying lung disease (e.g., pulmonary embolism within 3 months prior to the first dose, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, interstitial pneumonitis, pneumoconiosis, drug-related pneumonitis, and pleural effusion), any autoimmune, connective tissue, or inflammatory disease that may involve the lungs (i.e., rheumatoid arthritis, Sjogren's syndrome, sarcoidosis), prior pneumonectomy that may interfere with the detection and management of suspected drug-related pulmonary toxicity, or history of radiation pneumonitis within 6 months;
•6\. Patients with any poorly-controlled cardiovascular and cerebrovascular clinical symptoms or diseases, including but not limited to: (1) NYHA Class II or greater heart failure or left ventricular ejection fraction (LVEF) \< 50%; (2) unstable angina pectoris; (3) myocardial infarction or cerebrovascular accident within 6 months (except lacunar infarction, slight cerebral ischemia, or transient ischemic attack); (4) poorly controlled arrhythmia (including QTc interval ≥ 470 ms) (QTc interval is calculated by Fridericia's formula); (5) poorly-controlled hypertension (systolic blood pressure \> 150 mmHg and/or diastolic blood pressure \> 100 mmHg after active treatment);
•7\. Patients with active systemic infectious diseases requiring intravenous antibiotics within 2 weeks prior to randomization;
•8\. Patients who have previously received other antibodies/drugs against immune checkpoints, such as PD-1, PD-L1, CTLA4, etc.;
•9\. Patients who have used moderate or potent CYP2D6 or CYP3A inhibitors or inducers within 2 weeks prior to randomization;
•10\. Patients who have received systemic corticosteroids (prednisone \> 10 mg/d or equivalent dose of similar drug) or other immunosuppressants within 2 weeks prior to randomization; Except: patients treated with topical, ocular, intra-articular, intranasal, and inhaled corticosteroids; short-term prophylactic use of corticosteroids for contrast agents, etc.;

研究组 & 干预措施

HLX43 DOSE 1 + Serplulimab

Patients will receive the treatment once every 3 weeks (Q3W), for 4 cycles.

干预措施: HLX43 DOSE 1

HLX43 DOSE 1 + Serplulimab

Patients will receive the treatment once every 3 weeks (Q3W), for 4 cycles.

干预措施: Serplulimab

HLX43 DOSE 2 + Serplulimab

Patients will receive the treatment once every 3 weeks (Q3W), for 4 cycles.

干预措施: HLX43 DOSE 2

HLX43 DOSE 2 + Serplulimab

Patients will receive the treatment once every 3 weeks (Q3W), for 4 cycles.

干预措施: Serplulimab

结局指标

主要结局

MPR

时间窗: At time of surgery

The percentage of residual viable tumor cells ≤ 10% in the resected primary lesion after neoadjuvant therapy, regardless of the presence of residual viable tumor cells in the lymph nodes.

次要结局

PCR(At time of surgery)
ORR(up to 12 week)
Incidence and severity of adverse events (AEs)(time from the date of the first dose of study drug until the date of death from any cause, assessed up to 24 months)