A Clinical Study to Evaluate the Efficacy and Safety of HLX26 (Anti-LAG-3 Monoclonal Antibody Injection) Combined With Serplulimab and Chemotherapy in Previously Untreated Advanced NSCLC Patients

Phase

Condition

N/A

Treatment

Placebo

Pemetrexed

HLX26

Clinical Study ID

NCT05787613

HLX26HLX10-NSCLC201

Ages 18-75
All Genders

Study Summary

A Phase II Study to Evaluate the Efficacy, Safety and Tolerability of HLX26 (Anti-LAG-3 Monoclonal Antibody Injection) Combined With Serplulimab (Anti-PD-1 Humanized Monoclonal Antibody Injection) and Chemotherapy in Previously Untreated Advanced Non-small Cell Lung Cancer (NSCLC) Patients

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

Stage IV (AJCC 8th Edition) non-small cell lung cancer confirmed by histology orcytology.
No EGFR sensitive mutation or ALK, ROS1 rearrangement.
Have not received systemic treatment for stage IV disease. For patients who havereceived adjuvant or neoadjuvant treatment, if the adjuvant/neoadjuvant treatment hasbeen completed for at least 6 months, they are allowed to be enrolled.
At least one measurable lesion evaluated by the investigator per RECIST v1.1.
Subjects must provide qualified tumor tissue samples for the detection of PD-L1 andLAG-3 expression level.
Have adequate organ function with expected survival period ≥ 12 weeks and ECOG scoreof 0 or 1.

Exclusion

Key Exclusion Criteria:

Subjects with other histopathological types including small cell lung cancer,neuroendocrine cancer or sarcoma.
Have other malignant tumors within 3 years.
Pleural effusion, pericardial effusion or ascites that require clinical intervention.
Myocardial infarction and poorly controlled arrhythmia occurred within six monthsbefore the first administration of the study drug.
III - IV cardiac insufficiency per NYHA standard or left ventricular ejectionfraction<50%.
Patients with active pulmonary tuberculosis.
Patients with previous or current interstitial pneumonia, pneumoconiosis, radiationpneumonitis, drug-related pneumonitis, or severe pulmonary function impairment thatmay interfere with the detection and management of suspected drug-related pulmonarytoxicity.
Patients who have known active autoimmune diseases or suspected auto-immue disease.Patients in stable condition and do not require systemic immunosuppressant therapy areallowed to be enrolled.
Require systemic treatment with corticosteroids (> 10 mg/day prednisone or equivalent)or other immunosuppressive agents within 14 days prior to the first dose of the studyproducts or during the study.
Patients who have received any T-cell costimulatory agents or immune checkpointblockade therapy, including but not limited to cytotoxic T lymphocyte-associatedantigen-4 (CTLA-4) inhibitors, PD-1 inhibitors, PD-L1 inhibitors.
Patients with a history of severe allergy to any monoclonal antibody products.

Study Design

Placebo

July 10, 2023

July 31, 2027

Study Description

This study is a phase II study to evaluate the efficacy, safety and tolerability of HLX26 in combination with Serplulimab and chemotherapy in the treatment of patients with Non-small cell lung cancer.

The trial was divided into period 1 (safety run-in phase) and period 2 (dose expansion phase).

The first phase is an open-label study, patients will receive varying doses (800 mg, 600 mg or lower) of HLX26 combined with a fixed dose (300 mg) of serplulimab and chemotherapy, administered by intravenous infusion every 3 weeks. Observation period of DLT lasts for 3 weeks after the first administration of HLX26. Safety review committee (SRC) will responsible for the safety of combination treatment. After confirmation of the safety, the efficacy of HLX26 combined with Serplulimab and chemotherapy will be evaluated in period 2.

The second phase (dose expansion phase) is a randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of 2 dose levels of HLX26 combined with fixed-dose (300 mg) of serplulimab and chemotherapy in patients with NSCLC. If the tolerability observation of the 600mg dose group is completed in the first phase, the SRC will review the safety data obtained from the study and decide whether to enter into the second phase; if 2 of the 6 subjects in the 600mg dose group in the first phase occur DLT event, we will continue to explore the safe dose of HLX26 and enroll another 3-6 subjects. Once the maximum tolerated dose (MTD) is found, two doses, MTD and MTD-1, will be selected to enter the dose expansion phase. (The SRC will review the safety and tolerability results obtained in the study to determine the MTD, and will select the dose of MTD-1 below the MTD and within the effective dose range). In the second stage, there are 3 groups and 40 people in each group. The interactive network/voice response system (IWRS) is used to randomly assign qualified subjects to the following three groups in a 1:1:1 allocation ratio:

> Group A: HLX26 MTD intravenous infusion + serplulimab 300 mg intravenous infusion, Q3W; chemotherapy

> Group B: HLX26 MTD-1 intravenous infusion + serplulimab 300 mg intravenous infusion, Q3W; chemotherapy

> Group C: placebo + serplulimab 300 mg intravenous infusion, Q3W; chemotherapy

The chemotherapy will be decided by investigator per patients' pathological type. nsqNSCLC patients will receive pemetrexed and carboplatin as chemotherapy and sqNSCLC patients will receive nab-paclitaxel or paclitaxel and carboplatin.

Connect with a study center

The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu
China
Active - Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai 200032
China
Active - Recruiting
Shanghai Chest Hospital
Shanghai, Shanghai
China
Active - Recruiting

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