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

NCT05787613 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: HLX26HLX10-NSCLC201
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 3

Brief 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

Conditions

NSCLC Stage IV

Outcome Measures

Primary Outcomes (3)

• Dose-limiting toxicity (DLT) (Part 1)

  The DLT of HLX26 in combination with Serplulimab and Chemotherapy within 3 weeks after the first administration in previously untreated NSCLC patients

  from day1 to day 21

• Maximum Tolerated Dose (MTD) (Part 1)

  The MTD of HLX26 in combination with Serplulimab and Chemotherapy within 3 weeks after the first administration in previously untreated NSCLC patients

  from day1 to day 21

• Objective Response Rate (ORR) per RECIST 1.1 as Assessed by IRRC ( Part 2)

  The ORR is defined as the percentage of participants who achieve a complete response (CR) or partial response (PR) per RECIST 1.1 as assessed by IRRC.

  approximately up to 12 months

Secondary Outcomes (8)

• Progression Free Survival (PFS) per RECIST 1.1 assessed by IRRC and Investigator

  approximately up to 12 months

• Disease Control Rate (DCR) per RECIST 1.1 as Assessed by IRRC and Investigator

  approximately up to 12 months

• Duration of Response (DOR) per RECIST 1.1 assessed by IRRC and Investigator

  approximately up to 12 months

• Objective Response Rate (ORR) per RECIST 1.1 assessed by Investigator

  approximately up to 12 months

• Overall Survival (OS)

  approximately up to 36 months

Study Arms (3)

HLX26 MTD + serplulimab 300 mg + chemotherapy intravenous infusion Q3W

EXPERIMENTAL

In this group, HLX26 (MTD) in combination with HLX10 (300 mg) and chemotherapy will be intravenously administered every 3 weeks. About 40 subjects will be enrolled in this cohort. Patients will be treated with until disease progression, death, receiving new antitumor treatment, intolerable toxicity or withdrawal of informed consent (whichever occurs first). The efficacy of HLX26 (MTD) in combination with Serplulimab and chemotherapy will be evaluated in this group.

Drug: HLX26; Drug: Serplulimab; Drug: Chemotherapy drug

HLX26 MTD-1 + serplulimab 300 mg + chemotherapy intravenous infusion Q3W

EXPERIMENTAL

In this group, HLX26 (MTD-1) in combination with HLX10 (300 mg) and chemotherapy will be intravenously administered every 3 weeks. About 40 subjects will be enrolled in this cohort. Patients will be treated with until disease progression, death, receiving new antitumor treatment, intolerable toxicity or withdrawal of informed consent (whichever occurs first). The efficacy of HLX26 (MTD-1) in combination with Serplulimab and chemotherapy will be evaluated in this group.

Drug: HLX26; Drug: Serplulimab; Drug: Chemotherapy drug

placebo + serplulimab 300 mg + chemotherapy intravenous infusion Q3W

PLACEBO COMPARATOR

In this group, placebo in combination with HLX10 (300 mg) and chemotherapy will be intravenously administered every 3 weeks. About 40 subjects will be enrolled in this cohort. Patients will be treated with until disease progression, death, receiving new antitumor treatment, intolerable toxicity or withdrawal of informed consent (whichever occurs first). The efficacy of Serplulimab and chemotherapy will be evaluated in this group.

Drug: Serplulimab; Drug: Chemotherapy drug; Drug: Placebo

Interventions

HLX26 DRUG

Anti-LAG-3 monoclonal Antibody Injection

Also known as: Anti-LAG-3 monoclonal Antibody Injection

HLX26 MTD + serplulimab 300 mg + chemotherapy intravenous infusion Q3W; HLX26 MTD-1 + serplulimab 300 mg + chemotherapy intravenous infusion Q3W

Serplulimab DRUG

anti-PD-1 humanized monoclonal antibody injection

Also known as: HLX10

HLX26 MTD + serplulimab 300 mg + chemotherapy intravenous infusion Q3W; HLX26 MTD-1 + serplulimab 300 mg + chemotherapy intravenous infusion Q3W; placebo + serplulimab 300 mg + chemotherapy intravenous infusion Q3W

Chemotherapy drug DRUG

non-squamous NSCLC patients will receive Pemetrexed 500mg/m2, IV, Q3W. Carboplatin AUC 5mg/mL/min, IV, Q3W, up to 4 cycles.squamous NSCLC patients will receive Albumin-paclitaxel 100mg/m2, IV, Q1W or paclitaxel 175mg/m2, IV, Q3W and carboplatin AUC 5 mg/mL/min, IV, Q3W, up to 4 cycles.

HLX26 MTD + serplulimab 300 mg + chemotherapy intravenous infusion Q3W; HLX26 MTD-1 + serplulimab 300 mg + chemotherapy intravenous infusion Q3W; placebo + serplulimab 300 mg + chemotherapy intravenous infusion Q3W

Placebo DRUG

placebo

placebo + serplulimab 300 mg + chemotherapy intravenous infusion Q3W

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stage IV (AJCC 8th Edition) non-small cell lung cancer confirmed by histology or cytology.
• No EGFR sensitive mutation or ALK, ROS1 rearrangement.
• Have not received systemic treatment for stage IV disease. For patients who have received adjuvant or neoadjuvant treatment, if the adjuvant/neoadjuvant treatment has been 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 and LAG-3 expression level.
• Have adequate organ function with expected survival period ≥ 12 weeks and ECOG score of 0 or 1.

You may not qualify if:

• 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 months before the first administration of the study drug.
• III - IV cardiac insufficiency per NYHA standard or left ventricular ejection fraction\<50%.
• Patients with active pulmonary tuberculosis.
• Patients with previous or current interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, or severe pulmonary function impairment that may interfere with the detection and management of suspected drug-related pulmonary toxicity.
• Patients who have known active autoimmune diseases or suspected auto-immue disease. Patients in stable condition and do not require systemic immunosuppressant therapy are allowed 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 study products or during the study.
• Patients who have received any T-cell costimulatory agents or immune checkpoint blockade therapy, including but not limited to cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) inhibitors, PD-1 inhibitors, PD-L1 inhibitors.
• Patients with a history of severe allergy to any monoclonal antibody products.

Sponsors & Collaborators

• Shanghai Henlius Biotech: lead

Study Sites (3)

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2023
• First Posted: March 28, 2023
• Study Start: July 10, 2023
• Primary Completion: February 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: August 6, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)