Evaluating a new treatment for advanced non-small cell lung cancer

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

This study is testing a new combination treatment for people with advanced non-small cell lung cancer to see if it is safe and effective.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 132 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Shanghai Henlius Biotech (Industry-sponsored)
• Drugs / interventions: radiation, prednisone, Serplulimab, Chemotherapy
• Locations: 3 sites (Xuzhou, Jiangsu and 2 other locations)
• Trial ID: NCT05787613 on ClinicalTrials.gov

What this trial studies

This Phase II clinical trial aims to assess the efficacy, safety, and tolerability of HLX26, an anti-LAG-3 monoclonal antibody, in combination with Serplulimab, an anti-PD-1 antibody, and chemotherapy for patients with previously untreated advanced non-small cell lung cancer (NSCLC). The study is divided into two phases: a safety run-in phase where varying doses of HLX26 will be administered, followed by a randomized, double-blind, placebo-controlled dose expansion phase. Patients will receive treatment every three weeks, and the study will monitor for dose-limiting toxicities and overall treatment efficacy. The trial seeks to identify the maximum tolerated dose and evaluate the combination's effectiveness in this patient population.

Who should consider this trial

Good fit: Ideal candidates include individuals with Stage IV non-small cell lung cancer who have not received prior systemic treatment and meet specific eligibility criteria.

Not a fit: Patients with other types of lung cancer or those who have received recent systemic treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with advanced non-small cell lung cancer.

How similar studies have performed: Other studies have shown promise with similar combination therapies, but this specific approach is being evaluated for the first time.

Eligibility criteria

Key Inclusion Criteria:

1. Stage IV (AJCC 8th Edition) non-small cell lung cancer confirmed by histology or cytology.
2. No EGFR sensitive mutation or ALK, ROS1 rearrangement.
3. 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.
4. At least one measurable lesion evaluated by the investigator per RECIST v1.1.
5. Subjects must provide qualified tumor tissue samples for the detection of PD-L1 and LAG-3 expression level.
6. Have adequate organ function with expected survival period ≥ 12 weeks and ECOG score of 0 or 1.

Key Exclusion Criteria:

1. Subjects with other histopathological types including small cell lung cancer, neuroendocrine cancer or sarcoma.
2. Have other malignant tumors within 3 years.
3. Pleural effusion, pericardial effusion or ascites that require clinical intervention.
4. Myocardial infarction and poorly controlled arrhythmia occurred within six months before the first administration of the study drug.
5. III - IV cardiac insufficiency per NYHA standard or left ventricular ejection fraction\<50%.
6. Patients with active pulmonary tuberculosis.
7. 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.
8. 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.
9. 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.
10. 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.
11. Patients with a history of severe allergy to any monoclonal antibody products.

Where this trial is running

Xuzhou, Jiangsu and 2 other locations

• The Affiliated Hospital of Xuzhou Medical University — Xuzhou, Jiangsu, China (Recruiting)
• Fudan University Shanghai Cancer Center — Shanghai, Shanghai, China (Recruiting)
• Shanghai Chest Hospital — Shanghai, Shanghai, China (Recruiting)

Conditions NSCLC Stage IV