NCT06341530

Anlotinib Combined With Penpulimab as Front-line Treatment in Advanced Non-small Cell Lung Cancer

Prospective Clinical Study of Anlotinib Hydrochloride Capsule Combined With Penpulimab Injection in the Front-line Treatment of Advanced Non-small Cell Lung Cancer Patients

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (estimated)
• Sponsor: The First Affiliated Hospital of Zhengzhou University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In recent years, with the emergence and clinical application of anti-angiogenesis therapy, the therapeutic effect of patients has been significantly improved while ensuring that the adverse reactions of patients do not increase. Anti-angiogenic therapy can improve the hypoxia state of tumor tissue, normalize blood vessels, relieve immune suppression in tumor microenvironment, increase the degree of infiltration of immune cells, and fully activate immune cells to achieve the effect of tumor immunity. Previous studies have shown that penpulimab injection combined with anlotinib in the treatment of NSCLC can induce the normalization of tumor blood vessels and reshape the tumor immunosuppressive microenvironment, and the combination of the two can have synergistic effects. This study intends to treat patients with advanced non-small cell lung cancer (NSCLC) confirmed by pathology with the combination of anlotinib and penpulimab injection, and observe the efficacy and safety of anlotinib and penpulimab injection in the first and second lines of NSCLC. This study is expected to provide a reference for the treatment strategy of advanced non-small cell lung cancer patients, and has important clinical value for the treatment of advanced lung cancer.

Detailed description

This study intends to treat patients with advanced non-small cell lung cancer (NSCLC) confirmed by pathology with the combination of anlotinib and penpulimab injection, and observe the efficacy and safety of anlotinib and penpulimab injection in the first and second lines of NSCLC. To describe the therapeutic mode of anlotinib hydrochloride combined with penpulimab injection in the treatment of patients with non-small cell lung cancer (including treatment regimen, dosage, number of treatment cycles, dose adjustment/discontinuation and reasons) and treatment outcomes.Primary endpoints: Progression-free survival (PFS), disease control rate (DCR), objective response rate (ORR). Secondary endpoints: Overall survival (OS), quality of life score (QoL). Safety evaluation indicators: vital signs, laboratory indicators, adverse events (AE), serious adverse events (SAE).

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	anlotinib combined with penpulimab	single arm

Timeline

• Start date: 2024-01-31
• Primary completion: 2024-12-31
• Completion: 2025-12-31
• First posted: 2024-04-02
• Last updated: 2024-04-02

Locations

1 site across 1 country: China