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: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥18 years old (calculated on the date of signing the informed consent);

• ECOG PS: 0-1;

• Expected survival ≥3 months;

• histopathologically confirmed non-small cell lung cancer with at least one measurable lesion (according to RECIST 1.1);

• Patients who provided detectable specimens (tissue or cancerous pleural fluid) for genotype testing before enrollment, and whose EGFR and ALK gene test results were negative; Or patients with negative test results; Or patients with positive test results and who are resistant or intolerant after receiving relevant targeted drug therapy.

• Have not been treated with a systematic regimen;

• Patients voluntarily join the project and sign informed consent;

• The function of vital organs is normal

• Physicians can benefit from anrotinib hydrochloride combined immunotherapy based on current clinical practice assessment;

• Patients voluntarily join the project and sign informed consent;

• Require initiation of antirotinib hydrochloride combined immunotherapy within 28 days of informed consent;

Locations
Other Locations
China
Zhe Cheng
RECRUITING
Zhengzhou
Contact Information
Primary
Zhe Cheng
cz711010@163.com
18638027777
Time Frame
Start Date: 2024-01-31
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 33
Treatments
Experimental: Treatment group
Anlotinib combined with penpulimab
Sponsors
Leads: The First Affiliated Hospital of Zhengzhou University

This content was sourced from clinicaltrials.gov