Combining anlotinib and penpulimab for advanced lung cancer treatment

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

This study is testing if combining two drugs, anlotinib and penpulimab, can help people with advanced lung cancer live longer and feel better.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The First Affiliated Hospital of Zhengzhou University (Academic / other)
• Drugs / interventions: anrotinib, antirotinib, immunotherapy, penpulimab, anlotinib
• Locations: 1 site (Zhengzhou, Henan)
• Trial ID: NCT06341530 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness and safety of anlotinib combined with penpulimab as a front-line treatment for patients with advanced non-small cell lung cancer (NSCLC). It aims to observe how this combination therapy can improve tumor blood vessel normalization and reshape the tumor microenvironment to enhance immune response. The study will measure primary endpoints such as progression-free survival and disease control rate, alongside secondary endpoints including overall survival and quality of life. Patients will be monitored for adverse events and overall treatment outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with histopathologically confirmed advanced NSCLC and specific genetic testing results.

Not a fit: Patients who have previously received systemic treatment for their cancer or those with certain genetic mutations that are not targeted by this therapy may not benefit.

Why it matters

Potential benefit: If successful, this treatment could significantly improve survival rates and quality of life for patients with advanced non-small cell lung cancer.

How similar studies have performed: Previous studies have shown promising results with similar combinations of anti-angiogenic therapies and immunotherapies in treating NSCLC.

Eligibility criteria

Inclusion Criteria:

* 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;

Exclusion Criteria:

* Known allergy or metabolic disorder to any drug in the treatment regimen;
* Those who refuse to take reliable contraceptive methods during pregnancy and lactation or in the appropriate age period;
* Have any history of uncontrolled medical diseases (including uncontrolled diabetes, severe heart, lung, liver and kidney dysfunction, blood, endocrine system diseases, and other malignant tumors);
* Have a history of psychotropic substance abuse, alcoholism or drug use;
* Currently or about to participate in other anti-tumor drug clinical trials;
* Have active, known, or suspected autoimmune diseases (including but not limited to: uveitis, enteritis, hepatitis, pituitaritis, nephritis, vasculitis, hyperthyroidism, hypothyroidism, and asthma requiring bronchodilator treatment, etc.). Patients with hypothyroidism who only need hormone replacement therapy, skin conditions that do not require systemic treatment (such as vitiligo, psoriasis, or alopecia) may be included;
* During the 6 months prior to entering the study, the following conditions occurred: Myocardial infarction, severe/unstable angina pectoris, NYHA grade 2 or higher cardiac dysfunction, poorly controlled arrhythmias (including QTcF interphase \>450 ms in men, \> 470 ms in women, \>450 ms in women, \>450 ms in men, \> 470 ms in women, QTcF interval calculated by Fridericia formula), symptomatic congestive heart failure, cerebrovascular accident (including transient ischemic attack or symptomatic pulmonary embolism);
* Patients receiving hematopoietic stem cells or organ transplants;
* Other factors that may affect patient safety or compliance as determined by the investigator. Such as a serious illness (including mental illness) requiring co-treatment, serious laboratory abnormalities, or other family or social factors. Severe hepatic and renal insufficiency as judged by researchers.

Where this trial is running

Zhengzhou, Henan

• Zhe Cheng — Zhengzhou, Henan, China (Recruiting)

Study contacts

• Study coordinator: Zhe Cheng

Conditions Non-small Cell Lung Cancer