Combining a new vascular inhibitor with Bragg therapy for advanced lung cancer

A Clinical Study of Recombinant Human Vascular Endothelial Inhibitor (Endo) in Combination With Bragg Treatment for Advanced Refractory Non-small Cell Lung Cancer

This study is testing a new treatment that combines a vascular inhibitor with Bragg therapy to see if it can help people with advanced lung cancer feel better and live longer.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Second Affiliated Hospital of Soochow University (Academic / other)
• Drugs / interventions: Immunotherapy
• Locations: 1 site (Suzhou)
• Trial ID: NCT06047860 on ClinicalTrials.gov

What this trial studies

This clinical study investigates the efficacy and safety of a recombinant human vascular endothelial inhibitor (Endo) in combination with Bragg therapy for patients with advanced refractory non-small cell lung cancer. The treatment regimen includes radiotherapy, granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and PD-1/PD-L1 inhibitors, starting on the first day of treatment. Patients will receive Endo every 21 days for at least two cycles, followed by maintenance therapy until disease progression or intolerable side effects occur. The study aims to assess the potential benefits of this combination therapy in a challenging patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with recurrent or metastatic advanced non-small cell lung cancer who cannot tolerate standard treatment regimens.

Not a fit: Patients with severe cardiac, pulmonary, hepatic, or renal abnormalities, or those with immunodeficiency may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced refractory non-small cell lung cancer who have limited treatment alternatives.

How similar studies have performed: While the combination of therapies is innovative, similar approaches in targeting advanced lung cancer have shown promise in other studies, suggesting potential for success.

Eligibility criteria

Inclusion Criteria:

1. Patients aged 18-75 years;
2. Patients enrolled must be eligible for patients with recurrent or metastatic advanced non-small cell lung cancer, with a clear pathological diagnosis report or history of disease, with guidelines that do not clearly recommend standard treatment regimens or who are unable to tolerate standard treatment regimens, and with clear measurable metastatic lesions (\>1cm);
3. No congestive heart failure, unstable angina, or unstable arrhythmia within the last 6 months.
4. Patient activity status score of 0-3 on the Eastern Cooperative Oncology Group (ECOG) scale with life expectancy assessed at ≥3 months.
5. No previous severe haematopoietic, cardiac, pulmonary, hepatic or renal abnormalities and immunodeficiency.
6. Absolute T-lymphocyte values ≥ 0.5 times the lower limit of normal and neutrophils ≥ 1.0 x 109/L; AST and ALT ≤ 3.0 times the upper limit of normal (≤ 5.0 times the upper limit of normal for hepatocellular carcinoma/metastatic liver cancer); creatinine ≤ 3.0 times the upper limit of normal, 1 week prior to enrollment.
7. Patients must have the ability to understand and voluntarily sign the informed consent form.

Exclusion Criteria:

1. Pregnant or breastfeeding women;
2. Persons with a history of other malignant disease in the last 5 years, except cured skin cancer and carcinoma in situ of the cervix;
3. Persons with a history of uncontrolled epilepsy, central nervous system disorders or psychiatric disorders whose clinical severity, as judged by the investigator, may prevent the signing of an informed consent or affect the patient's compliance with drug therapy;
4. Clinically significant (i.e., active) cardiac disease such as symptomatic coronary artery disease, New York Heart Association (NYHA) class II or worse congestive heart failure or severe arrhythmias requiring pharmacological intervention, or a history of myocardial infarction within the last 12 months;
5. Persons requiring immunosuppressive therapy for organ transplantation;
6. Known major active infection or, in the judgement of the investigator, major haematological, renal, metabolic, gastrointestinal, endocrine dysfunction or metabolic disorders, or other serious uncontrolled concomitant disease;
7. Hypersensitivity to any investigational drug component;
8. Persons with a history of immunodeficiency, including those who have tested positive for HIV or have other acquired or congenital immunodeficiency diseases, or a history of organ transplantation, or other immune-related diseases requiring long-term oral hormone therapy
9. Persons with active tuberculosis infection;
10. Those with interstitial lung disease or non-infectious pneumonia that may prevent the assessment of pulmonary toxicity associated with the study or the manager;
11. Other conditions that, in the opinion of the investigator, are not suitable for enrolment.

Where this trial is running

Suzhou

• The Second Affiliated Hospital of SchoowUniversity — Suzhou, China (Recruiting)

Study contacts

• Study coordinator: Liyuan Zhang

Conditions Advanced Solid Tumor; Refractory Tumor