A Clinical Study of Recombinant Human Vascular Endothelial Inhibitor in Combination With PRaG for Advanced Refractory Non-small Cell Lung Cancer

Advanced Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06047860
• Other study ID #: JD-LK-2022-173-01
• Status: Recruiting
• Phase: Phase 2
• Start date: June 16, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: September 2023
• Source: Second Affiliated Hospital of Soochow University
• Contact: Liyuan Zhang
• Phone: 0512-67784829
• Email: zhangliyuan126[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Exploring the efficacy and safety of recombinant human vascular endothelial inhibitor (Endo) in combination with Bragg therapy in advanced refractory non-small cell lung

Description:

Radiotherapy: Start radiotherapy on the first day of treatment, as described in 6.2 above; GM-CSF treatment: GM-CSF 200 μg on the first day of treatment, administered subcutaneously daily for 7 days; IL-2 treatment. 2 million IU of IL-2 on the day after GM-CSF, administered subcutaneously daily for 7 days; Immunotherapy: PD-1/PD-L1 inhibitors within one week of radiotherapy; Recombinant human vascular endothelial inhibitor (Endo): Recombinant human vascular endothelial inhibitor (Endo) 210 mg CIV72h starting on the first day of treatment, every 21 days for a minimum of ≥ 2 cycles of this combination therapy. Maintenance treatment phase: Maintenance with PD-1/PD-L1 inhibitor in combination with recombinant human vascular endothelial inhibitor (Endo) until progression or intolerable side effects.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Carcinoma, Non-Small-Cell Lung
• Neoplasms
• Refractory Tumor

Intervention

Radiation:
• Radiotherapy
hypofractionated radiotherapy/SBRT

Drug:
• PD-1/PD-L1 inhibitor
PD-1/PD-L1 inhibitor within one week of radiotherapy
• Granulocyte-macrophage colony-stimulating factor subcutaneous injection
IL-2 2 million IU the day after the end of GM-CSF, administered subcutaneously daily for 7 days;
• Interleukin 2 subcutaneous injection
IL-2 2 million IU the day after the end of GM-CSF, administered subcutaneously daily for 7 days;
• Endostatin
Recombinant human vascular endothelial inhibitor (Endo) 210 mg CIV72h was started on the first day of treatment, every 21 days for a minimum of = 2 cycles of this combination therapy.

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of SchoowUniversity	Suzhou

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Soochow University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall response rate(ORR)	ORR is defined as the proportion of patients who have a partial (PR) or complete response (CR) to therapy among the total number of evaluable patients.	six weeks
Primary	Disease control rate (DCR)	the percentage of patients who have achieved complete response (CR), partial response (PR) and stable disease (SD)	six weeks
Primary	Progression free survival (PFS)	The time from commencement of treatment to disease progression or death from any cause.	six weeks
Primary	Overall survival (OS)	The time from the first day of enrollment to death from any cause.	six weeks
Primary	Incidence of adverse events	the rate of AE	six weeks