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

• ClinicalTrials.gov Identifier: NCT06047860
• Recruitment Status: Recruiting
• First Posted: September 21, 2023
• Last Update Posted: September 21, 2023
• Sponsor: Second Affiliated Hospital of Soochow University
• Information provided by (Responsible Party): Second Affiliated Hospital of Soochow University

Tracking Information

• First Submitted Date: September 14, 2023
• First Posted Date: September 21, 2023
• Last Update Posted Date: September 21, 2023
• Actual Study Start Date: June 16, 2023
• Estimated Primary Completion Date: December 30, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 14, 2023)

• overall response rate(ORR) [ Time Frame: six weeks ]
  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.
• Disease control rate (DCR) [ Time Frame: six weeks ]
  the percentage of patients who have achieved complete response (CR), partial response (PR) and stable disease (SD)
• Progression free survival (PFS) [ Time Frame: six weeks ]
  The time from commencement of treatment to disease progression or death from any cause.
• Overall survival (OS) [ Time Frame: six weeks ]
  The time from the first day of enrollment to death from any cause.
• Incidence of adverse events [ Time Frame: six weeks ]
  the rate of AE

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

Detailed 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.

• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Advanced Solid Tumor
• Refractory Tumor

Intervention

• Radiation: Radiotherapy
  hypofractionated radiotherapy/SBRT
  Other Name: SBRT
• Drug: PD-1/PD-L1 inhibitor
  PD-1/PD-L1 inhibitor within one week of radiotherapy
  Other Name: PD-1/PD-L1 antibody
• Drug: 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;
  Other Name: GM-CSF
• Drug: Interleukin 2 subcutaneous injection
  IL-2 2 million IU the day after the end of GM-CSF, administered subcutaneously daily for 7 days;
  Other Name: IL-2
• Drug: 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.
  Other Name: Endo

Study Arms

Experimental: Intervention group

M-CSF 200 μg administered subcutaneously daily for 7 days on the first day of treatment; IL-2 2 million IU administered subcutaneously daily for 7 days the day after GM-CSF; PD-1/PD-L1 inhibitor within one week of radiotherapy; 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.

Interventions:

• Radiation: Radiotherapy
• Drug: PD-1/PD-L1 inhibitor
• Drug: Granulocyte-macrophage colony-stimulating factor subcutaneous injection
• Drug: Interleukin 2 subcutaneous injection
• Drug: Endostatin

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: September 14, 2023): 30
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2024
• Estimated Primary Completion Date: December 30, 2024 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Liyuan Zhang; 0512-67784829; zhangliyuan126@126.com

• Listed Location Countries: China

Administrative Information

• NCT Number: NCT06047860
• Other Study ID Numbers: JD-LK-2022-173-01
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Second Affiliated Hospital of Soochow University
• Original Responsible Party: Same as current
• Current Study Sponsor: Second Affiliated Hospital of Soochow University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Second Affiliated Hospital of Soochow University
• Verification Date: September 2023