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

NCT06047860 | Unknown Phase 2

• 1 other identifier: JD-LK-2022-173-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Advanced Solid Tumor; Refractory Tumor

Outcome Measures

Primary Outcomes (5)

• 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

• Disease control rate (DCR)

  the percentage of patients who have achieved complete response (CR), partial response (PR) and stable disease (SD)

  six weeks

• Progression free survival (PFS)

  The time from commencement of treatment to disease progression or death from any cause.

  six weeks

• Overall survival (OS)

  The time from the first day of enrollment to death from any cause.

  six weeks

• Incidence of adverse events

  the rate of AE

  six weeks

Study Arms (1)

Intervention group

EXPERIMENTAL

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.

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

Interventions

Radiotherapy RADIATION

hypofractionated radiotherapy/SBRT

Also known as: SBRT

Intervention group

PD-1/PD-L1 inhibitor DRUG

PD-1/PD-L1 inhibitor within one week of radiotherapy

Also known as: PD-1/PD-L1 antibody

Intervention group

Granulocyte-macrophage colony-stimulating factor subcutaneous injection DRUG

IL-2 2 million IU the day after the end of GM-CSF, administered subcutaneously daily for 7 days;

Also known as: GM-CSF

Intervention group

Interleukin 2 subcutaneous injection DRUG

IL-2 2 million IU the day after the end of GM-CSF, administered subcutaneously daily for 7 days;

Also known as: IL-2

Intervention group

Endostatin DRUG

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.

Also known as: Endo

Intervention group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18-75 years;
• 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);
• No congestive heart failure, unstable angina, or unstable arrhythmia within the last 6 months.
• Patient activity status score of 0-3 on the Eastern Cooperative Oncology Group (ECOG) scale with life expectancy assessed at ≥3 months.
• No previous severe haematopoietic, cardiac, pulmonary, hepatic or renal abnormalities and immunodeficiency.
• 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.
• Patients must have the ability to understand and voluntarily sign the informed consent form.

You may not qualify if:

• Pregnant or breastfeeding women;
• Persons with a history of other malignant disease in the last 5 years, except cured skin cancer and carcinoma in situ of the cervix;
• 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;
• 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;
• Persons requiring immunosuppressive therapy for organ transplantation;
• 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;
• Hypersensitivity to any investigational drug component;
• 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
• Persons with active tuberculosis infection;
• Those with interstitial lung disease or non-infectious pneumonia that may prevent the assessment of pulmonary toxicity associated with the study or the manager;
• Other conditions that, in the opinion of the investigator, are not suitable for enrolment.

Sponsors & Collaborators

• Second Affiliated Hospital of Soochow University: lead

Study Sites (1)

The Second Affiliated Hospital of SchoowUniversity

Suzhou, 215004, China

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Radiotherapy; Immune Checkpoint Inhibitors; Granulocyte-Macrophage Colony-Stimulating Factor; Interleukin-2; Endostatins

Intervention Hierarchy (Ancestors)

Therapeutics; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Interleukins; Lymphokines; Angiostatic Proteins; Angiogenic Proteins; Collagen Type XVIII; Non-Fibrillar Collagens; Collagen; Extracellular Matrix Proteins; Scleroproteins

Central Study Contacts

Liyuan Zhang

CONTACT

0512-67784829; zhangliyuan126@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2023
• First Posted: September 21, 2023
• Study Start: June 16, 2023
• Primary Completion: December 30, 2024
• Study Completion: December 31, 2024
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)