Vinorelbine Metronomic Chemotherapy Combined With Hypofractionated Radiotherapy, PD-1/PD-L1 Sequential GM-CSF and IL-2 for Treatment of Advanced Refractory Non-small Cell Lung Cancer and Breast Cancer(PRaG 6.0)

NCT05603013 | Unknown Phase 2

• 1 other identifier: JD-LK-2022-136-01
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, single-arm, Phase II investigator-initiated trial of vinorelbine metronomic chemotherapy combined with hypofractionated radiotherapy, PD-1/PD-L1 inhibitor sequential GM-CSF and IL-2 for treatment of advanced refractory non-small cell lung cancer and breast cancer.

Conditions

Carcinoma, Non-Small-Cell Lung; Carcinoma Breast

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate #ORR#

  Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR).

  24 months

Secondary Outcomes (4)

• Progression-free Survival (PFS)

  24 months

• Disease control rate (DCR)

  24 months

• Overall survival (OS)

  24 months

• Adverse event

  24 months

Study Arms (1)

Vinorelbine Combined With Radiotherapy, PD-1/PD-L1 Sequential GM-CSF and IL-2

EXPERIMENTAL

Vinorelbine Metronomic Chemotherapy Combined With Hypofractionated Radiotherapy, PD-1/PD-L1 Sequential GM-CSF and IL-2

Drug: Vinorelbine; Radiation: Radiotherapy; Drug: PD-1/PD-L1 inhibitor; Drug: GM-CSF; Drug: IL-2

Interventions

Vinorelbine DRUG

Vinorelbine Tartrate Oral

Vinorelbine Combined With Radiotherapy, PD-1/PD-L1 Sequential GM-CSF and IL-2

Radiotherapy RADIATION

hypofractionated radiotherapy

Vinorelbine Combined With Radiotherapy, PD-1/PD-L1 Sequential GM-CSF and IL-2

PD-1/PD-L1 inhibitor DRUG

PD-1/PD-L1 inhibitor subcutaneous injection or intravenous injection

Vinorelbine Combined With Radiotherapy, PD-1/PD-L1 Sequential GM-CSF and IL-2

GM-CSF DRUG

GM-CSF subcutaneous injection

Vinorelbine Combined With Radiotherapy, PD-1/PD-L1 Sequential GM-CSF and IL-2

IL-2 DRUG

IL-2 subcutaneous injection

Vinorelbine Combined With Radiotherapy, PD-1/PD-L1 Sequential GM-CSF and IL-2

Eligibility Criteria

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

You may qualify if:

• Aged 18 years and above;
• Diagnosed with histologically or cytologically-confirmed, standard treatment is ineffective (disease progresses after treatment) or locally advanced or metastatic malignant non-small cell lung cancer and breast cancer patients who cannot tolerate standard therapy, cannot receive or do not have standard therapy;
• ECOG(Eastern Cooperative Oncology Group) performance is 0-3;
• Life expectancy greater than 3 months;
• T lymphocyte absolute value ≥0.5 upper limit of normal (ULN), absolute neutrophil count(ANC)≥1.0 x 10(9)/L#serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤3.0\*ULN, or AST and ALT≤5\*ULN with hepatic metastasis; Total serum creatinine ≤1.5\*ULN#
• Signed informed consent form# -

You may not qualify if:

• \. Current pregnancy or lactation# 2. History of other malignant tumors within 5 years prior to dose administration, expect for#malignancies that can be cured after treatment (including but not limited to adequately treated thyroid cancer, cervical carcinoma in situ, basal or squamous cell skin cancer); 3. Uncontrolled epilepsy, central nervous system diseases or mental illness; 4. Currently active clinically significant cardiovascular disease such as uncontrolled arrhythmia, congestive heart failure, or greater than or equal to Class 2 congestive heart failure as defined by the New York Heart Association Functional Classification, or history of myocardial infarction unstable angina, or acute coronary syndrome within 6 months prior to enrollment in the study; 5. Received allogeneic hematopoietic stem cell transplantation or solid organ transplantation; 6. Other serious, uncontrolled concomitant diseases that may affect protocol compliance or interpretation of outcomes, including active opportunistic infections or advanced (severe) infections, uncontrolled diabetes; 7. Allergic to any of the ingredients used in the study; 8. A history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency disease, or a history of organ transplantation, or other immune-related disease requiring long-term oral hormone therapy; 9. Acute and chronic tuberculosis infection; 10. Other disorders with clinical significance according to the researcher's judgment.

Sponsors & Collaborators

• Second Affiliated Hospital of Soochow University: lead

Study Sites (1)

Second Affiliated Hospital of Soochow University

Suzhou, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Breast Neoplasms

Interventions

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

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; 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

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: October 29, 2022
• First Posted: November 2, 2022
• Study Start: October 30, 2022
• Primary Completion: January 1, 2024
• Study Completion: October 17, 2024
• Last Updated: November 2, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)