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)

NCT ID: NCT05603013

Last Updated: 2022-11-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-30
• Study Completion Date: 2024-10-17

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

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

Group Type: EXPERIMENTAL

Vinorelbine

Intervention Type: DRUG

Vinorelbine Tartrate Oral

Radiotherapy

Intervention Type: RADIATION

hypofractionated radiotherapy

PD-1/PD-L1 inhibitor

Intervention Type: DRUG

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

GM-CSF

Intervention Type: DRUG

GM-CSF subcutaneous injection

IL-2

Intervention Type: DRUG

IL-2 subcutaneous injection

Interventions

Vinorelbine

Vinorelbine Tartrate Oral

Intervention Type: DRUG

Radiotherapy

hypofractionated radiotherapy

Intervention Type: RADIATION

PD-1/PD-L1 inhibitor

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

Intervention Type: DRUG

GM-CSF

GM-CSF subcutaneous injection

Intervention Type: DRUG

IL-2

IL-2 subcutaneous injection

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Aged 18 years and above;

2. 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;

3. ECOG(Eastern Cooperative Oncology Group) performance is 0-3;

4. Life expectancy greater than 3 months;

5. 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#

6. Signed informed consent form# -

Exclusion Criteria

1. 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.

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital of Soochow University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Second Affiliated Hospital of Soochow University

Suzhou, , China

Countries

China

Central Contacts

Liyuan Zhang

Role: CONTACT

zhangliyuan126@126.com

0512-67784829

Other Identifiers

JD-LK-2022-136-01

Identifier Type: -

Identifier Source: org_study_id