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)

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 (PRaG 6.0)

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05603013

Enrollment

Registered

2022-11-02

Start date

2022-10-30

Completion date

2024-10-17

Last updated

2022-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Non-Small-Cell Lung, Carcinoma Breast

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.

Interventions

DRUGVinorelbine

Vinorelbine Tartrate Oral

RADIATIONRadiotherapy

hypofractionated radiotherapy

DRUGPD-1/PD-L1 inhibitor

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

DRUGGM-CSF

GM-CSF subcutaneous injection

DRUGIL-2

IL-2 subcutaneous injection

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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. \-

Design outcomes

Primary

Measure	Time frame	Description
Objective Response Rate #ORR#	24 months	Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR).

Secondary

Measure	Time frame	Description
Progression-free Survival (PFS)	24 months	PFS was defined as the time from the first administration of study treatment to the first occurrence of disease progression as determined by investigator using RECIST v1.1 or death from any cause, whichever comes first.
Disease control rate (DCR)	24 months	DCR was defined as the percentage of participants with a complete response (CR), partial response (PR), or stable disease (SD)
Overall survival (OS)	24 months	OS was defined as the time from the first administration of study treatment to death from any cause.
Adverse event	24 months	rate of adverse events

Countries

China

Contacts

Primary ContactLiyuan Zhang

zhangliyuan126@126.com0512-67784829

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026