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)

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05603013
• Other study ID #: JD-LK-2022-136-01
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: October 30, 2022
• Est. completion date: October 17, 2024

Study information

• Verified date: October 2022
• Source: Second Affiliated Hospital of Soochow University
• Contact: Liyuan Zhang
• Phone: 0512-67784829
• Email: zhangliyuan126[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: October 17, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

-

Related Conditions & MeSH terms

• Breast Neoplasms
• Carcinoma
• Carcinoma Breast
• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• Vinorelbine
Vinorelbine Tartrate Oral

Radiation:
• Radiotherapy
hypofractionated radiotherapy

Drug:
• PD-1/PD-L1 inhibitor
PD-1/PD-L1 inhibitor subcutaneous injection or intravenous injection
• GM-CSF
GM-CSF subcutaneous injection
• IL-2
IL-2 subcutaneous injection

Locations

Country	Name	City	State
China	Second Affiliated Hospital of Soochow University	Suzhou

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Soochow University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Progression-free Survival (PFS)	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.	24 months
Secondary	Disease control rate (DCR)	DCR was defined as the percentage of participants with a complete response (CR), partial response (PR), or stable disease (SD)	24 months
Secondary	Overall survival (OS)	OS was defined as the time from the first administration of study treatment to death from any cause.	24 months
Secondary	Adverse event	rate of adverse events	24 months