Back to results

Evaluating the Safety and Efficacy of Pembrolizumab Combined With MWA for Advanced NSCLC

Primary Purpose

Non Small Cell Lung Cancer

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Pembrolizumab

microwave ablation

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring Microwave ablation, Pembrolizumab, NSCLC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Pathologically diagnosed IIIB or IV non-small cell lung cancer.
Previously accepted first-line standard treatment failure or recurrence
At least one measurable lesion.
The patient has not received any other anti-cancer treatment within four weeks.
Any gender, age ≥18 years
ECOG PS : 0-2 points
Expected survival ≥ 6 months
The level of organ function meets the following criteria.

(1) subject to the standard blood test: ANC ≥ 1.5×109 / L, PLT ≥ 50×109 / L, Hb ≥ 90g/L.

(2) biochemical tests must meet the following criteria: TBIL<1.5×ULN, ALT, AST <2.5×ULN ( if liver metastasis ALT, AST can be <5×ULN), BUN, and Cr ≤ 1×ULN).

9. Female patients in child bearing period must have evidence of negative pregnancy test, and agree to take effective contraceptive measures until 6months after therapy.

10. Subjects volunteered to join the study, signed informed consent, good compliance, with follow-up.

Exclusion Criteria:

Patients with two or more kinds of tumors.
Patients with active viral or bacterial infection, and have failed to be controlled by anti-infective treatment.
Patients with seropositive response of Human immunodeficiency virus (HIV) and syphilis, or fail to control the hepatitis B virus or hepatitis C virus infection.
Patients with active rheumatic diseases, organ transplantation and other diseases affecting the immune system seriously.
Patients with severe heart and lung dysfunction.
Patients with severe chronic diseases of kidney, liver and other important organs.
Patients with any other serious illness that the investigators consider it will may affect the patient's treatments, follow-up or assessment, including any uncontrolled clinically significant neurological or psychiatric disorders, immunoregulatory diseases, metabolic diseases, infectious diseases and so on.
Patients who take part in clinical trials of other drugs or biological therapy at present or within 30 days before enrollment.
Patients who need long-term use of immunosuppressive drugs or patients who are undergoing treatment of autoimmune diseases.
Patients who need long-term use of glucocorticoid.
Women patients in gestation period or suckling period.

Sites / Locations

zhang ZhenfengRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Microwave ablation

Pembrolizumab

Arm Description

Firstly, microwave ablation performed at our department by interventional radiologist, then Pembrolizumab will be administered at a dose of 2 mg/kg every three weeks.

Firstly, pembrolizumab was administered intravenously at a dose of 2 mg/kg. Then microwave ablation will be performed if there is no immune-related adverse reactions. Pembrolizumab will also be continuously administered every three weeks until the imaging evaluation of the disease progress.

Outcomes

Primary Outcome Measures

Overall survival

Overall survival (OS) will be defined as the elapsed time from the enrollment to death from any cause. For surviving patients, follow-up will be censored at the date of last contact (or last date known to be alive). Follow-up for OS will occur every 12 weeks (±1 month) until death or withdrawal of consent from the study.

Secondary Outcome Measures

Incidence of Treatment-Emergent Adverse Events（Safety）

All the local reactions, systemic reactions, all the adverse events and serious adverse events obtained during the study of all the patients included in the first stage and the second stage of this study

Progression-Free Survival

From enrollment to progression of disease.

Full Information

NCT ID

NCT03769129

First Posted

November 12, 2018

Last Updated

February 26, 2023

Sponsor

Second Affiliated Hospital of Guangzhou Medical University

1. Study Identification

Unique Protocol Identification Number

NCT03769129

Brief Title

Evaluating the Safety and Efficacy of Pembrolizumab Combined With MWA for Advanced NSCLC

Official Title

A Prospective，Single Center, Randomized Control，Phase III Clinical Study for Evaluating the Safety and Efficacy of Pembrolizumab Combined With MWA for Patients With Stage ⅢB-Ⅳ NSCLC Who Failed With First-line Therapy

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 1, 2018 (Actual)

Primary Completion Date

November 1, 2026 (Anticipated)

Study Completion Date

November 1, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Second Affiliated Hospital of Guangzhou Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This is a prospective, randomized, single clinical study designed to evaluate its safety and efficacy by using Microwave Ablation combine with Pembrolizumab in patients with Stage ⅢB-Ⅳ Non-small Cell Lung.Cancer (NSCLC) who failed with first-line therapy.

Detailed Description

Lung cancer is one of the most common malignant tumors in the world and has become the No. 1 cause of death from malignant tumors in China. Non-small cell lung cancer (NSCLC) includes squamous cell carcinomas, adenocarcinomas, and large cell carcinomas and accounts for about 80-85% of all lung cancers. NSCLC cancer cells divide slowly in a diffusive manner and metastasize at a relatively late stage compared to small cell carcinomas. A majority of patients with NSCLC are already in advanced stages and have a low 5-year survival rate. Treatments for advanced NSCLC include chemotherapy ,targeted therapies and immunotherapy. The microwave ablation is the good choice for patients who cannot tolerate surgical resection. A large number of studies have shown that local minimally invasive ablation therapy within a certain temperature range can stimulate the body to produce an immune response to varying degrees. The study found that for a variety of malignant tumor models, thermal ablation local treatment of in situ tumors, while the disappearance of other metastatic lesions, and treated mice are resistant to secondary vaccination of the same tumor, proving that thermal ablation therapy stimulates long-lasting Anti-tumor immunity. Pembrolizumab are representative drugs for immunosuppressive agents, and its indications have been approved in various types of tumors, including advanced melanoma, advanced squamous non-small cell lung cancer, advanced renal cell carcinoma, and classical Hodgkin's lymphoma and late recurrent head and neck squamous cell carcinoma patients. Whether the combination of the two can cause a stronger anti-tumor immune response in the body. However, the flexibility, safety and efficacy of using Microwave Ablation combine with Pembrolizumab in NSCLC patients are still unclear.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non Small Cell Lung Cancer

Keywords

Microwave ablation, Pembrolizumab, NSCLC

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Microwave ablation

Arm Type

Experimental

Arm Description

Firstly, microwave ablation performed at our department by interventional radiologist, then Pembrolizumab will be administered at a dose of 2 mg/kg every three weeks.

Arm Title

Pembrolizumab

Arm Type

Other

Arm Description

Intervention Type

Drug

Intervention Name(s)

Pembrolizumab

Other Intervention Name(s)

Keytruda

Intervention Description

Pembrolizumab

Intervention Type

Procedure

Intervention Name(s)

microwave ablation

Intervention Description

microwave ablation

Primary Outcome Measure Information:

Title

Overall survival

Description

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Incidence of Treatment-Emergent Adverse Events（Safety）

Description

Time Frame

2 years

Title

Progression-Free Survival

Description

From enrollment to progression of disease.

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Pathologically diagnosed IIIB or IV non-small cell lung cancer. Previously accepted first-line standard treatment failure or recurrence At least one measurable lesion. The patient has not received any other anti-cancer treatment within four weeks. Any gender, age ≥18 years ECOG PS : 0-2 points Expected survival ≥ 6 months The level of organ function meets the following criteria. (1) subject to the standard blood test: ANC ≥ 1.5×109 / L, PLT ≥ 50×109 / L, Hb ≥ 90g/L. (2) biochemical tests must meet the following criteria: TBIL<1.5×ULN, ALT, AST <2.5×ULN ( if liver metastasis ALT, AST can be <5×ULN), BUN, and Cr ≤ 1×ULN). 9. Female patients in child bearing period must have evidence of negative pregnancy test, and agree to take effective contraceptive measures until 6months after therapy. 10. Subjects volunteered to join the study, signed informed consent, good compliance, with follow-up. Exclusion Criteria: Patients with two or more kinds of tumors. Patients with active viral or bacterial infection, and have failed to be controlled by anti-infective treatment. Patients with seropositive response of Human immunodeficiency virus (HIV) and syphilis, or fail to control the hepatitis B virus or hepatitis C virus infection. Patients with active rheumatic diseases, organ transplantation and other diseases affecting the immune system seriously. Patients with severe heart and lung dysfunction. Patients with severe chronic diseases of kidney, liver and other important organs. Patients with any other serious illness that the investigators consider it will may affect the patient's treatments, follow-up or assessment, including any uncontrolled clinically significant neurological or psychiatric disorders, immunoregulatory diseases, metabolic diseases, infectious diseases and so on. Patients who take part in clinical trials of other drugs or biological therapy at present or within 30 days before enrollment. Patients who need long-term use of immunosuppressive drugs or patients who are undergoing treatment of autoimmune diseases. Patients who need long-term use of glucocorticoid. Women patients in gestation period or suckling period.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

zhang zhenfeng, MD,PHD

Phone

02034153532

zhangzhf@gzhmu.edu.cn

First Name & Middle Initial & Last Name or Official Title & Degree

CHEN deji, MD,PHD

Phone

02034153532

chendeji2003@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

zhang zhenfeng, MD,PHD

Organizational Affiliation

Second Affiliated Hospital of Guangzhou Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

zhang Zhenfeng

City

Guangzhou

State/Province

Guangdong

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zhang Zhenfeng

Phone

13202005598

zhangzhf@gzhmu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Don not plan

Learn more about this trial

Evaluating the Safety and Efficacy of Pembrolizumab Combined With MWA for Advanced NSCLC

We'll reach out to this number within 24 hrs