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

NCT03769129 | Recruiting DMC

• 1 other identifier: ZZWMAICI-005
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Non Small Cell Lung Cancer

Keywords

Microwave ablation; Pembrolizumab; NSCLC

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Secondary Outcomes (2)

• Incidence of Treatment-Emergent Adverse Events（Safety）

  2 years

• Progression-Free Survival

  2 years

Study Arms (2)

Microwave ablation

EXPERIMENTAL

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.

Drug: Pembrolizumab; Procedure: microwave ablation

Pembrolizumab

OTHER

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.

Drug: Pembrolizumab; Procedure: microwave ablation

Interventions

Pembrolizumab DRUG

Pembrolizumab

Also known as: Keytruda

Microwave ablation; Pembrolizumab

microwave ablation PROCEDURE

microwave ablation

Microwave ablation; Pembrolizumab

Eligibility Criteria

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

You may qualify if:

• 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).
• \. Female patients in child bearing period must have evidence of negative pregnancy test, and agree to take effective contraceptive measures until 6months after therapy.
• \. Subjects volunteered to join the study, signed informed consent, good compliance, with follow-up.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital of Guangzhou Medical University: lead

Study Sites (1)

zhang Zhenfeng

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• zhang zhenfeng, MD,PHD

  Second Affiliated Hospital of Guangzhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

zhang zhenfeng, MD,PHD

CONTACT

02034153532; zhangzhf@gzhmu.edu.cn

CHEN deji, MD,PHD

CONTACT

02034153532; chendeji2003@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2018
• First Posted: December 7, 2018
• Study Start: November 1, 2018
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2029
• Last Updated: June 25, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)