Combining Pembrolizumab with Microwave Ablation for Advanced Lung Cancer

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

This study is testing if combining an immunotherapy drug called Pembrolizumab with a heat treatment can help people with advanced lung cancer who haven't responded to other treatments feel better and live longer.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Second Affiliated Hospital of Guangzhou Medical University (Academic / other)
• Drugs / interventions: Pembrolizumab, chemotherapy, immunotherapy
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT03769129 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of combining Pembrolizumab, an immunotherapy drug, with microwave ablation in patients with advanced non-small cell lung cancer (NSCLC) who have not responded to first-line treatments. The study aims to stimulate an immune response through local thermal ablation while administering Pembrolizumab to enhance anti-tumor effects. It is a prospective, randomized, single clinical study focusing on patients with stage IIIB-IV NSCLC. The trial will assess the outcomes of this combined approach in improving patient survival and quality of life.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with stage IIIB or IV NSCLC who have failed first-line therapy and have measurable lesions.

Not a fit: Patients with early-stage lung cancer or those who have received other anti-cancer treatments within the last four weeks may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with advanced NSCLC who have limited treatment choices.

How similar studies have performed: Other studies have shown promising results with similar combinations of immunotherapy and local ablation techniques, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

1. Pathologically diagnosed IIIB or IV non-small cell lung cancer.
2. Previously accepted first-line standard treatment failure or recurrence
3. At least one measurable lesion.
4. The patient has not received any other anti-cancer treatment within four weeks.
5. Any gender, age ≥18 years
6. ECOG PS : 0-2 points
7. Expected survival ≥ 6 months
8. 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:

1. Patients with two or more kinds of tumors.
2. Patients with active viral or bacterial infection, and have failed to be controlled by anti-infective treatment.
3. Patients with seropositive response of Human immunodeficiency virus (HIV) and syphilis, or fail to control the hepatitis B virus or hepatitis C virus infection.
4. Patients with active rheumatic diseases, organ transplantation and other diseases affecting the immune system seriously.
5. Patients with severe heart and lung dysfunction.
6. Patients with severe chronic diseases of kidney, liver and other important organs.
7. 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.
8. Patients who take part in clinical trials of other drugs or biological therapy at present or within 30 days before enrollment.
9. Patients who need long-term use of immunosuppressive drugs or patients who are undergoing treatment of autoimmune diseases.
10. Patients who need long-term use of glucocorticoid.
11. Women patients in gestation period or suckling period.

Where this trial is running

Guangzhou, Guangdong

• zhang Zhenfeng — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Principal investigator: zhang zhenfeng, MD,PHD — Second Affiliated Hospital of Guangzhou Medical University
• Study coordinator: zhang zhenfeng, MD,PHD

Conditions Non Small Cell Lung Cancer; Microwave ablation; Pembrolizumab; NSCLC