Clinical trial · Interventional
Evaluating the Safety and Efficacy of Pembrolizumab Combined With MWA for Advanced NSCLC
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
NCT03769129CI-TRIAL-00078238recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| microwave ablation | Procedure | — | UNRESOLVED |
| Pembrolizumab | Drug | Pembrolizumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Microwave ablation
- 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.
- interventionNames
- Drug: Pembrolizumab
- Procedure: microwave ablation
- type
- OTHER
- label
- Pembrolizumab
- description
- 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.
- interventionNames
- Drug: Pembrolizumab
- Procedure: microwave ablation
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDOu Y, Zhang J, Tan H, He B, Li T, Liu M, Zhi C, Huang J, Li M, Zuo S, Shah NUH, Chen Y, Huang J, Chen D, Qin R, Li X, Lian H, Wu Q, Yang H, Zhang Z. CT-guided intratumoral immunotherapy for advanced solid tumors: a prospective clinical study of safety and systemic antitumor effects. Front Immunol. 2026 Jul 24;17:1869154. doi: 10.3389/fimmu.2026.1869154. eCollection 2026. PMID 42568612