Microwave ablation plus tislelizumab and docetaxel for advanced NSCLC after first-line immunotherapy progression

Microwave Ablation in Combination With Tislelizumab and Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer After Progression Following First-Line Immunotherapy Plus Chemotherapy: A Prospective, Single-Arm, Phase II Study

This treatment tests whether adding microwave ablation to tislelizumab and docetaxel can help people with advanced non‑small cell lung cancer whose disease progressed after first‑line immunotherapy plus chemotherapy.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Tianjin Medical University Cancer Institute and Hospital (other)
• Drugs / interventions: tislelizumab, chemotherapy, immunotherapy
• Locations: 1 site (Tianjin, Tianjin Municipality)
• Trial ID: NCT07528274 on ClinicalTrials.gov

What this trial studies

This Phase 2 interventional study enrolls adults with stage IIIB–IV NSCLC who have progressed at least six months after starting first‑line tislelizumab plus chemotherapy. Participants receive tislelizumab 200 mg IV every three weeks, docetaxel 75 mg/m² IV every three weeks for 4–6 cycles, and microwave ablation delivered per protocol. The primary outcome is progression‑free survival, and eligible patients must have ECOG 0–2 and adequate organ and bone marrow function. The trial is conducted at Tianjin Cancer Hospital Airport Hospital (Tianjin Medical University Cancer Institute and Hospital) in Tianjin, China.

Who should consider this trial

Good fit: Adults (≥18) with histologically confirmed stage IIIB–IV NSCLC who progressed ≥6 months after initiating first‑line tislelizumab plus chemotherapy, have ECOG 0–2, adequate organ function, and are judged suitable for microwave ablation.

Not a fit: Patients with rapid progression within six months of first‑line treatment, ECOG >2, poor organ function, diffuse disease not amenable to ablation, or differing prior regimens are unlikely to benefit.

Why it matters

Potential benefit: If successful, this combination could extend progression‑free survival and improve local tumor control for patients who have failed first‑line immunotherapy.

How similar studies have performed: Combining local ablation with immunotherapy is an emerging approach with some promising early‑phase reports, while docetaxel is a standard second‑line agent, but this exact combination remains only modestly tested.

Eligibility criteria

Inclusion Criteria:

* Patients with cytologically or histologically confirmed non-small cell lung cancer (NSCLC), classified as stage IIIB, IIIC, or IV (AJCC 9th edition) and not eligible for curative treatment.
* Male or female patients aged ≥18 years who have provided written informed consent.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, with an expected survival of more than 6 months, and deemed suitable for microwave ablation by the investigator.
* Patients must have previously received first-line treatment with tislelizumab in combination with chemotherapy and have documented disease progression based on imaging assessments prior to enrollment. Disease progression must occur ≥6 months after initiation of first-line tislelizumab plus chemotherapy, with or without concomitant anti-angiogenic therapy.
* Adequate organ and bone marrow function, defined as follows:

Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L Platelet count ≥100 × 10⁹/L Hemoglobin ≥90 g/L White blood cell count ≥3.0 × 10⁹/L

Hepatic function:

Total bilirubin \<1.5 × the upper limit of normal (ULN) Aspartate aminotransferase (AST/SGOT), alanine aminotransferase (ALT/SGPT), and alkaline phosphatase (ALP) ≤2.5 × ULN In patients with liver metastases: AST and ALT ≤5.0 × ULN In patients with liver and/or bone metastases: ALP ≤5.0 × ULN

Renal function:

Serum creatinine ≤1.5 × ULN Urine protein \<2+ on urinalysis; if baseline urine protein is ≥2+, a 24-hour urine protein ≤1.0 g is required

Coagulation function:

International normalized ratio (INR) ≤1.5 Activated partial thromboplastin time (aPTT) ≤1.5 × ULN

* Cardiac function defined as left ventricular ejection fraction (LVEF) ≥50%.
* Ability to communicate effectively with the investigator and to comply with study-related visits, treatment, laboratory tests, and other study requirements.

Exclusion Criteria:

Participants meeting any of the following criteria will be excluded from the study:

* Diagnosis of small cell lung cancer (SCLC), including mixed small cell and non-small cell lung cancer.
* Presence of symptomatic brain metastases at the start of treatment.
* Concurrent participation in another interventional clinical trial for cancer treatment.
* History of tracheoesophageal fistula, gastrointestinal perforation, gastrointestinal fistula, or intra-abdominal abscess within 6 months prior to treatment initiation.
* Presence of severe cardiovascular or cerebrovascular disease, including but not limited to:

Cerebrovascular accident (CVA), transient ischemic attack (TIA), myocardial infarction, or significant vascular disease (including but not limited to aortic aneurysm requiring surgical repair or recent arterial thrombosis) within 6 months prior to randomization; Unstable angina; Heart failure classified as New York Heart Association (NYHA) class ≥ II; Mean resting corrected QT interval (QTc) \>470 ms; Any clinically significant resting electrocardiogram (ECG) rhythm, conduction, or morphological abnormalities, such as complete left bundle branch block, third-degree atrioventricular (AV) block, second-degree AV block, or PR interval \>250 ms; Any factors that increase the risk of QTc prolongation or arrhythmic events, including heart failure, electrolyte abnormalities (serum/plasma potassium \< LLN; magnesium \< LLN; calcium \< LLN), congenital long QT syndrome, family history of long QT syndrome, unexplained sudden death of a first-degree relative before the age of 40, or concomitant use of medications known to prolong the QT interval and induce torsades de pointes.

* Major surgical procedures performed within 4 weeks prior to enrollment or planned during the study period.
* Bleeding tendency, high risk of bleeding, or coagulation disorders, including thrombotic events within 6 months prior to randomization and/or history of hemoptysis within 3 months prior to randomization (defined as ≥2.5 mL per episode).
* Presence of unhealed wounds, active gastrointestinal ulcers, or fractures (excluding healed historical fractures).
* Known or suspected hypersensitivity to tislelizumab and/or any of its excipients.
* Pregnant or breastfeeding women.
* Women of childbearing potential or male participants who are unwilling to use effective contraception during the study and for 6 months after the last dose of study treatment.
* Any other condition that, in the opinion of the investigator, would render the participant unsuitable for enrollment in this study.

Where this trial is running

Tianjin, Tianjin Municipality

• Tianjin Cancer Hospital Airport Hospital — Tianjin, Tianjin Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Tongguo Si, MD. Ph.D

Conditions: NSCLC