The purpose of this clinical trial is to evaluate progression-free survival (PFS) of microwave ablation in combination with tislelizumab and docetaxel in patients with advanced non-small cell lung cancer (NSCLC) who have progressed following first-line immunotherapy combined with chemotherapy.
Participants with advanced NSCLC who experienced disease progression after first-line immunotherapy plus chemotherapy will receive the following treatments:
1. Tislelizumab: 200 mg administered intravenously every 3 weeks (Q3W) 2. Docetaxel: 75 mg/m² administered intravenously every 3 weeks (Q3W) for 4-6 cycles 3. Microwave ablation, administered per protocol
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.
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.
Single group
Tislelizumab
DrugTislelizumab will be administered at a dose of 200 mg intravenously every 3 weeks (Q3W). Treatment will be continued according to the study protocol until disease progression, unacceptable toxicity, withdrawal of consent, or investigator decision.
Docetaxel
DrugDocetaxel will be administered at a dose of 75 mg/m² intravenously every 3 weeks (Q3W) for a total of 4 to 6 cycles, unless discontinued earlier due to disease progression, unacceptable toxicity, or other protocol-defined criteria.
Microwave ablation
Other interventionMicrowave ablation will be performed concurrently with systemic treatment. The timing and specific procedural details will be determined by the investigator according to clinical practice and patient condition. There is no predefined limit on the number of microwave ablation sessions. In general clinical practice, microwave ablation is delivered at an output power of approximately 40-60 W for a duration of 5-10 minutes per session, with 1 to 3 tumor lesions treated during a single procedure.
Progression-free Survival
PFS was defined as the time from enrollment to the first objectively documented disease progression as assessed by the investigator per RECIST v1.1 or death from any cause, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method.
Objective Response Rate
Objective response rate is defined as the percentage of participants who had a complete response (CR) or partial response (PR) as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 Tumor assessments included computed tomography (CT) scans or magnetic resonance imaging (MRI), with preference for CT, of the chest, abdomen, and pelvis. CR: Disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR: At least a 30% decrease in the size of target lesions and no progression of non-target lesions and no new lesions, or disappearance of all target lesions with persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits and no new lesions.
Overall Survival
OS was defined as the time from enrollment to death from any cause. Median OS was calculated using the Kaplan-Meier method. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive.
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
An adverse event is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study drug, whether considered related to study drug or not. The investigator assessed the severity of each AE and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.03 as defined below: Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate activities of daily living. Grade 3: Severe or medically significant but not immediately life threatening. hospitalization or prolongation of hospitalization indicated; disabling; limiting selfcare activities of daily living. Grade 4: Life threatening consequences; urgent intervention indicated. Grade 5: Death related to AE.
Click on the lead sponsor to view all of their trials.
