NSCLC (Non-small Cell Lung Cancer)Phase 2NCT07528274
Microwave Ablation Plus Tislelizumab and Docetaxel in Advanced NSCLC After First-Line Immunotherapy Failure
A Phase 2 study testing Tislelizumab, Docetaxel and Microwave ablation in people with NSCLC (Non-small Cell Lung Cancer) and NSCLC (Advanced Non-small Cell Lung Cancer), run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC (Non-small Cell Lung Cancer), NSCLC (Advanced Non-small Cell Lung Cancer)
- What is being tested?
- Tislelizumab, Docetaxel and Microwave ablation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2026to 31 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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:
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tianjin Cancer Hospital Airport Hospital
Tianjin, Tianjin Municipality, 300308
Tongguo Si, MD. Ph.D, +86-22-60670123 ext. 5202, drsitg@163.com
About this study
Official title: 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
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:
- Tislelizumab: 200 mg administered intravenously every 3 weeks (Q3W)
- Docetaxel: 75 mg/m² administered intravenously every 3 weeks (Q3W) for 4-6 cycles
- Microwave ablation, administered per protocol
- Being tested
- Tislelizumab, Docetaxel, Microwave ablation
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TislelizumabDrug
Tislelizumab 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.
DocetaxelDrug
Docetaxel 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 ablationOther
Microwave 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.
| Study group | Role | What they receive |
|---|---|---|
| Microwave Ablation Plus Tislelizumab and Docetaxel | Experimental | Participants will receive microwave ablation in combination with tislelizumab and docetaxel following disease progression after first-line immunotherapy plus chemotherapy. Receives: Drug: Tislelizumab; Drug: Docetaxel; Other: Microwave ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 2 years
Secondary outcomes (3)
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.
Measured: up to 2 years
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.
Measured: up to 3 years
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.
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC (Non-small Cell Lung Cancer)Studies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tongguo Si, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07528274
- Sponsor's protocol ID
- EC-2026-0049
- Status last verified
- Apr 2026
- First submitted
- 7 Apr 2026
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07528274
- Acronym / sponsor ID
- EC-2026-0049
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 14 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Tislelizumab: 200 mg administered intravenously every 3 weeks (Q3W)
- Docetaxel: 75 mg/m² administered intravenously every 3 weeks (Q3W) for 4-6 cycles
- Microwave ablation, administered per protocol
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Microwave Ablation Plus Tislelizumab and Docetaxel | Experimental | Drug: Tislelizumab, Drug: Docetaxel, Other: Microwave ablationParticipants will receive microwave ablation in combination with tislelizumab and docetaxel following disease progression after first-line immunotherapy plus chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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:
Key exclusion criteria (14 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TislelizumabTislelizumab 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. | Drug | Microwave Ablation Plus Tislelizumab and Docetaxel |
| DocetaxelDocetaxel 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. | Drug | Microwave Ablation Plus Tislelizumab and Docetaxel |
| Microwave ablationMicrowave 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. | Other | Microwave Ablation Plus Tislelizumab and Docetaxel |
Primary outcome
Progression-free Survival
Time frame: Up to 2 years
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.
3 secondary outcomes
Objective Response Rate
Time frame: up to 2 years
Overall Survival
Time frame: up to 3 years
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tislelizumab, Docetaxel and Microwave ablation in people with NSCLC (Non-small Cell Lung Cancer) and NSCLC (Advanced Non-small Cell Lung Cancer), run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tongguo Si, MD. Ph.D (+86-22-60670123 ext. 5202, drsitg@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.