Non-small Cell Lung Cancer(NSCLC)Phase 2NCT07738367
Bronchial Artery Chemoembolization (BACE) Combination Therapy for Advanced NSCLC
A Phase 2 study testing Bronchial Arterial Chemoembolization (BACE) and Systemic anti-tumor combination medications in people with Non-small Cell Lung Cancer(NSCLC), run by Fujian Cancer Hospital at 1 site in China.
Trial summary
Patients with advanced non-small cell lung cancer (NSCLC) who experience disease progression after standard systemic therapies or are unable to tolerate such therapies have limited subsequent treatment options. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-small Cell Lung Cancer(NSCLC)
- What is being tested?
- Bronchial Arterial Chemoembolization (BACE) and Systemic anti-tumor combination medications
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 9 Apr 2026to 30 Oct 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 75 years old; Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-2.
- Histopathologically confirmed advanced non-small cell lung cancer (NSCLC), with at least one measurable target lesion defined by RECIST Version 1.1.
- Two eligible patient subgroups:
- Patients with negative driver gene alterations: experienced disease progression or intolerable toxicity after platinum-based doublet chemotherapy combined with PD-1/PD-L1 immune checkpoint inhibitors; Patients with positive driver gene mutations (e.g., EGFR, ALK): experienced disease progression or unacceptable adverse reactions after corresponding targeted therapy plus at least one line of systemic chemotherapy.
- Target lung lesions are suitable for bronchial arterial chemoembolization (BACE), as assessed by interventional radiology specialists.
- Adequate function of major vital organs.
- Able to provide written informed consent prior to any study-related procedures.
Who cannot join
- Histopathological confirmation of mixed small cell lung cancer components.
- Active bleeding or coagulation disorders.
- Severe hypersensitivity to contrast media, chemotherapeutic agents, or combined study medications.
- Extensive and rapidly progressive intra-pulmonary or extra-pulmonary metastatic lesions.
- Angiography during the procedure shows that superselective catheterization cannot completely avoid hazardous blood vessels such as spinal arteries.
- Severe pre-existing hepatic, renal, cardiac, or pulmonary dysfunction.
- Estimated survival time less than 3 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Single-Arm Phase II Study of Bronchial Artery Chemoembolization (BACE) Combination Therapy in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Without Standard Treatment Options
Patients with advanced non-small cell lung cancer (NSCLC) who experience disease progression after standard systemic therapies or are unable to tolerate such therapies have limited subsequent treatment options. Bronchial arterial chemoembolization (BACE) is a locoregional interventional procedure that delivers chemotherapeutic agents directly into tumor-feeding bronchial arteries, followed by arterial embolization, with the aim of increasing local drug exposure and reducing tumor blood supply.
This prospective, open-label, single-arm Phase II study will evaluate the efficacy and safety of BACE-based combination therapy in adult patients with advanced NSCLC who have no remaining standard treatment options and whose target intrathoracic lesions are considered suitable for BACE. Approximately 20 eligible participants are planned for enrollment between April 2026 and April 2028.
Read more
All enrolled participants will receive protocol-specified BACE in combination with systemic anti-tumor therapy. Treatment selection and administration will be performed according to the study protocol, taking into account the participant's molecular characteristics, prior treatments, clinical condition, and treatment tolerance.
The study will primarily assess local tumor control and the safety of the combined treatment strategy. Tumor response and disease progression will be evaluated by contrast-enhanced imaging according to RECIST criteria, and adverse events will be assessed using CTCAE Version 5.0. Additional assessments will include objective tumor response, disease control, progression-free survival, and overall survival.
Exploratory analyses will investigate the systemic pharmacokinetics of chemotherapeutic agents administered during BACE and potential treatment-related changes in the tumor immune microenvironment.
Read the detailed description
This prospective, open-label, single-arm Phase II study is designed to investigate BACE-based combination therapy in patients with advanced non-small cell lung cancer who have exhausted, progressed after, or are unable to tolerate available standard systemic treatments. The study focuses on patients with clinically relevant intrathoracic tumor lesions that remain technically suitable for bronchial arterial intervention.
BACE is intended to provide concentrated locoregional treatment to lung tumors through the bronchial arterial circulation. During the procedure, tumor-feeding bronchial arteries will be identified by angiography and selectively catheterized in accordance with the protocol. Protocol-specified chemotherapeutic agents will then be administered through the target arteries, followed by embolization of the tumor-feeding vessels. This approach is intended to increase drug exposure within the tumor while reducing arterial blood supply and inducing tumor ischemia and necrosis.
BACE will be administered in combination with protocol-defined systemic anti-tumor treatment. The systemic treatment include chemotherapy, immune checkpoint inhibition, targeted therapy, or another protocol-permitted regimen, as appropriate for the participant's tumor molecular profile, previous treatment history, organ function, clinical condition, and prior treatment tolerance. The timing and administration of systemic therapy in relation to BACE will follow the study protocol. There is no control group or placebo treatment in this study.
Before treatment, participants will undergo protocol-specified baseline clinical, laboratory, and imaging assessments. Contrast-enhanced chest computed tomography will be used to document measurable intrathoracic lesions and establish the baseline tumor burden. Follow-up imaging will be performed at protocol-defined intervals to evaluate changes in target lung lesions and overall disease status according to RECIST criteria. Local progression of the treated intrathoracic lesions will be distinguished from progression occurring at other pulmonary or extrapulmonary sites.
Safety monitoring will cover both procedure-related complications and toxicities associated with the combined systemic treatment. Clinical symptoms, laboratory abnormalities, imaging findings, and adverse events will be evaluated throughout treatment and during the protocol-defined safety follow-up period. Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0. Investigators will assess the relationship of each adverse event to BACE, embolization, intra-arterial chemotherapy, and concomitant systemic anti-tumor therapy.
Participants will be followed for local tumor status, overall disease progression, subsequent anti-tumor treatments, and survival. The study is intended to determine whether BACE-based combination therapy can provide clinically meaningful local tumor control with an acceptable safety profile in this heavily pretreated population.
The study also includes exploratory pharmacokinetic and translational research. Peripheral venous blood samples will be collected at protocol-defined time points within 72 hours after BACE to characterize the systemic exposure to chemotherapeutic agents administered through the bronchial arteries. Serial biospecimens collected at baseline, before BACE, and during follow-up will be used to investigate treatment-related changes in local and systemic immune status. These analyses will explore whether ischemia, tumor necrosis, and locoregional drug delivery induced by BACE are associated with changes in the tumor immune microenvironment and whether potential immune biomarkers correlate with treatment response or prognosis.
Time-to-event variables will be summarized using Kaplan-Meier methods. Tumor response proportions will be reported with exact two-sided confidence intervals, and safety findings will be summarized descriptively. Pharmacokinetic and biomarker analyses are exploratory and will primarily use descriptive methods without formal confirmatory hypothesis testing.
- Conditions
- Non-small Cell Lung Cancer(NSCLC)
- Being tested
- Bronchial Arterial Chemoembolization (BACE), Systemic anti-tumor combination medications
- Keywords
- Non-Small Cell Lung Cancer(NSCLC), Bronchial Arterial Chemoembolization(BACE), Interventional Radiology
- 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.
Bronchial Arterial Chemoembolization (BACE)Procedure or surgery
Interventional chemoembolization procedure targeting tumor-feeding bronchial arteries for local tumor control.
Systemic anti-tumor combination medicationsDrug
Systemic chemotherapy, immune checkpoint inhibitors or targeted agents administered in combination with BACE procedure per protocol，the BACE regimen was planned for 2 cycles
| Study group | Role | What they receive |
|---|---|---|
| Bronchial Arterial Chemoembolization (BACE) Combined Anti-Tumor Therapy Arm | Experimental | This is an open-label, prospective single-arm Phase II clinical trial. It aims to evaluate the efficacy and safety of bronchial arterial chemoembolization (BACE) combination therapy in adult patients with advanced non-small cell lung cancer (NSCLC) who have no standard treatment options left. Receives: Procedure: Bronchial Arterial Chemoembolization (BACE); Drug: Systemic anti-tumor combination medications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local Time to Progression (Local TTP) of target intrathoracic lesions
The time from the date of BACE treatment to the first documentation of local progression of target lung lesions, assessed by contrast-enhanced chest CT scan per RECIST criteria.
Measured: Up to 24 months after the first BACE treatment
Incidence and severity of treatment-related adverse events (TRAEs)
All adverse events occurring during the study period, graded per CTCAE v5.0, including laboratory abnormalities and procedural complications related to BACE and combined systemic anti-tumor therapy.
Measured: From the first BACE procedure until 30 days after the last study treatment
Secondary outcomes (4)
Objective Response Rate (ORR)
The proportion of participants achieving complete response (CR) or partial response (PR) of target intrathoracic lesions, evaluated via contrast-enhanced chest CT according to RECIST criteria.
Measured: Up to 24 months after initial BACE treatment
Disease Control Rate (DCR)
The proportion of participants with complete response (CR), partial response (PR), or stable disease (SD) of target intrathoracic lesions assessed by chest CT based on RECIST criteria.
Measured: Up to 24 months after initial BACE treatment
Progression-Free Survival (PFS)
Time from enrollment to the first documentation of any tumor progression (intrapulmonary or extrapulmonary) or death from any cause, whichever occurs first, assessed by RECIST.
Measured: Up to 36 months after enrollment
Overall Survival (OS)
Time from study enrollment to death from any cause. All participants will be followed for survival status regardless of subsequent anti-cancer therapy.
Measured: Up to 36 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start9 Apr 2026
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung Cancer(NSCLC)Studies of the same condition, open and under way.
- 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
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Lin Jinghui, Fujian Cancer Hospital
- Investigators
- Jinghui Lin Jinghui Lin, Bachelor of Medicine(BM), Study chair, Fujian Cancer HospitalShiguang Chen Shiguang Chen, Doctor of Medicine (MD), Study chair, Fujian Cancer HospitalZhuting Fang Zhuting Fang, Doctor of Medicine (MD), Study director, Fujian Cancer HospitalZhiyong He Zhiyong He, Master of Medicine (MM), Study director, Fujian Cancer HospitalQiang Wang Qiang Wang, Bachelor of Medicine(BM), Principal investigator, Fujian Cancer HospitalLihong Weng Lihong Weng, Master of Medicine (MM), Principal investigator, Fujian Cancer HospitalDong Lin Dong Lin, Bachelor of Medicine（BM）, Principal investigator, Fujian Cancer HospitalMeifang Li Meifang Li, Bachelor of Medicine（BM）, Principal investigator, Fujian Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07738367
- Sponsor's protocol ID
- K2026-125
- Status last verified
- Jul 2026
- First submitted
- 12 Jul 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study is a small-sample single-arm Phase II exploratory trial with a total of 20 participants. There is no established plan to share individual participant data (IPD) with external researchers after trial completion. Limited sample size and translational sub-study (PK \& TIME biomarker) data are only for internal research analysis of the study team.
Publications
Cui W, Li J, Tian J, Deng Y, Chen J, Cui J, Wang Q, Mai Q, Chen X, Zhang J, Xu R. Drug-eluting beads bronchial arterial chemoembolization in advanced and standard treatment-refractory/ineligible non-small cell lung cancer. Quant Imaging Med Surg. 2025 Apr 1;15(4):3458-3468. doi: 10.21037/qims-24-1789. Epub 2025 Mar 28.
PubMed 40235787Zhao YW, Liu S, Qin H, Sun JB, Su M, Yu GJ, Zhou J, Gao F, Wang RY, Zhao T, Zhao GS. Efficacy and safety of CalliSpheres drug-eluting beads for bronchial arterial chemoembolization for refractory non-small-cell lung cancer and its impact on quality of life: A multicenter prospective study. Front Oncol. 2023 Apr 14;13:1110917. doi: 10.3389/fonc.2023.1110917. eCollection 2023.
PubMed 37124525Shang B, Li J, Wang X, Li D, Liang B, Wang Y, Han X, Dou W, Chen G, Shang J, Jiang S. Clinical effect of bronchial arterial infusion chemotherapy and CalliSpheres drug-eluting beads in patients with stage II-IV lung cancer: A prospective cohort study. Thorac Cancer. 2020 Aug;11(8):2155-2162. doi: 10.1111/1759-7714.13522. Epub 2020 Jun 30.
PubMed 32603550Zhang F, Liu Y. Clinical study on bronchial artery chemoembolization for unresectable non-small cell lung cancer. Front Oncol. 2025 Sep 3;15:1591752. doi: 10.3389/fonc.2025.1591752. eCollection 2025.
PubMed 40969256Liu Y, Zhang X, Zhang F, Song W. Bronchial artery chemoembolization in the treatment of refractory central lung cancer with atelectasis. Front Oncol. 2024 Jun 12;14:1343324. doi: 10.3389/fonc.2024.1343324. eCollection 2024.
PubMed 38933450Zhang F, Liu Y. Transcatheter arterial chemoembolization for lung malignant tumors. Front Oncol. 2025 Apr 16;15:1551644. doi: 10.3389/fonc.2025.1551644. eCollection 2025.
PubMed 40308513Xiang Y, Liu X, Wang Y, Zheng D, Meng Q, Jiang L, Yang S, Zhang S, Zhang X, Liu Y, Wang B. Mechanisms of resistance to targeted therapy and immunotherapy in non-small cell lung cancer: promising strategies to overcoming challenges. Front Immunol. 2024 Apr 9;15:1366260. doi: 10.3389/fimmu.2024.1366260. eCollection 2024.
PubMed 38655260Koban MU, Hartmann M, Amexis G, Franco P, Huggins L, Shah I, Karachaliou N. Targeted Therapies, Novel Antibodies, and Immunotherapies in Advanced Non-Small Cell Lung Cancer: Clinical Evidence and Drug Approval Patterns. Clin Cancer Res. 2024 Nov 1;30(21):4822-4833. doi: 10.1158/1078-0432.CCR-24-0741.
PubMed 39177967Dong S, Li X, Huang Q, Li Y, Li J, Zhu X, Xue C, Chen R, Zeng Y, Wu J, Zhong Y, Hu S. Resistance to immunotherapy in non-small cell lung cancer: Unraveling causes, developing effective strategies, and exploring potential breakthroughs. Drug Resist Updat. 2025 Jul;81:101215. doi: 10.1016/j.drup.2025.101215. Epub 2025 Feb 25.
PubMed 40081220Gang X, Yan J, Li X, Shi S, Xu L, Liu R, Cai L, Li H, Zhao M. Immune checkpoint inhibitors rechallenge in non-small cell lung cancer: Current evidence and future directions. Cancer Lett. 2024 Nov 1;604:217241. doi: 10.1016/j.canlet.2024.217241. Epub 2024 Sep 10.
PubMed 39260670Su PL, Furuya N, Asrar A, Rolfo C, Li Z, Carbone DP, He K. Recent advances in therapeutic strategies for non-small cell lung cancer. J Hematol Oncol. 2025 Mar 27;18(1):35. doi: 10.1186/s13045-025-01679-1.
PubMed 40140911Planchard D, Popat S, Kerr K, Novello S, Smit EF, Faivre-Finn C, Mok TS, Reck M, Van Schil PE, Hellmann MD, Peters S; ESMO Guidelines Committee. Metastatic non-small cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2018 Oct 1;29(Suppl 4):iv192-iv237. doi: 10.1093/annonc/mdy275. No abstract available.
PubMed 30285222
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm Phase II Study of Bronchial Artery Chemoembolization (BACE) Combination Therapy in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Without Standard Treatment Options
- ClinicalTrials.gov ID
- NCT07738367
- Acronym / sponsor ID
- K2026-125
- Conditions
- Non-small Cell Lung Cancer(NSCLC)
- Keywords
- Non-Small Cell Lung Cancer(NSCLC), Bronchial Arterial Chemoembolization(BACE), Interventional Radiology
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Study start
- 9 Apr 2026 (actual)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Oct 2028 (estimated)
- First posted
- 31 Jul 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.
Patients with advanced non-small cell lung cancer (NSCLC) who experience disease progression after standard systemic therapies or are unable to tolerate such therapies have limited subsequent treatment options. Bronchial arterial chemoembolization (BACE) is a locoregional interventional procedure that delivers chemotherapeutic agents directly into tumor-feeding bronchial arteries, followed by arterial embolization, with the aim of increasing local drug exposure and reducing tumor blood supply.
This prospective, open-label, single-arm Phase II study will evaluate the efficacy and safety of BACE-based combination therapy in adult patients with advanced NSCLC who have no remaining standard treatment options and whose target intrathoracic lesions are considered suitable for BACE. Approximately 20 eligible participants are planned for enrollment between April 2026 and April 2028.
All enrolled participants will receive protocol-specified BACE in combination with systemic anti-tumor therapy. Treatment selection and administration will be performed according to the study protocol, taking into account the participant's molecular characteristics, prior treatments, clinical condition, and treatment tolerance.
The study will primarily assess local tumor control and the safety of the combined treatment strategy. Tumor response and disease progression will be evaluated by contrast-enhanced imaging according to RECIST criteria, and adverse events will be assessed using CTCAE Version 5.0. Additional assessments will include objective tumor response, disease control, progression-free survival, and overall survival.
Exploratory analyses will investigate the systemic pharmacokinetics of chemotherapeutic agents administered during BACE and potential treatment-related changes in the tumor immune microenvironment.
Detailed description
This prospective, open-label, single-arm Phase II study is designed to investigate BACE-based combination therapy in patients with advanced non-small cell lung cancer who have exhausted, progressed after, or are unable to tolerate available standard systemic treatments. The study focuses on patients with clinically relevant intrathoracic tumor lesions that remain technically suitable for bronchial arterial intervention.
BACE is intended to provide concentrated locoregional treatment to lung tumors through the bronchial arterial circulation. During the procedure, tumor-feeding bronchial arteries will be identified by angiography and selectively catheterized in accordance with the protocol. Protocol-specified chemotherapeutic agents will then be administered through the target arteries, followed by embolization of the tumor-feeding vessels. This approach is intended to increase drug exposure within the tumor while reducing arterial blood supply and inducing tumor ischemia and necrosis.
BACE will be administered in combination with protocol-defined systemic anti-tumor treatment. The systemic treatment include chemotherapy, immune checkpoint inhibition, targeted therapy, or another protocol-permitted regimen, as appropriate for the participant's tumor molecular profile, previous treatment history, organ function, clinical condition, and prior treatment tolerance. The timing and administration of systemic therapy in relation to BACE will follow the study protocol. There is no control group or placebo treatment in this study.
Before treatment, participants will undergo protocol-specified baseline clinical, laboratory, and imaging assessments. Contrast-enhanced chest computed tomography will be used to document measurable intrathoracic lesions and establish the baseline tumor burden. Follow-up imaging will be performed at protocol-defined intervals to evaluate changes in target lung lesions and overall disease status according to RECIST criteria. Local progression of the treated intrathoracic lesions will be distinguished from progression occurring at other pulmonary or extrapulmonary sites.
Safety monitoring will cover both procedure-related complications and toxicities associated with the combined systemic treatment. Clinical symptoms, laboratory abnormalities, imaging findings, and adverse events will be evaluated throughout treatment and during the protocol-defined safety follow-up period. Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0. Investigators will assess the relationship of each adverse event to BACE, embolization, intra-arterial chemotherapy, and concomitant systemic anti-tumor therapy.
Participants will be followed for local tumor status, overall disease progression, subsequent anti-tumor treatments, and survival. The study is intended to determine whether BACE-based combination therapy can provide clinically meaningful local tumor control with an acceptable safety profile in this heavily pretreated population.
The study also includes exploratory pharmacokinetic and translational research. Peripheral venous blood samples will be collected at protocol-defined time points within 72 hours after BACE to characterize the systemic exposure to chemotherapeutic agents administered through the bronchial arteries. Serial biospecimens collected at baseline, before BACE, and during follow-up will be used to investigate treatment-related changes in local and systemic immune status. These analyses will explore whether ischemia, tumor necrosis, and locoregional drug delivery induced by BACE are associated with changes in the tumor immune microenvironment and whether potential immune biomarkers correlate with treatment response or prognosis.
Time-to-event variables will be summarized using Kaplan-Meier methods. Tumor response proportions will be reported with exact two-sided confidence intervals, and safety findings will be summarized descriptively. Pharmacokinetic and biomarker analyses are exploratory and will primarily use descriptive methods without formal confirmatory hypothesis testing.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bronchial Arterial Chemoembolization (BACE) Combined Anti-Tumor Therapy Arm | Experimental | Procedure: Bronchial Arterial Chemoembolization (BACE), Drug: Systemic anti-tumor combination medicationsThis is an open-label, prospective single-arm Phase II clinical trial. It aims to evaluate the efficacy and safety of bronchial arterial chemoembolization (BACE) combination therapy in adult patients with advanced non-small cell lung cancer (NSCLC) who have no standard treatment options left. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age between 18 and 75 years old; Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-2.
- Histopathologically confirmed advanced non-small cell lung cancer (NSCLC), with at least one measurable target lesion defined by RECIST Version 1.1.
- Two eligible patient subgroups:
- Patients with negative driver gene alterations: experienced disease progression or intolerable toxicity after platinum-based doublet chemotherapy combined with PD-1/PD-L1 immune checkpoint inhibitors; Patients with positive driver gene mutations (e.g., EGFR, ALK): experienced disease progression or unacceptable adverse reactions after corresponding targeted therapy plus at least one line of systemic chemotherapy.
- Target lung lesions are suitable for bronchial arterial chemoembolization (BACE), as assessed by interventional radiology specialists.
Key exclusion criteria (7 listed)
- Histopathological confirmation of mixed small cell lung cancer components.
- Active bleeding or coagulation disorders.
- Severe hypersensitivity to contrast media, chemotherapeutic agents, or combined study medications.
- Extensive and rapidly progressive intra-pulmonary or extra-pulmonary metastatic lesions.
- Angiography during the procedure shows that superselective catheterization cannot completely avoid hazardous blood vessels such as spinal arteries.
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 |
|---|---|---|
| Bronchial Arterial Chemoembolization (BACE)Interventional chemoembolization procedure targeting tumor-feeding bronchial arteries for local tumor control. | Procedure or surgery | Bronchial Arterial Chemoembolization (BACE) Combined Anti-Tumor Therapy Arm |
| Systemic anti-tumor combination medicationsSystemic chemotherapy, immune checkpoint inhibitors or targeted agents administered in combination with BACE procedure per protocol，the BACE regimen was planned for 2 cycles | Drug | Bronchial Arterial Chemoembolization (BACE) Combined Anti-Tumor Therapy Arm |
Primary outcome
Local Time to Progression (Local TTP) of target intrathoracic lesions
Time frame: Up to 24 months after the first BACE treatment
The time from the date of BACE treatment to the first documentation of local progression of target lung lesions, assessed by contrast-enhanced chest CT scan per RECIST criteria.
Incidence and severity of treatment-related adverse events (TRAEs)
Time frame: From the first BACE procedure until 30 days after the last study treatment
All adverse events occurring during the study period, graded per CTCAE v5.0, including laboratory abnormalities and procedural complications related to BACE and combined systemic anti-tumor therapy.
4 secondary outcomes
Objective Response Rate (ORR)
Time frame: Up to 24 months after initial BACE treatment
Disease Control Rate (DCR)
Time frame: Up to 24 months after initial BACE treatment
Progression-Free Survival (PFS)
Time frame: Up to 36 months after enrollment
Overall Survival (OS)
Time frame: Up to 36 months after enrollment
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 31 Jul 2026.
- Results publication: PubMed 40235787Cui W, Li J, Tian J, Deng Y, Chen J, Cui J, Wang Q, Mai Q, Chen X, Zhang J, Xu R. Drug-eluting beads bronchial arterial chemoembolization in advanced and standard treatment-refractory/ineligible non-small cell lung cancer. Quant Imaging Med Surg. 2025 Apr 1;15(4):3458-3468. doi: 10.21037/qims-24-1789. Epub 2025 Mar 28.
- Results publication: PubMed 37124525Zhao YW, Liu S, Qin H, Sun JB, Su M, Yu GJ, Zhou J, Gao F, Wang RY, Zhao T, Zhao GS. Efficacy and safety of CalliSpheres drug-eluting beads for bronchial arterial chemoembolization for refractory non-small-cell lung cancer and its impact on quality of life: A multicenter prospective study. Front Oncol. 2023 Apr 14;13:1110917. doi: 10.3389/fonc.2023.1110917. eCollection 2023.
- Results publication: PubMed 32603550Shang B, Li J, Wang X, Li D, Liang B, Wang Y, Han X, Dou W, Chen G, Shang J, Jiang S. Clinical effect of bronchial arterial infusion chemotherapy and CalliSpheres drug-eluting beads in patients with stage II-IV lung cancer: A prospective cohort study. Thorac Cancer. 2020 Aug;11(8):2155-2162. doi: 10.1111/1759-7714.13522. Epub 2020 Jun 30.
- Results publication: PubMed 40969256Zhang F, Liu Y. Clinical study on bronchial artery chemoembolization for unresectable non-small cell lung cancer. Front Oncol. 2025 Sep 3;15:1591752. doi: 10.3389/fonc.2025.1591752. eCollection 2025.
- Results publication: PubMed 38933450Liu Y, Zhang X, Zhang F, Song W. Bronchial artery chemoembolization in the treatment of refractory central lung cancer with atelectasis. Front Oncol. 2024 Jun 12;14:1343324. doi: 10.3389/fonc.2024.1343324. eCollection 2024.
- Results publication: PubMed 40308513Zhang F, Liu Y. Transcatheter arterial chemoembolization for lung malignant tumors. Front Oncol. 2025 Apr 16;15:1551644. doi: 10.3389/fonc.2025.1551644. eCollection 2025.
- Results publication: PubMed 38655260Xiang Y, Liu X, Wang Y, Zheng D, Meng Q, Jiang L, Yang S, Zhang S, Zhang X, Liu Y, Wang B. Mechanisms of resistance to targeted therapy and immunotherapy in non-small cell lung cancer: promising strategies to overcoming challenges. Front Immunol. 2024 Apr 9;15:1366260. doi: 10.3389/fimmu.2024.1366260. eCollection 2024.
- Results publication: PubMed 39177967Koban MU, Hartmann M, Amexis G, Franco P, Huggins L, Shah I, Karachaliou N. Targeted Therapies, Novel Antibodies, and Immunotherapies in Advanced Non-Small Cell Lung Cancer: Clinical Evidence and Drug Approval Patterns. Clin Cancer Res. 2024 Nov 1;30(21):4822-4833. doi: 10.1158/1078-0432.CCR-24-0741.
- Results publication: PubMed 40081220Dong S, Li X, Huang Q, Li Y, Li J, Zhu X, Xue C, Chen R, Zeng Y, Wu J, Zhong Y, Hu S. Resistance to immunotherapy in non-small cell lung cancer: Unraveling causes, developing effective strategies, and exploring potential breakthroughs. Drug Resist Updat. 2025 Jul;81:101215. doi: 10.1016/j.drup.2025.101215. Epub 2025 Feb 25.
- Results publication: PubMed 39260670Gang X, Yan J, Li X, Shi S, Xu L, Liu R, Cai L, Li H, Zhao M. Immune checkpoint inhibitors rechallenge in non-small cell lung cancer: Current evidence and future directions. Cancer Lett. 2024 Nov 1;604:217241. doi: 10.1016/j.canlet.2024.217241. Epub 2024 Sep 10.
- Results publication: PubMed 40140911Su PL, Furuya N, Asrar A, Rolfo C, Li Z, Carbone DP, He K. Recent advances in therapeutic strategies for non-small cell lung cancer. J Hematol Oncol. 2025 Mar 27;18(1):35. doi: 10.1186/s13045-025-01679-1.
- Results publication: PubMed 30285222Planchard D, Popat S, Kerr K, Novello S, Smit EF, Faivre-Finn C, Mok TS, Reck M, Van Schil PE, Hellmann MD, Peters S; ESMO Guidelines Committee. Metastatic non-small cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2018 Oct 1;29(Suppl 4):iv192-iv237. doi: 10.1093/annonc/mdy275. No abstract available.
- Individual participant dataSharing planned: No. This study is a small-sample single-arm Phase II exploratory trial with a total of 20 participants. There is no established plan to share individual participant data (IPD) with external researchers after trial completion. Limited sample size and translational sub-study (PK \& TIME biomarker) data are only for internal research analysis of the study team.
Related trials for Non-small Cell Lung Cancer(NSCLC)
RecruitingPhase 1/2
A Study to Investigate ALE.P02 as a Monotherapy or in Combination With Pembrolizumab in Adult Patients With Selected CLDN1+ Solid Tumors
Squamous Non-small-cell Lung Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 3
A Clinical Study to Assess the Efficacy of Adjuvant Immunotherapy With Cemiplimab in Patients With Surgically Removed Non-small Cell Lung Cancer Who Have Not Received Prior Chemotherapy
Non-Small Cell Lung Cancer
RecruitingPhase 2
Testing Osimertinib as a Treatment for Lung Cancers With an EGFR Exon 20 Change
Advanced Lung Non-Small Cell Carcinoma, Recurrent Lung Non-Small Cell Carcinoma
Not yet recruitingPhase 2/3
Master Protocol for the Study of Rilogrotug for the Treatment of Weight Loss and Anorexia in Patients With Cancer Cachexia and mCRC or mNSCLC
Cachexia; Cancer, Cachexia
RecruitingPhase 3
Testing the Impact of an Anti-Cancer Drug, Atezolizumab, After Surgery to Prevent Early Stage Non-small Cell Lung Cancer From Returning, AASI-NSCLC Trial
Lung Non-Small Cell Carcinoma
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.
Jinghui Lin Jinghui Lin, Bachelor of Medicine(BM) study chair
Fujian Cancer Hospital
Shiguang Chen Shiguang Chen, Doctor of Medicine (MD) study chair
Fujian Cancer Hospital
Zhuting Fang Zhuting Fang, Doctor of Medicine (MD) study director
Fujian Cancer Hospital
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 Bronchial Arterial Chemoembolization (BACE) and Systemic anti-tumor combination medications in people with Non-small Cell Lung Cancer(NSCLC), run by Fujian Cancer 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 7 inclusion and 7 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: enrolling by invitation, as of the sponsor's last update on 31 Jul 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local Time to Progression (Local TTP) of target intrathoracic lesions (time frame: Up to 24 months after the first BACE treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07738367, which also lists 12 linked publications.
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 31 Jul 2026.