Unresectable Stage III Non-small Cell Lung CancerPhase 2BEACON-LungNCT07561983
Tislelizumab Plus Chemotherapy and BACE for Unresectable NSCLC
A Phase 2 study testing Tislelizumab, Intravenous Chemotherapy and Bronchial Artery Chemoembolization (BACE) in people with Unresectable Stage III Non-small Cell Lung Cancer and Tislelizumab, run by Sichuan Cancer Hospital and Research Institute at 1 site in China.
Trial summary
The goal of this phase 2 trial is to evaluate the efficacy and safety of tislelizumab combined with intravenous chemotherapy and bronchial artery chemoembolization (BACE) as conversion therapy for patients with initially unresectable stage IIIA-IIIB non-small cell lung cancer (NSCLC). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Unresectable Stage III Non-small Cell Lung Cancer, Tislelizumab, Chemotherapy
- What is being tested?
- Tislelizumab, Intravenous Chemotherapy and Bronchial Artery Chemoembolization (BACE)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 80 years
- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
- Newly diagnosed, previously untreated stage IIIA-IIIB NSCLC according to the 9th edition TNM staging system
- Initially unresectable disease as determined by multidisciplinary team (MDT) assessment
- At least 1 measurable intrapulmonary lesion according to RECIST version 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Show all 13Show fewer
- Forced expiratory volume in the first second (FEV1) > 1.0 L and > 40% of predicted normal value
- Estimated life expectancy of at least 3 months
- Adequate organ function
- Willingness to provide tumor tissue for pathology, molecular testing, and PD-L1 assessment before enrollment
- Women of childbearing potential must have a negative pregnancy test within 72 hours before the first dose and agree to use effective contraception during the study and for 3 months after the last dose of tislelizumab
- Men with partners of childbearing potential must agree to use effective contraception during the study and for 3 months after the last dose of tislelizumab
- Ability to understand and willingness to sign a written informed consent form
Who cannot join
- Prior local therapy for NSCLC, including radiotherapy or interventional therapy
- Known positive driver genomic alterations, including EGFR mutations, ALK rearrangements, ROS1 rearrangements, and MET exon 14 skipping alterations
- Distant organ metastasis
- History of another malignancy within the past 5 years
- Active autoimmune disease or history of autoimmune disease requiring systemic treatment
- Known allergy to any study drug or excipient
Show all 13Show fewer
- Interstitial lung disease, non-infectious pneumonitis, chronic obstructive pulmonary disease, or other uncontrolled systemic diseases judged to interfere with study treatment
- Severe chronic or active infection requiring systemic antibacterial, antifungal, or antiviral therapy, including active tuberculosis
- Major surgery requiring general anesthesia within 4 weeks before first dose
- Any medical condition, alcohol or drug abuse, or dependence that may interfere with study treatment, interpretation of results, or increase treatment risk
- Participation in another interventional therapeutic clinical study
- Psychiatric illness or history of psychotropic drug abuse that may compromise study participation
- Any condition judged by the investigator to make the patient unsuitable for the 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
Sichuan Cancer Hospital and Research Institute
Chengdu, Sichuan, 610041
Guohui Xu, +8613708010123, xgh0913@hotmail.com
Xuegang Yang, MD, +8613683476844, yanggangxue@163.com
About this study
Official title: Tislelizumab Combined With Intravenous Chemotherapy and Bronchial Artery Chemoembolization as Conversion Therapy for Unresectable Non-Small Cell Lung Cancer: A Multicenter, Single-Arm, Phase II Trial (BEACON-Lung)
The goal of this phase 2 trial is to evaluate the efficacy and safety of tislelizumab combined with intravenous chemotherapy and bronchial artery chemoembolization (BACE) as conversion therapy for patients with initially unresectable stage IIIA-IIIB non-small cell lung cancer (NSCLC). The main questions it aims to answer are:
- What is the 1-year event-free survival (EFS) rate with this treatment?
- Can this treatment improve tumor response and the chance of curative-intent resection?
- What adverse events occur during treatment?
Participants will receive tislelizumab, intravenous chemotherapy, and BACE for up to 4 cycles. Tumor response and resectability will be evaluated by imaging and multidisciplinary team (MDT) assessment every 2 cycles. Participants who become resectable may undergo surgery followed by postoperative treatment per protocol. Participants who remain unresectable after 4 cycles will receive guideline-recommended chemoradiotherapy followed by tislelizumab consolidation. Regular follow-up will be performed for efficacy and safety assessment.
- Conditions
- Unresectable Stage III Non-small Cell Lung Cancer, Tislelizumab, Chemotherapy, Chemoembolization, Therapeutic, Conversion Therapy
- Being tested
- Tislelizumab, Intravenous Chemotherapy, Bronchial Artery Chemoembolization (BACE)
- Keywords
- Unresectable Non-Small Cell Lung Cancer, Tislelizumab, Chemotherapy, Bronchial Artery Chemoembolization, Conversion Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TislelizumabDrug
Tislelizumab 200 mg is administered intravenously on Day 0 of each 21-day cycle for up to 4 cycles. Postoperative or consolidation tislelizumab may be given according to protocol-defined treatment pathways.
Intravenous ChemotherapyDrug
Intravenous chemotherapy is administered on Day 1 of each 21-day cycle for up to 4 cycles. Patients with lung squamous cell carcinoma receive albumin-bound paclitaxel, and patients with lung adenocarcinoma receive pemetrexed. Carboplatin is administered intra-arterially during BACE in cycles with the procedure; if BACE is not performed in a given cycle, carboplatin is administered intravenously on the same day per protocol.
Bronchial Artery Chemoembolization (BACE)Procedure or surgery
BACE is performed on Day 1 of the first 21-day treatment cycle using intra-arterial carboplatin infusion followed by embolization with 300-500 μm blank microspheres. Subsequent BACE procedures are performed on demand, based on tumor response on contrast-enhanced chest CT and multidisciplinary team (MDT) evaluation. The total number of BACE procedures ranges from 1 to 4.
| Study group | Role | What they receive |
|---|---|---|
| Tislelizumab Plus Chemotherapy and BACE | Experimental | Participants receive tislelizumab, intravenous chemotherapy, and bronchial artery chemoembolization (BACE) as conversion therapy. Tislelizumab 200 mg is administered intravenously on Day 0 of each 21-day cycle. On Day 1, participants receive intravenous chemotherapy (albumin-bound paclitaxel for lung squamous cell carcinoma or pemetrexed for lung adenocarcinoma) and BACE with intra-arterial carboplatin plus 300-500 μm blank microspheres. Conversion treatment is given for up to 4 cycles. The number of BACE procedures ranges from 1 to 4 and is determined by tumor response and multidisciplinary team assessment. Participants who become resectable may undergo surgery followed by protocol-defined postoperative treatment. Participants who remain unresectable after 4 cycles may receive guideline-recommended chemoradiotherapy followed by tislelizumab consolidation. Receives: Drug: Tislelizumab; Drug: Intravenous Chemotherapy; Procedure: Bronchial Artery Chemoembolization (BACE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-Year Event-Free Survival (EFS) Rate
The proportion of participants who remain event-free at 1 year after the first dose of study treatment. Events include radiographic disease progression according to RECIST 1.1, failure to complete the planned surgery for any reason, postoperative recurrence, or death from any cause.
Measured: 1 year after the first dose of study treatment
Secondary outcomes (7)
R0 Resection Rate
The proportion of participants who undergo curative-intent surgery and achieve microscopically margin-negative (R0) resection after conversion treatment.
Measured: Up to approximately 20 weeks after the first dose of study treatment
Objective Response Rate (ORR)
The proportion of evaluable participants who achieve a complete response (CR) or partial response (PR) according to RECIST version 1.1 based on center imaging assessment.
Measured: Up to approximately 30 months after the first dose of study treatment.
Pathologic Complete Response (pCR) Rate
The proportion of participants who undergo surgery and have no residual viable tumor cells in the resected primary tumor and all resected lymph nodes.
Measured: At the time of surgery, up to approximately 20 weeks after the first dose of study treatment.
Major Pathologic Response (MPR) Rate
The proportion of participants who undergo surgery and have 10% or less residual viable tumor cells in the resected primary tumor.
Measured: At the time of surgery, up to approximately 20 weeks after the first dose of study treatment.
Event-Free Survival (EFS)
Time from the first dose of study treatment to the first occurrence of radiographic disease progression according to RECIST 1.1, failure to complete the planned surgery for any reason, postoperative recurrence, or death from any cause. Participants without an event will be censored at the date of last follow-up.
Measured: From the first dose of study treatment up to approximately 30 months
Overall Survival (OS)
Time from the first dose of study treatment to death from any cause. Participants who are lost to follow-up or alive at the end of study follow-up will be censored at the last known date alive.
Measured: From the first dose of study treatment up to approximately 30 months.
Incidence of Adverse Events
Incidence, severity, relationship to study treatment, and outcomes of adverse events assessed according to NCI-CTCAE version 5.0.
Measured: From the first dose of study treatment up to approximately 30 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start1 May 2026 (estimated)
- Primary completion31 Oct 2028 (estimated)
- Study completion31 Dec 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 Unresectable Stage III Non-small Cell Lung CancerStudies 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
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Cancer Hospital and Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guohui Xu, Sichuan Cancer Hospital and Research Institute
- Investigators
- Xuegang Yang, MD, Principal investigator, Sichuan Cancer Hospital and Research InstituteGuohui Xu, MD, Study chair, Sichuan Cancer Hospital and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07561983
- Sponsor's protocol ID
- KY-2025-346-03
- Acronym
- BEACON-Lung
- Status last verified
- Apr 2026
- First submitted
- 24 Apr 2026
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data are not planned to be publicly shared because of privacy, ethical, and legal considerations. The study includes sensitive clinical, imaging, and biomarker data, and the relatively small sample size may increase the risk of participant re-identification. Summary statistical data may be obtained from the Principal Investigator upon reasonable request and with approval from the Ethics Committee.
Publications
Liu B, Zhou J, He W, Zhang R, Cheng X, Xu L, Xie B, Liang Y, Guo S. Bronchial artery infusion of PD-1 inhibitors plus chemotherapy improves progression-free survival in advanced NSCLC: a prospective cohort study. Sci Rep. 2026 Feb 3;16(1):7067. doi: 10.1038/s41598-026-37607-7.
PubMed 41634290Zheng L, Zhang D, Zhang Y, Chen L, Chen W, Huang C, Zhu L, Fang S, Weng Q, Chen M, Tu J, Zhao Z, Ji J. Efficacy and safety of bronchial artery chemoembolization combined with chemotherapy and immune checkpoint inhibitors for advanced lung squamous cell carcinoma. Eur J Med Res. 2026 Feb 12. doi: 10.1186/s40001-026-03979-9. Online ahead of print.
PubMed 41680955Liang C, Han D, Li H, Wang M, Kuang D, Chen H, Miao H, Chen P, Lu H, Jiao P, Ren J, Han X, Li F, Duan X. Bronchial Arterial Chemoembolization Combined with Tislelizumab for Non-Small Cell Lung Cancer: An Exploratory, Prospective, Single-Arm, Phase II Trial. J Vasc Interv Radiol. 2026 Apr;37(4):108001. doi: 10.1016/j.jvir.2026.108001. Epub 2026 Jan 16.
PubMed 41548595Xiang J, Lan W, Cai D, Wang Y, Li W, Tu J, Huang J. Clinical outcomes, toxic effect, and immune microenvironment changes of drug-eluting bead bronchial arterial chemoembolisation/bronchial arterial chemoembolization combined with immunotherapy in treating elderly patients with non-small cell lung cancer. Clin Radiol. 2025 May;84:106849. doi: 10.1016/j.crad.2025.106849. Epub 2025 Feb 13.
PubMed 40068253Sheng J, Luo H, Liu X, Liu C, Zhou W, Zhao Y, Liu R, Li D, Xu C, Yang B, Liu Y, Fu X, Bao L, Wang K, Hao J, Liu W. Tislelizumab (anti-PD-1) plus chemotherapy as neoadjuvant therapy for patients with stage IB3/IIA2 cervical cancer (NATIC): a prospective, single-arm, phase II study. Signal Transduct Target Ther. 2025 Jul 4;10(1):215. doi: 10.1038/s41392-025-02294-9.
PubMed 40615377Zhou Q, Pan Y, Yang X, Zhao Y, Han G, Pang Q, Zhang Z, Wang Q, Yao J, Wang H, Yang W, Liu B, Chen Q, Du X, Cai K, Li B, Huang Y, Li X, Song L, Shi W, Wu YL. Neoadjuvant SHR-1701 with or without chemotherapy in unresectable stage III non-small-cell lung cancer: A proof-of-concept, phase 2 trial. Cancer Cell. 2024 Jul 8;42(7):1258-1267.e2. doi: 10.1016/j.ccell.2024.05.024. Epub 2024 Jun 20.
PubMed 38906157Sorin M, Prosty C, Ghaleb L, Nie K, Katergi K, Shahzad MH, Dube LR, Atallah A, Swaby A, Dankner M, Crump T, Walsh LA, Fiset PO, Sepesi B, Forde PM, Cascone T, Provencio M, Spicer JD. Neoadjuvant Chemoimmunotherapy for NSCLC: A Systematic Review and Meta-Analysis. JAMA Oncol. 2024 May 1;10(5):621-633. doi: 10.1001/jamaoncol.2024.0057.
PubMed 38512301Rami-Porta R, Nishimura KK, Giroux DJ, Detterbeck F, Cardillo G, Edwards JG, Fong KM, Giuliani M, Huang J, Kernstine KH Sr, Marom EM, Nicholson AG, Van Schil PE, Travis WD, Tsao MS, Watanabe SI, Rusch VW, Asamura H; Members of the IASLC Staging and Prognostic Factors Committee and of the Advisory Boards, and Participating Institutions. The International Association for the Study of Lung Cancer Lung Cancer Staging Project: Proposals for Revision of the TNM Stage Groups in the Forthcoming (Ninth) Edition of the TNM Classification for Lung Cancer. J Thorac Oncol. 2024 Jul;19(7):1007-1027. doi: 10.1016/j.jtho.2024.02.011. Epub 2024 Mar 4.
PubMed 38447919Wakelee H, Liberman M, Kato T, Tsuboi M, Lee SH, Gao S, Chen KN, Dooms C, Majem M, Eigendorff E, Martinengo GL, Bylicki O, Rodriguez-Abreu D, Chaft JE, Novello S, Yang J, Keller SM, Samkari A, Spicer JD; KEYNOTE-671 Investigators. Perioperative Pembrolizumab for Early-Stage Non-Small-Cell Lung Cancer. N Engl J Med. 2023 Aug 10;389(6):491-503. doi: 10.1056/NEJMoa2302983. Epub 2023 Jun 3.
PubMed 37272513Heymach JV, Harpole D, Mitsudomi T, Taube JM, Galffy G, Hochmair M, Winder T, Zukov R, Garbaos G, Gao S, Kuroda H, Ostoros G, Tran TV, You J, Lee KY, Antonuzzo L, Papai-Szekely Z, Akamatsu H, Biswas B, Spira A, Crawford J, Le HT, Aperghis M, Doherty GJ, Mann H, Fouad TM, Reck M; AEGEAN Investigators. Perioperative Durvalumab for Resectable Non-Small-Cell Lung Cancer. N Engl J Med. 2023 Nov 2;389(18):1672-1684. doi: 10.1056/NEJMoa2304875. Epub 2023 Oct 23.
PubMed 37870974Forde PM, Spicer J, Lu S, Provencio M, Mitsudomi T, Awad MM, Felip E, Broderick SR, Brahmer JR, Swanson SJ, Kerr K, Wang C, Ciuleanu TE, Saylors GB, Tanaka F, Ito H, Chen KN, Liberman M, Vokes EE, Taube JM, Dorange C, Cai J, Fiore J, Jarkowski A, Balli D, Sausen M, Pandya D, Calvet CY, Girard N; CheckMate 816 Investigators. Neoadjuvant Nivolumab plus Chemotherapy in Resectable Lung Cancer. N Engl J Med. 2022 May 26;386(21):1973-1985. doi: 10.1056/NEJMoa2202170. Epub 2022 Apr 11.
PubMed 35403841Antonia SJ, Villegas A, Daniel D, Vicente D, Murakami S, Hui R, Yokoi T, Chiappori A, Lee KH, de Wit M, Cho BC, Bourhaba M, Quantin X, Tokito T, Mekhail T, Planchard D, Kim YC, Karapetis CS, Hiret S, Ostoros G, Kubota K, Gray JE, Paz-Ares L, de Castro Carpeno J, Wadsworth C, Melillo G, Jiang H, Huang Y, Dennis PA, Ozguroglu M; PACIFIC Investigators. Durvalumab after Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer. N Engl J Med. 2017 Nov 16;377(20):1919-1929. doi: 10.1056/NEJMoa1709937. Epub 2017 Sep 8.
PubMed 28885881
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tislelizumab Combined With Intravenous Chemotherapy and Bronchial Artery Chemoembolization as Conversion Therapy for Unresectable Non-Small Cell Lung Cancer: A Multicenter, Single-Arm, Phase II Trial (BEACON-Lung)
- ClinicalTrials.gov ID
- NCT07561983
- Acronym / sponsor ID
- BEACON-Lung / KY-2025-346-03
- Conditions
- Unresectable Stage III Non-small Cell Lung Cancer, Tislelizumab, Chemotherapy, Chemoembolization, Therapeutic, Conversion Therapy
- Keywords
- Unresectable Non-Small Cell Lung Cancer, Tislelizumab, Chemotherapy, Bronchial Artery Chemoembolization, Conversion Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Sichuan Cancer Hospital and Research InstituteUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 1 May 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 goal of this phase 2 trial is to evaluate the efficacy and safety of tislelizumab combined with intravenous chemotherapy and bronchial artery chemoembolization (BACE) as conversion therapy for patients with initially unresectable stage IIIA-IIIB non-small cell lung cancer (NSCLC). The main questions it aims to answer are:
- What is the 1-year event-free survival (EFS) rate with this treatment?
- Can this treatment improve tumor response and the chance of curative-intent resection?
- What adverse events occur during treatment?
Participants will receive tislelizumab, intravenous chemotherapy, and BACE for up to 4 cycles. Tumor response and resectability will be evaluated by imaging and multidisciplinary team (MDT) assessment every 2 cycles. Participants who become resectable may undergo surgery followed by postoperative treatment per protocol. Participants who remain unresectable after 4 cycles will receive guideline-recommended chemoradiotherapy followed by tislelizumab consolidation. Regular follow-up will be performed for efficacy and safety assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tislelizumab Plus Chemotherapy and BACE | Experimental | Drug: Tislelizumab, Drug: Intravenous Chemotherapy, Procedure: Bronchial Artery Chemoembolization (BACE)Participants receive tislelizumab, intravenous chemotherapy, and bronchial artery chemoembolization (BACE) as conversion therapy. Tislelizumab 200 mg is administered intravenously on Day 0 of each 21-day cycle. On Day 1, participants receive intravenous chemotherapy (albumin-bound paclitaxel for lung squamous cell carcinoma or pemetrexed for lung adenocarcinoma) and BACE with intra-arterial carboplatin plus 300-500 μm blank microspheres. Conversion treatment is given for up to 4 cycles. The number of BACE procedures ranges from 1 to 4 and is determined by tumor response and multidisciplinary team assessment. Participants who become resectable may undergo surgery followed by protocol-defined postoperative treatment. Participants who remain unresectable after 4 cycles may receive guideline-recommended chemoradiotherapy followed by tislelizumab consolidation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age 18 to 80 years
- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
- Newly diagnosed, previously untreated stage IIIA-IIIB NSCLC according to the 9th edition TNM staging system
- Initially unresectable disease as determined by multidisciplinary team (MDT) assessment
- At least 1 measurable intrapulmonary lesion according to RECIST version 1.1
Key exclusion criteria (13 listed)
- Prior local therapy for NSCLC, including radiotherapy or interventional therapy
- Known positive driver genomic alterations, including EGFR mutations, ALK rearrangements, ROS1 rearrangements, and MET exon 14 skipping alterations
- Distant organ metastasis
- History of another malignancy within the past 5 years
- Active autoimmune disease or history of autoimmune disease requiring systemic treatment
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 200 mg is administered intravenously on Day 0 of each 21-day cycle for up to 4 cycles. Postoperative or consolidation tislelizumab may be given according to protocol-defined treatment pathways. | Drug | Tislelizumab Plus Chemotherapy and BACE |
| Intravenous ChemotherapyIntravenous chemotherapy is administered on Day 1 of each 21-day cycle for up to 4 cycles. Patients with lung squamous cell carcinoma receive albumin-bound paclitaxel, and patients with lung adenocarcinoma receive pemetrexed. Carboplatin is administered intra-arterially during BACE in cycles with the procedure; if BACE is not performed in a given cycle, carboplatin is administered intravenously on the same day per protocol. | Drug | Tislelizumab Plus Chemotherapy and BACE |
| Bronchial Artery Chemoembolization (BACE)BACE is performed on Day 1 of the first 21-day treatment cycle using intra-arterial carboplatin infusion followed by embolization with 300-500 μm blank microspheres. Subsequent BACE procedures are performed on demand, based on tumor response on contrast-enhanced chest CT and multidisciplinary team (MDT) evaluation. The total number of BACE procedures ranges from 1 to 4. | Procedure or surgery | Tislelizumab Plus Chemotherapy and BACE |
Primary outcome
1-Year Event-Free Survival (EFS) Rate
Time frame: 1 year after the first dose of study treatment
The proportion of participants who remain event-free at 1 year after the first dose of study treatment. Events include radiographic disease progression according to RECIST 1.1, failure to complete the planned surgery for any reason, postoperative recurrence, or death from any cause.
7 secondary outcomes
R0 Resection Rate
Time frame: Up to approximately 20 weeks after the first dose of study treatment
Objective Response Rate (ORR)
Time frame: Up to approximately 30 months after the first dose of study treatment.
Pathologic Complete Response (pCR) Rate
Time frame: At the time of surgery, up to approximately 20 weeks after the first dose of study treatment.
Major Pathologic Response (MPR) Rate
Time frame: At the time of surgery, up to approximately 20 weeks after the first dose of study treatment.
Event-Free Survival (EFS)
Time frame: From the first dose of study treatment up to approximately 30 months
Overall Survival (OS)
Time frame: From the first dose of study treatment up to approximately 30 months.
Incidence of Adverse Events
Time frame: From the first dose of study treatment up to approximately 30 months.
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 1 May 2026.
- Background: PubMed 41634290Liu B, Zhou J, He W, Zhang R, Cheng X, Xu L, Xie B, Liang Y, Guo S. Bronchial artery infusion of PD-1 inhibitors plus chemotherapy improves progression-free survival in advanced NSCLC: a prospective cohort study. Sci Rep. 2026 Feb 3;16(1):7067. doi: 10.1038/s41598-026-37607-7.
- Background: PubMed 41680955Zheng L, Zhang D, Zhang Y, Chen L, Chen W, Huang C, Zhu L, Fang S, Weng Q, Chen M, Tu J, Zhao Z, Ji J. Efficacy and safety of bronchial artery chemoembolization combined with chemotherapy and immune checkpoint inhibitors for advanced lung squamous cell carcinoma. Eur J Med Res. 2026 Feb 12. doi: 10.1186/s40001-026-03979-9. Online ahead of print.
- Background: PubMed 41548595Liang C, Han D, Li H, Wang M, Kuang D, Chen H, Miao H, Chen P, Lu H, Jiao P, Ren J, Han X, Li F, Duan X. Bronchial Arterial Chemoembolization Combined with Tislelizumab for Non-Small Cell Lung Cancer: An Exploratory, Prospective, Single-Arm, Phase II Trial. J Vasc Interv Radiol. 2026 Apr;37(4):108001. doi: 10.1016/j.jvir.2026.108001. Epub 2026 Jan 16.
- Background: PubMed 40068253Xiang J, Lan W, Cai D, Wang Y, Li W, Tu J, Huang J. Clinical outcomes, toxic effect, and immune microenvironment changes of drug-eluting bead bronchial arterial chemoembolisation/bronchial arterial chemoembolization combined with immunotherapy in treating elderly patients with non-small cell lung cancer. Clin Radiol. 2025 May;84:106849. doi: 10.1016/j.crad.2025.106849. Epub 2025 Feb 13.
- Background: PubMed 40615377Sheng J, Luo H, Liu X, Liu C, Zhou W, Zhao Y, Liu R, Li D, Xu C, Yang B, Liu Y, Fu X, Bao L, Wang K, Hao J, Liu W. Tislelizumab (anti-PD-1) plus chemotherapy as neoadjuvant therapy for patients with stage IB3/IIA2 cervical cancer (NATIC): a prospective, single-arm, phase II study. Signal Transduct Target Ther. 2025 Jul 4;10(1):215. doi: 10.1038/s41392-025-02294-9.
- Background: PubMed 38906157Zhou Q, Pan Y, Yang X, Zhao Y, Han G, Pang Q, Zhang Z, Wang Q, Yao J, Wang H, Yang W, Liu B, Chen Q, Du X, Cai K, Li B, Huang Y, Li X, Song L, Shi W, Wu YL. Neoadjuvant SHR-1701 with or without chemotherapy in unresectable stage III non-small-cell lung cancer: A proof-of-concept, phase 2 trial. Cancer Cell. 2024 Jul 8;42(7):1258-1267.e2. doi: 10.1016/j.ccell.2024.05.024. Epub 2024 Jun 20.
- Background: PubMed 38512301Sorin M, Prosty C, Ghaleb L, Nie K, Katergi K, Shahzad MH, Dube LR, Atallah A, Swaby A, Dankner M, Crump T, Walsh LA, Fiset PO, Sepesi B, Forde PM, Cascone T, Provencio M, Spicer JD. Neoadjuvant Chemoimmunotherapy for NSCLC: A Systematic Review and Meta-Analysis. JAMA Oncol. 2024 May 1;10(5):621-633. doi: 10.1001/jamaoncol.2024.0057.
- Background: PubMed 38447919Rami-Porta R, Nishimura KK, Giroux DJ, Detterbeck F, Cardillo G, Edwards JG, Fong KM, Giuliani M, Huang J, Kernstine KH Sr, Marom EM, Nicholson AG, Van Schil PE, Travis WD, Tsao MS, Watanabe SI, Rusch VW, Asamura H; Members of the IASLC Staging and Prognostic Factors Committee and of the Advisory Boards, and Participating Institutions. The International Association for the Study of Lung Cancer Lung Cancer Staging Project: Proposals for Revision of the TNM Stage Groups in the Forthcoming (Ninth) Edition of the TNM Classification for Lung Cancer. J Thorac Oncol. 2024 Jul;19(7):1007-1027. doi: 10.1016/j.jtho.2024.02.011. Epub 2024 Mar 4.
- Background: PubMed 37272513Wakelee H, Liberman M, Kato T, Tsuboi M, Lee SH, Gao S, Chen KN, Dooms C, Majem M, Eigendorff E, Martinengo GL, Bylicki O, Rodriguez-Abreu D, Chaft JE, Novello S, Yang J, Keller SM, Samkari A, Spicer JD; KEYNOTE-671 Investigators. Perioperative Pembrolizumab for Early-Stage Non-Small-Cell Lung Cancer. N Engl J Med. 2023 Aug 10;389(6):491-503. doi: 10.1056/NEJMoa2302983. Epub 2023 Jun 3.
- Background: PubMed 37870974Heymach JV, Harpole D, Mitsudomi T, Taube JM, Galffy G, Hochmair M, Winder T, Zukov R, Garbaos G, Gao S, Kuroda H, Ostoros G, Tran TV, You J, Lee KY, Antonuzzo L, Papai-Szekely Z, Akamatsu H, Biswas B, Spira A, Crawford J, Le HT, Aperghis M, Doherty GJ, Mann H, Fouad TM, Reck M; AEGEAN Investigators. Perioperative Durvalumab for Resectable Non-Small-Cell Lung Cancer. N Engl J Med. 2023 Nov 2;389(18):1672-1684. doi: 10.1056/NEJMoa2304875. Epub 2023 Oct 23.
- Background: PubMed 35403841Forde PM, Spicer J, Lu S, Provencio M, Mitsudomi T, Awad MM, Felip E, Broderick SR, Brahmer JR, Swanson SJ, Kerr K, Wang C, Ciuleanu TE, Saylors GB, Tanaka F, Ito H, Chen KN, Liberman M, Vokes EE, Taube JM, Dorange C, Cai J, Fiore J, Jarkowski A, Balli D, Sausen M, Pandya D, Calvet CY, Girard N; CheckMate 816 Investigators. Neoadjuvant Nivolumab plus Chemotherapy in Resectable Lung Cancer. N Engl J Med. 2022 May 26;386(21):1973-1985. doi: 10.1056/NEJMoa2202170. Epub 2022 Apr 11.
- Background: PubMed 28885881Antonia SJ, Villegas A, Daniel D, Vicente D, Murakami S, Hui R, Yokoi T, Chiappori A, Lee KH, de Wit M, Cho BC, Bourhaba M, Quantin X, Tokito T, Mekhail T, Planchard D, Kim YC, Karapetis CS, Hiret S, Ostoros G, Kubota K, Gray JE, Paz-Ares L, de Castro Carpeno J, Wadsworth C, Melillo G, Jiang H, Huang Y, Dennis PA, Ozguroglu M; PACIFIC Investigators. Durvalumab after Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer. N Engl J Med. 2017 Nov 16;377(20):1919-1929. doi: 10.1056/NEJMoa1709937. Epub 2017 Sep 8.
- Individual participant dataSharing planned: Undecided. Individual participant data are not planned to be publicly shared because of privacy, ethical, and legal considerations. The study includes sensitive clinical, imaging, and biomarker data, and the relatively small sample size may increase the risk of participant re-identification. Summary statistical data may be obtained from the Principal Investigator upon reasonable request and with approval from the Ethics Committee.
Related trials for Unresectable Stage III Non-small Cell Lung Cancer
Not yet recruiting
Moderately Hypofractionated Versus Conventional Chemoradiotherapy With Consolidation Immunotherapy in Patients With Unresectable, Non-Targetable Stage III Non Small Cell Lung Cancer (NSCLC)
Stage III NSCLC
RecruitingPhase 3
A Study to Evaluate Pumitamig Versus Durvalumab Following Concurrent Chemoradiation Therapy in Participants With Unresectable Stage III Non-small Cell Lung Cancer (NSCLC) (ROSETTA Lung-201)
Non-small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 3
A Global Study to Assess the Effects of Durvalumab With Oleclumab or Durvalumab With Monalizumab Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer
Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
Trial to Evaluate Acasunlimab and Pembrolizumab Combination Superiority Over Standard of Care Docetaxel in Non-Small Cell Lung Cancer (ABBIL1TY NSCLC-06)
PD-L1-positive, Locally Advanced (Unresectable Stage IIIB/C) or Metastatic NSCLC
RecruitingPhase 2
A Study of JNJ-90301900 in Combination With Chemoradiation Followed by Consolidation Immunotherapy for Non-Small Cell Lung Cancer (NSCLC)
Carcinoma, Non-Small-Cell Lung
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.
Xuegang Yang, MD principal investigator
Sichuan Cancer Hospital and Research Institute
Guohui Xu, MD study chair
Sichuan Cancer Hospital and Research Institute
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, Intravenous Chemotherapy and Bronchial Artery Chemoembolization (BACE) in people with Unresectable Stage III Non-small Cell Lung Cancer and Tislelizumab, run by Sichuan Cancer Hospital and Research Institute 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 13 inclusion and 13 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: opening soon, as of the sponsor's last update on 1 May 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 Xuegang Yang, MD (+8613683476844, yanggangxue@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-Year Event-Free Survival (EFS) Rate (time frame: 1 year after the first dose of study treatment). 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 NCT07561983, 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 1 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.