Tislelizumab Plus Chemotherapy and BACE for Unresectable NSCLC

NCT07561983 | Not Yet Recruiting Phase 2

• 1 other identifier: KY-2025-346-03
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief 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). 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

Keywords

Unresectable Non-Small Cell Lung Cancer; Tislelizumab; Chemotherapy; Bronchial Artery Chemoembolization; Conversion Therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year after the first dose of study treatment

Secondary Outcomes (7)

• R0 Resection Rate

  Up to approximately 20 weeks after the first dose of study treatment

• Objective Response Rate (ORR)

  Up to approximately 30 months after the first dose of study treatment.

• Pathologic Complete Response (pCR) Rate

  At the time of surgery, up to approximately 20 weeks after the first dose of study treatment.

• Major Pathologic Response (MPR) Rate

  At the time of surgery, up to approximately 20 weeks after the first dose of study treatment.

• Event-Free Survival (EFS)

  From the first dose of study treatment up to approximately 30 months

Study Arms (1)

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.

Drug: Tislelizumab; Drug: Intravenous Chemotherapy; Procedure: Bronchial Artery Chemoembolization (BACE)

Interventions

Tislelizumab DRUG

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.

Tislelizumab Plus Chemotherapy and BACE

Intravenous Chemotherapy DRUG

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.

Tislelizumab Plus Chemotherapy and BACE

Bronchial Artery Chemoembolization (BACE) PROCEDURE

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.

Tislelizumab Plus Chemotherapy and BACE

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Sichuan Cancer Hospital and Research Institute: lead

Study Sites (1)

Sichuan Cancer Hospital and Research Institute

Chengdu, Sichuan, 610041, China

Location

Related Publications (12)

• 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.

  PMID: 41634290 BACKGROUND

• Zheng 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.

  PMID: 41680955 BACKGROUND

• Liang 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.

  PMID: 41548595 BACKGROUND

• Xiang 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.

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• Rami-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.

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MeSH Terms

Interventions

tislelizumab

Study Officials

• Xuegang Yang, MD

  Sichuan Cancer Hospital and Research Institute

  PRINCIPAL INVESTIGATOR

• Guohui Xu, MD

  Sichuan Cancer Hospital and Research Institute

  STUDY CHAIR

Central Study Contacts

Xuegang Yang, MD

CONTACT

+8613683476844; yanggangxue@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Chief Physician, Director of Department of Interventional Therapy

Study Record Dates

• First Submitted: April 24, 2026
• First Posted: May 1, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): October 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

CN (1)