Tislelizumab Plus Chemotherapy and BACE for Unresectable NSCLC (BEACON-Lung)
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.
調査の概要
状態
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究連絡先
- 名前:Xuegang Yang, MD
- 電話番号:+8613683476844
- メール:yanggangxue@163.com
研究場所
-
-
Sichuan
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Chengdu、Sichuan、中国、610041
- Sichuan Cancer Hospital and Research Institute
-
コンタクト:
- Guohui Xu
- 電話番号:+8613708010123
- メール:xgh0913@hotmail.com
-
コンタクト:
- Xuegang Yang, MD
- 電話番号:+8613683476844
- メール:yanggangxue@163.com
-
主任研究者:
- Xuegang Yang, MD
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的:Tislelizumab Plus Chemotherapy and 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.
|
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 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.
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.
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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1-Year Event-Free Survival (EFS) Rate
時間枠:1 year after the first dose of study treatment
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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.
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1 year after the first dose of study treatment
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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R0 Resection Rate
時間枠:Up to approximately 20 weeks after the first dose of study treatment
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The proportion of participants who undergo curative-intent surgery and achieve microscopically margin-negative (R0) resection after conversion treatment.
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Up to approximately 20 weeks after the first dose of study treatment
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Objective Response Rate (ORR)
時間枠:Up to approximately 30 months after the first dose of study treatment.
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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.
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Up to approximately 30 months after the first dose of study treatment.
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Pathologic Complete Response (pCR) Rate
時間枠:At the time of surgery, up to approximately 20 weeks after the first dose of study treatment.
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The proportion of participants who undergo surgery and have no residual viable tumor cells in the resected primary tumor and all resected lymph nodes.
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At the time of surgery, up to approximately 20 weeks after the first dose of study treatment.
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Major Pathologic Response (MPR) Rate
時間枠:At the time of surgery, up to approximately 20 weeks after the first dose of study treatment.
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The proportion of participants who undergo surgery and have 10% or less residual viable tumor cells in the resected primary tumor.
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At the time of surgery, up to approximately 20 weeks after the first dose of study treatment.
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Event-Free Survival (EFS)
時間枠:From the first dose of study treatment up to approximately 30 months
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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.
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From the first dose of study treatment up to approximately 30 months
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Overall Survival (OS)
時間枠:From the first dose of study treatment up to approximately 30 months.
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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.
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From the first dose of study treatment up to approximately 30 months.
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Incidence of Adverse Events
時間枠:From the first dose of study treatment up to approximately 30 months.
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Incidence, severity, relationship to study treatment, and outcomes of adverse events assessed according to NCI-CTCAE version 5.0.
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From the first dose of study treatment up to approximately 30 months.
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協力者と研究者
捜査官
- 主任研究者:Xuegang Yang, MD、Sichuan Cancer Hospital and Research Institute
- スタディチェア:Guohui Xu, MD、Sichuan Cancer Hospital and Research Institute
出版物と役立つリンク
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- Sorin 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.
- 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.
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- 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.
- 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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研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
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追加の関連 MeSH 用語
その他の研究ID番号
- KY-2025-346-03
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