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Tislelizumab Plus Chemotherapy and BACE for Unresectable NSCLC (BEACON-Lung)

2026年4月24日 更新者:Guohui Xu、Sichuan Cancer Hospital and Research Institute

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

研究の種類

介入

入学 (推定)

39

段階

  • フェーズ2

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

    • Sichuan
      • Chengdu、Sichuan、中国、610041
        • Sichuan Cancer Hospital and Research Institute
        • コンタクト:
        • コンタクト:
        • 主任研究者:
          • Xuegang Yang, MD

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

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

いいえ

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

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

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
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.

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
1-Year Event-Free Survival (EFS) Rate
時間枠: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.
1 year after the first dose of study treatment

二次結果の測定

結果測定
メジャーの説明
時間枠
R0 Resection Rate
時間枠:Up to approximately 20 weeks after the first dose of study treatment
The proportion of participants who undergo curative-intent surgery and achieve microscopically margin-negative (R0) resection after conversion treatment.
Up to approximately 20 weeks after the first dose of study treatment
Objective Response Rate (ORR)
時間枠:Up to approximately 30 months after the first dose of study treatment.
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.
Up to approximately 30 months after the first dose of study treatment.
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.
The proportion of participants who undergo surgery and have no residual viable tumor cells in the resected primary tumor and all resected lymph nodes.
At the time of surgery, up to approximately 20 weeks after the first dose of study treatment.
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.
The proportion of participants who undergo surgery and have 10% or less residual viable tumor cells in the resected primary tumor.
At the time of surgery, up to approximately 20 weeks after the first dose of study treatment.
Event-Free Survival (EFS)
時間枠:From the first dose of study treatment up to approximately 30 months
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.
From the first dose of study treatment up to approximately 30 months
Overall Survival (OS)
時間枠:From the first dose of study treatment up to approximately 30 months.
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.
From the first dose of study treatment up to approximately 30 months.
Incidence of Adverse Events
時間枠:From the first dose of study treatment up to approximately 30 months.
Incidence, severity, relationship to study treatment, and outcomes of adverse events assessed according to NCI-CTCAE version 5.0.
From the first dose of study treatment up to approximately 30 months.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

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

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年5月1日

一次修了 (推定)

2028年10月31日

研究の完了 (推定)

2028年12月31日

試験登録日

最初に提出

2026年4月24日

QC基準を満たした最初の提出物

2026年4月24日

最初の投稿 (実際)

2026年5月1日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月1日

QC基準を満たした最後の更新が送信されました

2026年4月24日

最終確認日

2026年4月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

未定

IPD プランの説明

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.

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いいえ

米国FDA規制機器製品の研究

いいえ

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