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

24 aprile 2026 aggiornato da: 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.

Panoramica dello studio

Tipo di studio

Interventistico

Iscrizione (Stimato)

39

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

    • Sichuan
      • Chengdu, Sichuan, Cina, 610041
        • Sichuan Cancer Hospital and Research Institute
        • Contatto:
        • Contatto:
        • Investigatore principale:
          • Xuegang Yang, MD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
1-Year Event-Free Survival (EFS) Rate
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
R0 Resection Rate
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Xuegang Yang, MD, Sichuan Cancer Hospital and Research Institute
  • Cattedra di studio: Guohui Xu, MD, Sichuan Cancer Hospital and Research Institute

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 maggio 2026

Completamento primario (Stimato)

31 ottobre 2028

Completamento dello studio (Stimato)

31 dicembre 2028

Date di iscrizione allo studio

Primo inviato

24 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

24 aprile 2026

Primo Inserito (Effettivo)

1 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

1 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

24 aprile 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • KY-2025-346-03

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Descrizione del piano IPD

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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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