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

24. dubna 2026 aktualizováno: 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.

Přehled studie

Typ studie

Intervenční

Zápis (Odhadovaný)

39

Fáze

  • Fáze 2

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

    • Sichuan
      • Chengdu, Sichuan, Čína, 610041
        • Sichuan Cancer Hospital and Research Institute
        • Kontakt:
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Xuegang Yang, MD

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: N/A
  • Intervenční model: Přiřazení jedné skupiny
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
1-Year Event-Free Survival (EFS) Rate
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
R0 Resection Rate
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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.

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Vyšetřovatelé

  • Vrchní vyšetřovatel: Xuegang Yang, MD, Sichuan Cancer Hospital and Research Institute
  • Studijní židle: Guohui Xu, MD, Sichuan Cancer Hospital and Research Institute

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. května 2026

Primární dokončení (Odhadovaný)

31. října 2028

Dokončení studie (Odhadovaný)

31. prosince 2028

Termíny zápisu do studia

První předloženo

24. dubna 2026

První předloženo, které splnilo kritéria kontroly kvality

24. dubna 2026

První zveřejněno (Aktuální)

1. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

1. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

24. dubna 2026

Naposledy ověřeno

1. dubna 2026

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • KY-2025-346-03

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NEROZHODNÝ

Popis plánu 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.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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