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A Study to Investigate Treatment Patterns and Effectiveness of Tislelizumab in European Patients With Resectable or Advanced Non-Small Cell Lung Cancer (NSCLC) and Small Cell Lung Cancer (SCLC) (TITANS)

2026년 6월 11일 업데이트: BeOne Medicines

A Real-World Evaluation of Tislelizumab Treatment Patterns and Effectiveness in European Patients With Resectable or Advanced Non-Small Cell Lung Cancer and Small Cell Lung Cancer

The purpose of this study is to collect real-world data on treatment patterns and clinical outcomes in European patients receiving tislelizumab in routine clinical practice

연구 개요

상태

모병

정황

개입 / 치료

연구 유형

관찰

등록 (추정된)

440

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 스페인
      • Segovia, 스페인
        • 모병
        • Hospital General de Segovia

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

샘플링 방법

비확률 샘플

연구 인구

Participants with Resectable or Advanced Non-Small Cell Lung Cancer and Extensive-Stage Small Cell Lung Cancer in Europe receiving Tislelizumab in routine clinical practice

설명

Inclusion Criteria:

  • Participants are eligible to be included in the study only if they meet all the following criteria:

    1. Participants or their legal representative must sign written inform consent form (ICF)
    2. Participants receive tislelizumab as part of routine clinical practice as determined by the treating physician per standard of care and in accordance with the SmPC, within the approved indications in the 4 cohorts described.

Note: The decision to treat the patient with a tislelizumab-based regimen, as per its authorized indication, must have been made by the treating physician prior to and independent of the patient's consideration for participation in this study.

Exclusion Criteria:

  • Participants are excluded from the study if they meet any of the following criteria:

    1. Participants who are unable to understand all implications of study participation.
    2. Participants who have contraindications for treatment with tislelizumab in the investigator's opinion or have any contraindication as listed in the SmPC of tislelizumab.
    3. Participants who are deemed ineligible according to the investigator's opinion and the SmPC of tislelizumab.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
개입 / 치료
Cohort 1: Resectable NSCLC at High Risk of Recurrence
Neoadjuvant treatment and then adjuvant treatment for adult patients with resectable NSCLC at high risk of recurrence
의약품: Tislelizumab
Administered as part of routine clinical practice as determined by the treating physician in accordance with the summary of product characteristics (SmPC) and local standard of care
Cohort 2: Non-squamous NSCLC and Programmed Death Ligand 1 (PD-L1) ≥ 50%
First-line treatment of adult patients with non-squamous NSCLC whose tumors have PD-L1 expression on ≥50% of tumor cells with no EGFR or ALK positive mutations and who have locally advanced NSCLC and are not candidates for surgical resection or platinum-based chemoradiation, or metastatic NSCLC
의약품: Tislelizumab
Administered as part of routine clinical practice as determined by the treating physician in accordance with the summary of product characteristics (SmPC) and local standard of care
Cohort 3: Locally Advanced or Metastatic Squamous NSCLC
First-line treatment of adult patients with squamous NSCLC who have locally advanced NSCLC and are not candidates for surgical resection or platinum-based chemoradiation, or metastatic NSCLC
의약품: Tislelizumab
Administered as part of routine clinical practice as determined by the treating physician in accordance with the summary of product characteristics (SmPC) and local standard of care
Cohort 4: Extensive-Stage-SCLC
First-line treatment of adult patients with ES-SCLC
의약품: Tislelizumab
Administered as part of routine clinical practice as determined by the treating physician in accordance with the summary of product characteristics (SmPC) and local standard of care

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
기간
Time from Diagnosis to First Dose
기간: From date of first tislelizumab administration up to 30 months
From date of first tislelizumab administration up to 30 months
Duration of Treatment
기간: From date of first tislelizumab administration up to 30 months
From date of first tislelizumab administration up to 30 months
Number of Participants with Dose Modifications
기간: From date of first tislelizumab administration up to 30 months
From date of first tislelizumab administration up to 30 months
Number of Participants with Treatment Discontinuation
기간: From date of first tislelizumab administration up to 30 months
From date of first tislelizumab administration up to 30 months

2차 결과 측정

결과 측정
측정값 설명
기간
Real-world Pathological Complete Response (rwpCR) in Cohort 1
기간: From date of first tislelizumab administration up to 30 months
The rwpCR is defined as the percentage of participants with resectable NSCLC who, according to available local surgical pathology reports as per routine clinical practice, demonstrate no residual viable tumor cells in the resected primary tumor and lymph nodes after neoadjuvant tislelizumab treatment.
From date of first tislelizumab administration up to 30 months
Real-world Objective Response Rate (rwORR) in Cohorts 2, 3 and 4
기간: From date of first tislelizumab administration up to 30 months
The rwORR is defined as the percentage of participants with non-squamous NSCLC, squamous NSCLC, ES-SCLC, respectively, achieving a best overall response of complete or partial response (CR) or (PR) to tislelizumab, as assessed by the treating physician based on routine clinical documentation
From date of first tislelizumab administration up to 30 months
Real-world Overall Survival (rwOS)
기간: At selected landmark timepoints 12-month and 18-month
The rwOS is defined as the time from the date of first dose of study treatment to the date of death due to any cause.
At selected landmark timepoints 12-month and 18-month
Real-world Pathological Complete Response (rwpCR) by Programmed Death Ligand 1 (PD-L1) Level
기간: From date of first tislelizumab administration up to 30 months
The efficacy outcome will be summarized within PD-L1 subgroups using descriptive statistics
From date of first tislelizumab administration up to 30 months
Real-world Objective Response Rate (rwORR) by PD-L1 Level
기간: From date of first tislelizumab administration up to 30 months
The efficacy outcome will be summarized within PD-L1 subgroups using descriptive statistics
From date of first tislelizumab administration up to 30 months
Real-world Overall Survival (rwOS) by PD-L1 Level
기간: From date of first tislelizumab administration up to 30 months
The efficacy outcome will be summarized within PD-L1 subgroups using descriptive statistics
From date of first tislelizumab administration up to 30 months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

BeOne Medicines

수사관

  • 연구 책임자: Study Director, BeOne Medicines

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 6월 5일

기본 완료 (추정된)

2027년 11월 15일

연구 완료 (추정된)

2030년 11월 17일

연구 등록 날짜

최초 제출

2026년 6월 4일

QC 기준을 충족하는 최초 제출

2026년 6월 11일

처음 게시됨 (실제)

2026년 6월 17일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 17일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 11일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • BGB-A317-MA-EU-401

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved.

BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations.

Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.

IPD 공유 기간

See plan description

IPD 공유 액세스 기준

See plan description

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • ICF
  • CSR

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

진행성 비소세포폐암에 대한 임상 시험

Tislelizumab에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Argentina

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다