A Study to Assess Intravenous (IV) Telisotuzumab Adizutecan Compared to Standard of Care in Adult Participants Previously Treated, EGFR Wildtype, Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer
2026년 9월 10일 업데이트: AbbVie
A Phase 3 Open Label Randomized Study of Telisotuzumab Adizutecan Compared to Standard of Care in Subjects With Previously Treated, EGFR Wildtype, Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer Expressing c-Met Protein Level Above a Defined Cutoff
Non-small cell lung cancer (NSCLC) is a common type of lung cancer where abnormal cells in the lungs grow out of control. The purpose of this study is to evaluate whether telisotuzumab adizutecan improves response rate and overall survival compared to standard of care in participants with epidermal growth factor receptor (EGFR) wildtype non-squamous NSCLC who have high c-Met protein expression and have progressed after standard therapies.
Telisotuzumab adizutecan is an investigational drug being developed for the treatment of NSCLC. This is an open-label study where participants and doctors know which treatment is being administered. Participants are randomized into 2 groups called treatment arms. One group will receive telisotuzumab adizutecan, while the other group will receive standard of care (SOC) treatment consisting of Docetaxel or Docetaxel with Ramucirumab. Around 660 participants will be enrolled in the study at approximately 250 sites worldwide.
Participants will receive either doses of Intravenous (IV) telisotuzumab adizutecan or IV SOC of docetaxel alone or docetaxel with ramucirumab. The study will run for a duration of approximately 50 months.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.
연구 개요
연구 유형
중재적
등록 (추정된)
660
단계
- 3단계
연락처 및 위치
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연구 연락처
- 이름: ABBVIE CALL CENTER
- 전화번호: 844-663-3742
- 이메일: abbvieclinicaltrials@abbvie.com
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
설명
Inclusion Criteria:
- Histologically or cytologically confirmed metastatic/locally advanced non-squamous NSCLC
- Known EGFR activating mutation status (EGFR wildtype only; participants with EGFR activating mutations are not eligible)
- Cellular-mesenchymal epithelial transition (c-Met) Immunohistochemistry (IHC) staining as assessed by AbbVie designated IHC Laboratory
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1
- At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 that has not been previously irradiated
Exclusion Criteria:
- Participant tumor(s) has (have) mixed adenosquamous or squamous or neuroendocrine histology or sarcomatoid features
- Known active/symptomatic brain metastases
- History of interstitial lung disease (ILD) or pneumonitis that required systemic steroids
- Major, life-threatening medical conditions with life expectancy less than 3 months
- Clinically significant medical conditions or other reasons that would interfere with study participation
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Telisotuzumab Adizutecan
Participants will receive telisotuzumab adizutecan until meeting study drug discontinuation criteria.
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정맥 내 (IV)
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활성 비교기: Standard of care (SOC)
Participants will receive SOC docetaxel or docetaxel plus ramucirumab until meeting study drug discontinuation criteria.
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정맥 주사
IV
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Objective Response (OR) Based on Blinded Independent Central Review (BICR) Assessment Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
기간: Up to Approximately 24 Months
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OR is defined as participants achieving a best overall response of confirmed complete response (CR) or partial response (PR) per BICR based on RECIST version 1.1.
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Up to Approximately 24 Months
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Overall Survival (OS)
기간: Up to Approximately 50 Months
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OS is defined as the time from date of randomization to the event of death from any cause.
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Up to Approximately 50 Months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Progression-Free Survival (PFS) Based on BICR Assessment Per RECIST Version 1.1
기간: Up to Approximately 24 Months
|
PFS is defined as the time from date of randomization to the first occurrence of radiographic progression based on RECIST v1.1 or death from any cause, whichever occurs earlier.
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Up to Approximately 24 Months
|
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Duration of Response (DoR) Based on BICR Assessment Per RECIST Version 1.1
기간: Up to Approximately 24 Months
|
DoR defined as time from the date of initial response of confirmed CR or PR to the first occurrence of radiographic progression per RECIST v1.1 or death from any cause, whichever occurs first.
DoR is defined for subjects with confirmed CR/PR.
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Up to Approximately 24 Months
|
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Disease Control (DC) Based on BICR Assessment Per RECIST Version 1.1
기간: Up to Approximately 24 Months
|
DC is defined as best overall response of confirmed CR or confirmed PR, or stable disease (SD) based on RECIST, v1.1
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Up to Approximately 24 Months
|
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Change From Baseline in Physical Functioning as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
기간: Up to Week 12
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The EORTC QLQ-C30 is a 30-item patient-reported questionnaire composed of both multi-item and single scales including 5 functional scales, 3 symptom scales, a global health status/QoL scale, and 6 single items.
Participants rate items on a 4-point scale ranging from 1 (not at all) to 4 (very much).
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Up to Week 12
|
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Change From Baseline in Key Lung Cancer Symptoms as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13)
기간: Up to Week 12
|
The EORTC QLQ-LC13 is a lung cancer specific module and consists of 13 questions assessing lung cancer-associated symptoms and treatment-related effects, including one multiple-item scale to assess dyspnea and a series of single items assessing coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain, and pain medication.
Each item is assessed on a Likert scale from 1 (not at all) to 4 (very much).
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Up to Week 12
|
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Change From Baseline in Global Health Status/Quality of Life (GHS/QoL) as Measured by the EORTC QLQ-C30
기간: Up to Week 12
|
Health-related quality-of-life and symptoms will be assessed with the EORTC QLQ-C30.
The EORTC QLQ-C30 is a 30-item patient-reported questionnaire composed of both multi-item and single scales including 5 functional scales (physical, role, emotional, social, and cognitive), 3 symptom scales (fatigue, nausea and vomiting, and pain), a GHS/QoL scale, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties).
Participants rate items on a 4 point scale ranging from 1 to 4 (1 = Not at All, 2 = A Little, 3 = Quite a Bit, and 4 = Very Much).
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Up to Week 12
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 연구 책임자: ABBVIE INC., AbbVie
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 (추정된)
2027년 1월 6일
기본 완료 (추정된)
2031년 4월 1일
연구 완료 (추정된)
2031년 4월 1일
연구 등록 날짜
최초 제출
2026년 9월 10일
QC 기준을 충족하는 최초 제출
2026년 9월 10일
처음 게시됨 (실제)
2026년 9월 16일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 9월 16일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 9월 10일
마지막으로 확인됨
2026년 9월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- M26-167
- 2025 (미국 NIH 보조금/계약: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
- 2025-524802-13-00 (기타 식별자: EU CT)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
AbbVie is committed to responsible clinical trial data sharing.
This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
IPD 공유 기간
For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
IPD 공유 액세스 기준
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
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