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Trastuzumab Rezetecan and Adebrelimab, Alone or in Combination, After Chemoradiotherapy for HER2-Altered Unresectable Stage III Lung Cancer

2026년 9월 17일 업데이트: Ming Chen

A Randomized, Open-label, Multicenter, Phase II Study of Trastuzumab Rezetecan With Adebrelimab, Trastuzumab Rezetecan Alone and Adebrelimab Alone as Consolidation Therapy in Patients With Unresectable Stage III Non-Small Cell Lung Cancer Harboring HER2 Alterations Without Progression After Definitive Chemoradiotherapy

A randomized phase II study to assess the efficacy and safety of Trastuzumab Rezetecan and/or Adebrelimab as consolidation therapy following chemoradiotherapy in patients with unresectable stage III HER2-altered NSCLC.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

This is a randomized, open-label, multi-center phase II study evaluating the efficacy and safety of consolidation therapy with Trastuzumab Rezetecan combined with Adebrelimab versus Trastuzumab Rezetecan monotherapy versus Adebrelimab monotherapy in patients with unresectable stage III NSCLC harboring HER2 alterations (mutation or overexpression) who have not progressed after definitive concurrent or sequential chemoradiotherapy. Eligible patients will be randomized in a 1:1:1 ratio to receive either combination therapy, SHR-A1811 alone, or Adebrelimab alone for up to 12 months. The primary endpoint is progression-free survival (PFS) per RECIST v1.1.

연구 유형

중재적

등록 (추정된)

105

단계

  • 2 단계

연락처 및 위치

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

연구 연락처

연구 연락처 백업

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

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  1. Age ≥18 years.
  2. ECOG performance status 0-1.
  3. Histologically or cytologically confirmed Non-Small Cell Lung Cancer (NSCLC).
  4. Radiologically confirmed unresectable Stage III NSCLC per AJCC 9th edition.
  5. Pathologically confirmed HER2 mutation or HER2 overexpression (IHC 2+ or 3+).
  6. Life expectancy ≥3 months.
  7. Completed at least two cycles of platinum-based chemotherapy (concurrent or sequential) with definitive radiotherapy. Consolidation chemotherapy after radiotherapy is not permitted; chemotherapy with or without immunotherapy before concurrent chemoradiotherapy is permitted.
  8. Total radiotherapy dose 60 Gy ± 10% (54-66 Gy) using IMRT (preferred) or 3D-CRT, with acceptable dosimetric constraints.
  9. Adequate organ and bone marrow function.
  10. Negative pregnancy test for women of childbearing potential within 7 days prior to first dose. Willing to use effective contraception during the study and for 180 days after the last dose.
  11. Signed informed consent form (ICF).

Exclusion Criteria:

  1. Known EGFR-activating mutations or ALK fusions.
  2. Presence of other driver gene mutations with approved targeted therapies available.
  3. Mixed SCLC and NSCLC, large cell neuroendocrine carcinoma, or sarcomatoid carcinoma.
  4. Prior treatment with HER2-targeted ADCs or HER2 TKIs.
  5. Malignant pleural effusion, pericardial effusion, or ascites.
  6. Participation in another clinical trial within 4 weeks or 5 half-lives prior to first dose.
  7. Systemic immunosuppressive therapy within 2 weeks prior to first dose.
  8. Known HIV infection.
  9. Active hepatitis B (HBsAg positive with detectable HBV-DNA and ALT > ULN) or active hepatitis C.
  10. Active autoimmune disease requiring systemic treatment.
  11. Other malignancies within 5 years, except adequately treated cervical carcinoma in situ, basal/squamous cell skin carcinoma, localized prostate cancer, or ductal carcinoma in situ.
  12. Active or history of Grade ≥2 radiation pneumonitis per RTOG/EORTC, or symptomatic interstitial lung disease. Participants with grade 2 radiation pneumonitis that resolves to grade 1 or lower within 14 days without systemic glucocorticoid treatment may undergo screening if the investigator considers there to be no risk of recurrence.
  13. Significant cardiovascular disease.
  14. Severe infection within 4 weeks prior to first dose.
  15. Prior or planned allogeneic bone marrow or solid organ transplantation.
  16. Live attenuated vaccine within 28 days prior to first dose or planned during study. Pregnancy or breastfeeding.
  17. Known hypersensitivity to Adebrelimab, Trastuzumab Rezetecan, or any excipients.
  18. Known history of psychotropic substance abuse, alcohol abuse, or illicit drug use.
  19. Any condition that might impair the subject's ability to comply with study requirements.

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
실험적: Arm A (Combination Therapy)

Drug: Trastuzumab Rezetecan + Adebrelimab
의약품: Trastuzumab Rezetecan (SHR-A1811) + Adebrelimab

Trastuzumab Rezetecan (4.8mg/kg, iv, d1, Q3W) and Adebrelimab (1200mg, iv, d1, Q3W). Treatment will continue for up to 12 months or until disease progression, unacceptable toxicity, or other criteria for treatment discontinuation are met.
실험적: Arm B (Targeted Monotherapy)

Drug: Trastuzumab Rezetecan
의약품: Trastuzumab Rezetecan (SHR-A1811)

Trastuzumab Rezetecan (4.8mg/kg, iv, d1, Q3W). Treatment will continue for up to 12 months or until disease progression, unacceptable toxicity, or other criteria for treatment discontinuation are met.
실험적: Arm C (Immunotherapy Monotherapy)

Drug: Adebrelimab
의약품: Adebrelimab

Adebrelimab (1200mg, iv, d1, Q3W). Treatment will continue for up to 12 months or until disease progression, unacceptable toxicity, or other criteria for treatment discontinuation are met.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Progression-Free Survival (PFS)
기간: Assessed up to approximately 36 months.

Defined as the time from randomization to disease progression or death from any cause, whichever occurs first.
Assessed up to approximately 36 months.

2차 결과 측정

결과 측정
측정값 설명
기간
Overall Survival (OS)
기간: Assessed up to approximately 60 months.

Defined as the time from randomization to death from any cause.
Assessed up to approximately 60 months.
Objective Response Rate (ORR)
기간: Assessed up to approximately 36 months.

Defined as the proportion of participants whose best overall response (BOR) is complete response (CR) or partial response (PR), as assessed according to RECIST v1.1.
Assessed up to approximately 36 months.
Duration of Response (DoR)
기간: Assessed up to approximately 36 months.

Defined as the time from the first documented response (CR or PR) to the first documented disease progression (PD) or death from any cause, whichever occurs first.
Assessed up to approximately 36 months.
Disease Control Rate (DCR)
기간: Assessed up to approximately 36 months.

Defined as the proportion of participants who achieve complete response (CR), partial response (PR), or stable disease (SD) following treatment, as assessed according to RECIST v1.1.
Assessed up to approximately 36 months.
Time to Death or Distant Metastasis (TTDM)
기간: Assessed up to approximately 36 months.

Defined as the time from randomization to the first occurrence of distant metastasis or death from any cause.
Assessed up to approximately 36 months.
Progression-Free Survival Rate at 6 Months
기간: 6 months after randomization.

Kaplan-Meier estimate of the percentage of participants alive without disease progression at 6 months after randomization.
6 months after randomization.
Progression-Free Survival Rate at 12 Months
기간: 12 months after randomization.

Kaplan-Meier estimate of the percentage of participants alive without disease progression at 12 months after randomization.
12 months after randomization.
Overall Survival Rate at 12 Months
기간: 12 months after randomization.

Kaplan-Meier estimate of the percentage of participants alive at 12 months after randomization.
12 months after randomization.
Overall Survival Rate at 24 Months
기간: 24 months after randomization.

Kaplan-Meier estimate of the percentage of participants alive at 24 months after randomization.
24 months after randomization.
Incidence of Adverse Events (AEs)
기간: Assessed up to approximately 36 months.

AEs graded by CTCAE version 6.0
Assessed up to approximately 36 months.

기타 결과 측정

결과 측정
기간
Patients reported disease-related symptoms and HRQoL by the EORTC QLQ-C30 questionnaires
기간: Assessed up to approximately 36 months.
Assessed up to approximately 36 months.
Patients reported disease-related symptoms and HRQoL by the EORTC QLQ-LC13 questionnaires
기간: Assessed up to approximately 36 months.
Assessed up to approximately 36 months.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Ming Chen

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)

2026년 9월 1일

기본 완료 (추정된)

2029년 12월 1일

연구 완료 (추정된)

2031년 12월 1일

연구 등록 날짜

최초 제출

2026년 9월 13일

QC 기준을 충족하는 최초 제출

2026년 9월 17일

처음 게시됨 (실제)

2026년 9월 23일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 23일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 17일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • MA-NSCLC-II-064

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

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. .

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