이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

초기 비절제 비소세포폐암(NSCLC) 환자의 정위 체부 방사선 요법을 사용한 Durvalumab 대 위약 / EGFR 돌연변이를 지닌 초기 비절제 비소세포폐암 환자의 SBRT 후 오시머티닙 (PACIFIC-4)

2026년 11월 6일 업데이트: AstraZeneca

비절제 1기/2기 림프절 음성 비소세포 환자 치료를 위한 정위 체부 방사선 요법(SBRT)을 이용한 Durvalumab의 3상, 무작위, 위약 대조, 이중맹검, 다기관, 국제 연구 폐암(PACIFIC-4/RTOG-3515) 민감화 EGFR 돌연변이가 있는 절제되지 않은 I/II기 림프절 음성 NSCLC 환자를 위한 SBRT 후 단일 팔 코호트인 오시머티닙

This is a Phase III, randomized, placebo-controlled, double-blind, multi-center study assessing the efficacy and safety of durvalumab with SoC SBRT versus placebo with SoC SBRT in patients with unresected clinical Stage I/II lymph node-negative (T1 to T3N0M0) NSCLC.

An additional cohort will assess Osimertinib following SBRT in patients with early stage unresected T1 to T3N0M0 NSCLC harbouring an EGFR mutation.

연구 개요

상태

모집하지 않고 적극적으로

정황

개입 / 치료

상세 설명

Patients with Stage I/II lymph node negative NSCLC and confirmed to meet all eligibility criteria will be randomized 1:1 to receive either Durvalumab + SoC SBRT or placebo + SoC SBRT.

The primary objective of main cohort is to assess the efficacy of Durvalumab with SoC SBRT compared to placebo with SoC SBRT in terms of PFS. Key secondary is to assess the efficacy of Durvalumab with SoC SBRT compared to placebo with SoC SBRT in terms of Overall Survival (OS).

In addition, a study cohort with a sufficient number of patients harboring an EGFR-TKI sensitizing mutation, will receive Osimertinib treatment after completion of SoC SBRT as definitive treatment of Stage I/II lymph node-negative NSCLC. The primary objective of Osimertinib cohort is to assess efficacy of Osimertinib following SoC SBRT in terms of 4-year PFS. Key secondary objectives include safety, OS and efficacy of Osimertininb treatment with SBRT.

연구 유형

중재적

등록 (실제)

724

단계

  • 3단계

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  • 벨기에
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      • Akashi-shi, 일본, 673-8558
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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 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Main Cohort Key Inclusion Criteria:

  1. Age ≥18 years
  2. Planned SoC SBRT as definitive treatment
  3. World Health Organization (WHO)/ECOG PS of 0, 1 or 2
  4. Life expectancy of at least 12 weeks
  5. Body weight >30 kg
  6. Submission of tumor tissue sample if available
  7. Adequate organ and marrow function required
  8. Patients with central or peripheral lesions are eligible
  9. Staging studies must be done during screening (PET-CT within 10 weeks)
  10. Patients with a history of metachronous NSCLC and synchronous lesions are eligible with some exceptions

Main Cohort Key Exclusion Criteria:

  1. Mixed small cell and non-small cell cancer
  2. History of allogeneic organ transplantation
  3. History of another primary malignancy with exceptions
  4. History of active primary immunodeficiency
  5. Epidermal growth factor receptor local testing is strongly recommended prior to enrollment. Patients with a tumor harboring an EGFRm per local testing will be excluded from the main cohort
  6. Prior exposure to immune-mediated therapy with exceptions

Osimertinib Cohort Key Inclusion Criteria

  1. Age ≥18 years
  2. Planned SoC SBRT as definitive treatment
  3. WHO/ECOG PS of 0, 1, or 2
  4. Patients with central or peripheral lesions are eligible
  5. Patients with a history of metachronous NSCLC and synchronous lesions are eligible with some exceptions
  6. Staging studies must be done during screening (PET-CT within 10 weeks)
  7. Submission of tumor tissue sample if available
  8. Confirmation by local laboratory that the tumor harbors one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R)
  9. Adequate bone marrow reserve or organ function required
  10. Female patients should be using highly effective contraceptive measures
  11. Male patients should be asked to use barrier contraceptives (ie, condoms) during sex with all partners during the trial and avoid procreation

Osimertinib Cohort Key Exclusion Criteria

  1. Mixed small cell and non-small cell cancer

  2. Patients with known or increased risk factor for QTc prolongation

  3. Treatment with any of the following:

    • Preoperative or adjuvant platinum-based or other chemotherapy for the disease under investigation
    • Prior treatment with neoadjuvant or adjuvant EGFR TKI
    • Patients currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be potent inducers of CYP3A4

  4. Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of osimertinib

  5. Any of the following cardiac criteria

    • Mean resting corrected QT interval >470 msec, obtained from 3 ECGs
    • Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG.
    • Any factors that increase the risk of QTc prolongation or risk of arrhythmic events, or unexplained -sudden death under 40 years of age in first-degree relatives or any concomitant medication known to prolong the QT interval
    • Past medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD

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: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: SoC SBRT + Durvalumab Therapy (Main Cohort)

SBRT

Durvalumab (PD-L1 monoclonal antibody) 1500 mg every 4 weeks [q4w] intravenously [iv] for up to 26 cycles or until progression or other discontinuation criteria are met.
의약품: Durvalumab

Durvalumab 1500 mg every 4 weeks [q4w] intravenously [iv] for up to 26 cycles or until progression or other discontinuation criteria are met.

다른 이름들:
  • 메디4736
위약 비교기: SoC SBRT + Placebo Therapy (Main Cohort)

SBRT

Placebo (matching placebo for infusion) every 4 weeks iv for up to 26 cycles or until progression or other discontinuation criteria are met.
다른: Placebo

Matching placebo for infusion every 4 weeks iv for up to 26 cycles or until progression or other discontinuation criteria are met.
실험적: SoC SBRT + Osimertinib Therapy (Osimertinib cohort, single-arm, open-label separate cohort)

SBRT

Osimertinib 80mg every day [qd] for oral administration up to 36 months or until progression. Osimertinib treatment should start within 7 to 14 days after completion of SBRT
의약품: (Osimertinib cohort, single-arm, open-label separate cohort)

Osimertinib 80 mg every day [qd] orally for up to 36 months or until progression or other discontinuation criteria are met. Osimertinib treatment should start from 7 to 14 days after completion of SBRT

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Progression-Free Survival (PFS) assessed by Blinded Independent Central Review (BICR) according to RECIST 1.1 in subpopulation of patients with Stage I/II NSCLC
기간: from randomization up to 6 years

Main Cohort
from randomization up to 6 years
4-year Progression-Free Survival (4y-PFS) by ICR according to RECIST 1.1 criteria
기간: from treatment start up to 5 years

Osimertinib Cohort
from treatment start up to 5 years

2차 결과 측정

결과 측정
측정값 설명
기간
Progression-Free Survival (PFS) assessed by BICR per RECIST 1.1 in all randomised patients with Stage I/II NSCLC
기간: from randomization up to 6 years

Main Cohort
from randomization up to 6 years
Overall Survival (OS)
기간: from randomization up to 7 years

Main Cohort
from randomization up to 7 years
Concentration of durvalumab in serum such as peak concentration and trough
기간: 12 weeks after last dose

Main Cohort
12 weeks after last dose
Detection of ADA neutralising antibodies titers
기간: up to 6 months after last dose

Main Cohort
up to 6 months after last dose
Health-related quality of life in patients treated with durvalumab with SoC SBRT compared to placebo with SoC SBRT using the EORTC QLQ-C30
기간: from randomization up to 7 years

Main Cohort
from randomization up to 7 years
Proportion of patients alive and progression free at 24 months from randomisation (PFS24) assessed by BICR according to RECIST 1.1
기간: at 24 months following randomization

Main Cohort
at 24 months following randomization
Time to progression (TTP) assessed by BICR according to RECIST 1.1
기간: from randomization up to 6 years

Main Cohort
from randomization up to 6 years
Time to death or distant metastasis (TTDM) assessed by BICR according to RECIST 1.1
기간: from randomization up to 6 years

Main Cohort
from randomization up to 6 years
Time from randomisation to second progression (PFS2) as defined by local standard clinical practice
기간: from randomization up to 7 years

Main Cohort
from randomization up to 7 years
Assessment of AEs by CTCAE v 5.0 as measures of the safety and tolerability of Durvalumab with SoC SBRT compared to placebo with SoC SBRT
기간: up to 3 months after last dose

Main Cohort
up to 3 months after last dose
Assessment of AEs by CTCAE v 5.0 as measures of the safety, tolerability and compliance of osimertinib with SoC SBRT therapy
기간: Up to 35 days after last dose

Osimertinib Cohort
Up to 35 days after last dose
WHO performance status
기간: from treatment start up to 5 years

Osimertinib Cohort
from treatment start up to 5 years
ECG QT interval
기간: Up to 156 weeks of treatment or treatment discontinuation

Osimertinib Cohort
Up to 156 weeks of treatment or treatment discontinuation
Overall Survival
기간: from treatment start up to 5 years

Osimertinib Cohort
from treatment start up to 5 years
Time To Progression (TTP)
기간: from treatment start up to 5 years

Osimertinib Cohort
from treatment start up to 5 years
Time to CNS progression
기간: from treatment start up to 5 years

Osimertinib Cohort
from treatment start up to 5 years
PFS2
기간: from treatment start up to 5 years

Osimertinib Cohort
from treatment start up to 5 years
Site(s) of disease progression
기간: from treatment start up to 5 years

Osimertinib Cohort
from treatment start up to 5 years
PFS by ICR using RECIST 1.1
기간: from treatment start up to 5 years

Osimertinib Cohort
from treatment start up to 5 years

기타 결과 측정

결과 측정
측정값 설명
기간
Lung cancer mortality
기간: from treatment start up to 5 years

Osimertinib Cohort
from treatment start up to 5 years
Lung Cancer Mortality
기간: from randomization Up to 5 years

Main Cohort
from randomization Up to 5 years

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

AstraZeneca

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

유용한 링크

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)

2019년 3월 6일

기본 완료 (추정된)

2028년 10월 31일

연구 완료 (추정된)

2028년 10월 31일

연구 등록 날짜

최초 제출

2019년 1월 25일

QC 기준을 충족하는 최초 제출

2019년 2월 5일

처음 게시됨 (실제)

2019년 2월 6일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 9일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 6일

마지막으로 확인됨

2026년 11월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • D9103C00001
  • 2018 (미국 NIH 보조금/계약)
  • 2018-002572-41 (EudraCT 번호)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD 공유 기간

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD 공유 액세스 기준

When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

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. .

구독하다