Moderately Hypofractionated Versus Conventional Chemoradiotherapy With Consolidation Immunotherapy in Patients With Unresectable, Non-Targetable Stage III Non Small Cell Lung Cancer (NSCLC) (MODERN-LUNG)
Moderately Hypofractionated Versus Conventional Chemoradiotherapy With Consolidation Immunotherapy, in Patients With Unresectable, Non-Targetable Stage III NSCLC: A Phase III Randomised Controlled Trial
This is an open-label, multi-centre, phase 3 randomised controlled trial comparing 4 weeks with 6 weeks of Chemoradiotherapy (CRT) followed by consolidation immunotherapy in patients with unresectable, non-targetable stage 3 NSCLC given with curative intent.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Courtney Wheeler
- 전화번호: +61 2 40143911
- 이메일: MODERN-LUNG@trog.com.au
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Histologically proven Non-Small Cell Lung Carcinoma (NSCLC) including squamous cell carcinoma, adenocarcinoma or large cell undifferentiated carcinoma
- Stage III according to 9th edition of the AJCC/UICC TNM classification
- Unresectable
- Aged18 years or older
- Suitable for concurrent chemoradiotherapy
- Suitable for consolidation immunotherapy
- ECOG performance status 0-2
- Staging FDG-PET CT and CNS imaging within 6 weeks of randomisation
- Has provided written informed consent for participation in this trial
Exclusion Criteria:
- Targetable driver mutation
- Contraindication to curative dose radiotherapy
- Contraindication to chemotherapy
- Contraindication to immunotherapy
- Planned for induction or consolidation chemotherapy
- Previous thoracic radiotherapy with significant overlap
- Other active malignant disease interfering with completion of protocol treatment or outcomes
- Inability to attend for protocol follow-up
- Enrolled on another therapy clinical trial during treatment impacting outcomes
- Pregnant or lactating patients
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: ARM 1 - Moderately Hypofractionated Chemoradiotherapy (4 weeks)
Participants will receive moderately hypofractionated chemoradiotherapy with consolidation immunotherapy (60 Gy in 20 fractions to the primary tumour or 55 Gy in 20 fractions to involved lymph nodes (LN) 2.75 -3.0 Gy per fraction over 4 weeks). |
Participants will receive moderately hypofractionated chemoradiotherapy with consolidation immunotherapy (60 Gy in 20 fractions to the primary tumour or 55 Gy in 20 fractions to involved lymph nodes (LN) 2.75 -3.0 Gy per fraction over 4 weeks). |
|
활성 비교기: ARM 2 - Standard Chemoradiotherapy (6-6.5weeks)
Participants will receive conventionally fractionated chemoradiotherapy with consolidation immunotherapy (60Gy in 30 fractions of 66Gy in 33 fractions at 2 Gy per fraction over 6-7 weeks). |
Participants will receive conventionally fractionated chemoradiotherapy with consolidation immunotherapy (60Gy in 30 fractions of 66Gy in 33 fractions at 2 Gy per fraction over 6-7 weeks). |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Win Ratio Based on a Hierarchical Composite Endpoint
기간: From randomisation to 24 months, incorporating adverse events within 90 days of treatment commencement and healthcare contact days and quality-of-life changes within 90 days of randomisation.
|
The primary outcome is the win ratio comparing Arm 1 with Arm 2 using a hierarchical composite endpoint comprising the following components, assessed in order of priority: Progression-free survival (PFS) over 24 months, with a tie margin of 3 months. Thoracic-related adverse events assessed using CTCAE version 6.0 within 90 days of treatment commencement. Healthcare contact days within 90 days of randomisation, with a tie margin of 5 days. Change from baseline to 90 days in the EORTC QLQ-C30 global health status score, with a tie margin of 10 points. The win ratio will be used to assess whether Arm 1 is superior to Arm 2 based on the hierarchical comparison of these outcomes. |
From randomisation to 24 months, incorporating adverse events within 90 days of treatment commencement and healthcare contact days and quality-of-life changes within 90 days of randomisation.
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Progression free survival (PFS)
기간: From randomisation to disease progression or death from any cause, assessed up to 24 months.
|
Progression-free survival is defined as the time from randomisation to the first occurrence of disease progression or death from any cause, whichever occurs first. PFS will be compared between Arm 1 and Arm 2. |
From randomisation to disease progression or death from any cause, assessed up to 24 months.
|
|
Proportion of Participants Experiencing Grade ≥3 Thoracic-Related Adverse Events
기간: From treatment commencement to 90 days after treatment commencement.
|
The proportion of participants experiencing at least one Grade 3 or higher thoracic-related adverse event, assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 6.0. The proportion will be compared between Arm 1 and Arm 2. |
From treatment commencement to 90 days after treatment commencement.
|
|
Number of Healthcare Contact Days
기간: From randomisation to 90 days after randomisation.
|
The number of days with any hospital-based healthcare contact, including scheduled treatment attendances, inpatient hospitalisation days or emergency department presentations. Multiple healthcare contacts occurring on the same day will be counted as one healthcare contact day. The number of healthcare contact days will be compared between Arm 1 and Arm 2. |
From randomisation to 90 days after randomisation.
|
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Change From Baseline in Quality of Life Scores at 90 Days
기간: Baseline to 90 days after randomisation.
|
Change from baseline to 90 days in global health status/quality of life, assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). The global health status/quality of life scale is scored from 0 to 100, with higher scores indicating better global health status and quality of life. |
Baseline to 90 days after randomisation.
|
|
Overall Survival (OS)
기간: From randomisation to death from any cause, assessed up to 24 months
|
Overall survival is defined as the time from randomisation to death from any cause. Overall survival will be compared between Arm 1 and Arm 2. |
From randomisation to death from any cause, assessed up to 24 months
|
|
Patterns of First Disease Recurrence or Progression
기간: From randomisation to first documented disease recurrence or progression, assessed up to 24 months.
|
The pattern of first disease recurrence or progression will be classified as local progression (in-field recurrence involving the treated primary tumour or nodal disease), regional progression (out-of-field recurrence involving non-treated intrathoracic regional lymph nodes), distant recurrence (recurrence at sites not classified as local or regional, including the non-treated lung), or a combination of these categories. Patterns of first recurrence or progression will be compared between Arm 1 and Arm 2. |
From randomisation to first documented disease recurrence or progression, assessed up to 24 months.
|
|
Incremental Cost per Quality-Adjusted Life Year (QALY) Gained
기간: From randomisation to 24 months
|
Cost-effectiveness will be compared between Arm 1 and Arm 2 using the incremental cost-effectiveness ratio (ICER), calculated as the difference in healthcare costs between treatment arms divided by the difference in quality-adjusted life years (QALYs) gained. |
From randomisation to 24 months
|
기타 결과 측정
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Longitudinal Changes in Circulating Immune Biomarkers and Cell-Free/Circulating Tumour DNA (cfDNA/ctDNA)
기간: Baseline (prior to radiotherapy), Week 2 of radiotherapy, final week of radiotherapy (Week 4 or Week 6-7, depending on treatment arm), 4-6 weeks after radiotherapy, and at disease recurrence or progression, assessed up to 24 months.
|
Longitudinal changes in circulating immune biomarkers, cell-free DNA (cfDNA) and circulating tumour DNA (ctDNA) will be assessed and compared between Arm 1 and Arm 2. Associations between biomarker measures and progression-free survival (PFS), overall survival (OS) and treatment-related adverse events will also be evaluated. |
Baseline (prior to radiotherapy), Week 2 of radiotherapy, final week of radiotherapy (Week 4 or Week 6-7, depending on treatment arm), 4-6 weeks after radiotherapy, and at disease recurrence or progression, assessed up to 24 months.
|
공동 작업자 및 조사자
협력자
협력자
수사관
수사관
- 연구 의자: Joanna J Ludbrook, Calvary Mater Newcastle
- 연구 의자: Shalini Vinod, Liverpool Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- TROG 24.01 MODERN-LUNG
- TOGA 25/003 (기타 식별자: Thoracic Oncology Group of Australasia)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
De-identified individual participant data collected during the trial may be made available to researchers following publication of the final analysis, with no specified end date. Access will be granted to researchers submitting a methodologically sound proposal detailing the research purpose, data requirements and analysis plan. Requests will be subject to approval by the TROG Scientific Committee, in consultation with the Trial Management Committee and, where required, the TROG Secondary Data Analysis Committee. Evidence of ethics approval and an executed data sharing agreement will be required before data transfer.
IPD 공유 기간
De-identified individual participant data will be available following publication of the final trial analysis, with no specified end date.
IPD 공유 액세스 기준
Access may be granted to researchers who submit a methodologically sound proposal detailing the research purpose, specific data requested, data formats, access methods and analysis plan. Requests are subject to approval by the TROG Scientific Committee, in consultation with the MODERN-LUNG Trial Management Committee and, where required, the TROG Secondary Data Analysis Committee. Evidence of ethics approval and an executed data sharing agreement will be required prior to data transfer. Requests can be submitted via https://www.trog.com.au/New-proposals.
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