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.
Обзор исследования
Статус
Условия
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Courtney Wheeler
- Номер телефона: +61 2 40143911
- Электронная почта: MODERN-LUNG@trog.com.au
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: 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). |
|
Активный компаратор: 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). |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Win Ratio Based on a Hierarchical Composite Endpoint
Временное ограничение: 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.
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Progression free survival (PFS)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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.
|
|
Change From Baseline in Quality of Life Scores at 90 Days
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
|
Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Longitudinal Changes in Circulating Immune Biomarkers and Cell-Free/Circulating Tumour DNA (cfDNA/ctDNA)
Временное ограничение: 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.
|
Соавторы и исследователи
Следователи
- Учебный стул: Joanna J Ludbrook, Calvary Mater Newcastle
- Учебный стул: Shalini Vinod, Liverpool Hospital
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- TROG 24.01 MODERN-LUNG
- TOGA 25/003 (Другой идентификатор: Thoracic Oncology Group of Australasia)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
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.
Сроки обмена IPD
De-identified individual participant data will be available following publication of the final trial analysis, with no specified end date.
Критерии совместного доступа к IPD
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.
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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