Stage III NSCLCMODERN-LUNGNCT07922135
Moderately Hypofractionated Versus Conventional Chemoradiotherapy With Consolidation Immunotherapy in Patients With Unresectable, Non-Targetable Stage III Non Small Cell Lung Cancer (NSCLC)
A study testing Moderately Hypofractionated Radiotherapy and Conventionally Fractionated Radiotherapy in people with Stage III NSCLC, run by Trans Tasman Radiation Oncology Group.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage III NSCLC
- What is being tested?
- Moderately Hypofractionated Radiotherapy and Conventionally Fractionated Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 30 Mar 2027to 30 Mar 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Stage III NSCLC
- Being tested
- Moderately Hypofractionated Radiotherapy, Conventionally Fractionated Radiotherapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderately Hypofractionated RadiotherapyRadiation
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).
Conventionally Fractionated RadiotherapyRadiation
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).
| Study group | Role | What they receive |
|---|---|---|
| ARM 1 - Moderately Hypofractionated Chemoradiotherapy (4 weeks) | Experimental | 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). Receives: Radiation: Moderately Hypofractionated Radiotherapy |
| ARM 2 - Standard Chemoradiotherapy (6-6.5weeks) | Active comparator | 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). Receives: Radiation: Conventionally Fractionated Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Win Ratio Based on a Hierarchical Composite Endpoint
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.
Measured: 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.
Secondary outcomes (7)
Progression free survival (PFS)
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.
Measured: 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
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.
Measured: From treatment commencement to 90 days after treatment commencement.
Number of Healthcare Contact Days
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.
Measured: From randomisation to 90 days after randomisation.
Change From Baseline in Quality of Life Scores at 90 Days
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.
Measured: Baseline to 90 days after randomisation.
Overall Survival (OS)
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.
Measured: From randomisation to death from any cause, assessed up to 24 months
Patterns of First Disease Recurrence or Progression
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.
Measured: From randomisation to first documented disease recurrence or progression, assessed up to 24 months.
Incremental Cost per Quality-Adjusted Life Year (QALY) Gained
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.
Measured: From randomisation to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start30 Mar 2027 (estimated)
- Primary completion30 Mar 2032 (estimated)
- Study completion30 Mar 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage III NSCLCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Trans Tasman Radiation Oncology Group
- Sponsor type
- University, hospital or other
- Collaborators
- Thoracic Oncology Group Australasia (TOGA)
- Responsible party
- Sponsor
- Investigators
- Joanna J Ludbrook, Study chair, Calvary Mater NewcastleShalini Vinod, Study chair, Liverpool Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07922135
- Sponsor's protocol ID
- TROG 24.01 MODERN-LUNG
- Other IDs
- TOGA 25/003
- Acronym
- MODERN-LUNG
- Status last verified
- Nov 2026
- First submitted
- 25 Oct 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Moderately Hypofractionated Versus Conventional Chemoradiotherapy With Consolidation Immunotherapy, in Patients With Unresectable, Non-Targetable Stage III NSCLC: A Phase III Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07922135
- Acronym / sponsor ID
- MODERN-LUNG / TROG 24.01 MODERN-LUNG
- Conditions
- Stage III NSCLC
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Trans Tasman Radiation Oncology GroupUniversity, hospital or other
- Collaborators
- Thoracic Oncology Group Australasia (TOGA)
- Study start
- 30 Mar 2027 (estimated)
- Primary completion
- 30 Mar 2032 (estimated)
- Study completion
- 30 Mar 2032 (estimated)
- First posted
- 6 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARM 1 - Moderately Hypofractionated Chemoradiotherapy (4 weeks) | Experimental | Radiation: Moderately Hypofractionated RadiotherapyParticipants 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). |
| ARM 2 - Standard Chemoradiotherapy (6-6.5weeks) | Active comparator | Radiation: Conventionally Fractionated RadiotherapyParticipants 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (10 listed)
- Targetable driver mutation
- Contraindication to curative dose radiotherapy
- Contraindication to chemotherapy
- Contraindication to immunotherapy
- Planned for induction or consolidation chemotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moderately Hypofractionated RadiotherapyParticipants 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). | Radiation | ARM 1 - Moderately Hypofractionated Chemoradiotherapy (4 weeks) |
| Conventionally Fractionated RadiotherapyParticipants 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). | Radiation | ARM 2 - Standard Chemoradiotherapy (6-6.5weeks) |
Primary outcome
Win Ratio Based on a Hierarchical Composite Endpoint
Time frame: 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.
7 secondary outcomes
Progression free survival (PFS)
Time frame: 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
Time frame: From treatment commencement to 90 days after treatment commencement.
Number of Healthcare Contact Days
Time frame: From randomisation to 90 days after randomisation.
Change From Baseline in Quality of Life Scores at 90 Days
Time frame: Baseline to 90 days after randomisation.
Overall Survival (OS)
Time frame: From randomisation to death from any cause, assessed up to 24 months
Patterns of First Disease Recurrence or Progression
Time frame: From randomisation to first documented disease recurrence or progression, assessed up to 24 months.
Incremental Cost per Quality-Adjusted Life Year (QALY) Gained
Time frame: From randomisation to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joanna J Ludbrook study chair
Calvary Mater Newcastle
Shalini Vinod study chair
Liverpool Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Moderately Hypofractionated Radiotherapy and Conventionally Fractionated Radiotherapy in people with Stage III NSCLC, run by Trans Tasman Radiation Oncology Group.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Courtney Wheeler (+61 2 40143911, MODERN-LUNG@trog.com.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Win Ratio Based on a Hierarchical Composite Endpoint (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.