Non Small Cell Lung CancerPhase 2RESCUENCT06878274
Post-operative Radiotherapy After Neodjuvant Chemo-immunotherapy and Surgery in Stage III NSCLC
A Phase 2 study testing Post-operative radiotherapy in people with Non Small Cell Lung Cancer and Stage III Lung Cancer, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
This study investigates whether postoperative radiotherapy (PORT) improves outcomes for patients with stage III non-small cell lung cancer (NSCLC) who have residual disease after neoadjuvant chemo-immunotherapy and surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer, Stage III Lung Cancer
- What is being tested?
- Post-operative radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteCanada
- Study dates
- 29 Jan 2026to Feb 2032
- Phase
- Phase 2
- 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
- Participants must be ≥ 18 years old
- Ability to provide written informed consent
- ECOG performance status 0-2
- Histologically confirmed NSCLC
- Absence of actionable driver mutation (EGFR/ALK/ROS)
- Complete preoperative imaging staging, including: FDG-PET and brain imaging to exclude distant metastases will be mandatory.
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- Baseline clinical or post-operative pathological stage III including specifically stage T1-4N2-3
- Completion of 2-4 cycles of neoadjuvant chemo-IO, regardless of the specific immunotherapy and chemotherapy used.
- Status post-complete (R0) surgical resection with mediastinal lymph node dissection.
- Residual nodal disease on final pathology specimen (i.e. absence of pathological complete response).
- Postoperative lung function examination: FEV1 > 1 L (or greater than 35% expected value)
Who cannot join
- Pregnant individuals
- Previous chest radiotherapy
- >24 weeks after thoracic surgery
- History of other non-cutaneous neoplasms within the last 24 months
- Active grade ≥ 2 pneumonitis.
- Presence of interstitial lung disease
- Recurrence or metastasis occurred
- Medical conditions that hinders the safe administration of radiotherapy or follow-up.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H4C 3N4
Houda Bahig, MD PhD, 514-890-8254, houda.bahig.med@ssss.gouv.qc.ca
Eva-Sabrina Nkurunziza
About this study
Official title: Radiotherapy to Optimize Event-free Survival Following Chemo-Immunotherapy and Surgery in Upper Stage III NSCLC With Evidence of Pathological Residual Disease (RESCUE): Phase II Trial
This study investigates whether postoperative radiotherapy (PORT) improves outcomes for patients with stage III non-small cell lung cancer (NSCLC) who have residual disease after neoadjuvant chemo-immunotherapy and surgery. The primary objective is to compare event-free survival (EFS) between patients receiving PORT targeting involved lymph node regions and those without PORT. Secondary and tertiary endpoints include overall survival, locoregional and distant control, toxicity, and quality of life. The phase II randomized trial will enroll 118 patients, stratifying by adjuvant immunotherapy use, with follow-up extending up to 5 years. Statistical analysis aims to detect a 15% improvement in 2-year EFS, with a total study duration of 7 years.
- Conditions
- Non Small Cell Lung Cancer, Stage III Lung Cancer
- Being tested
- Post-operative radiotherapy
- Keywords
- Post operative radiotherapy, lung cancer, non small cell lung cancer, stage III lung cancer, neoadjuvant immunotherapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post-operative radiotherapyRadiation
Mediastinal post-operative radiotherapy to a dose of 40 Gy in 15 fractions
| Study group | Role | What they receive |
|---|---|---|
| Post-operative radiotherapy | Experimental | Mediastinal PORT (40 Gy in 15 fractions) within 24 weeks from thoracic surgery Receives: Radiation: Post-operative radiotherapy |
| No post-operative radiotherapy | No intervention | No post-operative radiotherapy (PORT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free Survival
Measured: Defined as the time from random assignment to loco-regional or distant recurrence, or death from any cause, assessed up to 60 months.
Secondary outcomes (4)
Overall Survival
Measured: Time from random assignment to death from any cause, assessed up to 60 months.
Grade 3 Toxicity
Measured: Classified as early (within the first 3 months) or late (after 3 months), assessed up to 60 months.
Locoregional control
Measured: Time from random assignment to locoregional recurrence, proven radiologically and/or pathologically, assessed up to 60 months.
Distant metastasis free survival
Measured: Time from random assignment to distant recurrence, proven radiologically and/or pathologically, or death from any cause, assessed up to 60 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start29 Jan 2026
- Primary completionFeb 2030 (estimated)
- Study completionFeb 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06878274
- Sponsor's protocol ID
- RESCUE
- Acronym
- RESCUE
- Status last verified
- Aug 2026
- First submitted
- 4 Dec 2024
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD includes anonymized individual participant data collected throughout the course of the study and may include the analyzable data set.
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiotherapy to Optimize Event-free Survival Following Chemo-Immunotherapy and Surgery in Upper Stage III NSCLC With Evidence of Pathological Residual Disease (RESCUE): Phase II Trial
- ClinicalTrials.gov ID
- NCT06878274
- Acronym / sponsor ID
- RESCUE / RESCUE
- Conditions
- Non Small Cell Lung Cancer, Stage III Lung Cancer
- Keywords
- Post operative radiotherapy, lung cancer, non small cell lung cancer, stage III lung cancer, neoadjuvant immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- 29 Jan 2026 (actual)
- Primary completion
- Feb 2030 (estimated)
- Study completion
- Feb 2032 (estimated)
- First posted
- 14 Mar 2025 (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 study investigates whether postoperative radiotherapy (PORT) improves outcomes for patients with stage III non-small cell lung cancer (NSCLC) who have residual disease after neoadjuvant chemo-immunotherapy and surgery. The primary objective is to compare event-free survival (EFS) between patients receiving PORT targeting involved lymph node regions and those without PORT. Secondary and tertiary endpoints include overall survival, locoregional and distant control, toxicity, and quality of life. The phase II randomized trial will enroll 118 patients, stratifying by adjuvant immunotherapy use, with follow-up extending up to 5 years. Statistical analysis aims to detect a 15% improvement in 2-year EFS, with a total study duration of 7 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Post-operative radiotherapy | Experimental | Radiation: Post-operative radiotherapyMediastinal PORT (40 Gy in 15 fractions) within 24 weeks from thoracic surgery |
| No post-operative radiotherapy | No intervention | –No post-operative radiotherapy (PORT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Participants must be ≥ 18 years old
- Ability to provide written informed consent
- ECOG performance status 0-2
- Histologically confirmed NSCLC
- Absence of actionable driver mutation (EGFR/ALK/ROS)
Key exclusion criteria (8 listed)
- Pregnant individuals
- Previous chest radiotherapy
- >24 weeks after thoracic surgery
- History of other non-cutaneous neoplasms within the last 24 months
- Active grade ≥ 2 pneumonitis.
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 |
|---|---|---|
| Post-operative radiotherapyMediastinal post-operative radiotherapy to a dose of 40 Gy in 15 fractions | Radiation | Post-operative radiotherapy |
Primary outcome
Disease-free Survival
Time frame: Defined as the time from random assignment to loco-regional or distant recurrence, or death from any cause, assessed up to 60 months.
4 secondary outcomes
Overall Survival
Time frame: Time from random assignment to death from any cause, assessed up to 60 months.
Grade 3 Toxicity
Time frame: Classified as early (within the first 3 months) or late (after 3 months), assessed up to 60 months.
Locoregional control
Time frame: Time from random assignment to locoregional recurrence, proven radiologically and/or pathologically, assessed up to 60 months.
Distant metastasis free survival
Time frame: Time from random assignment to distant recurrence, proven radiologically and/or pathologically, or death from any cause, assessed up to 60 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 14 Aug 2026.
- Individual participant dataSharing planned: Yes. IPD includes anonymized individual participant data collected throughout the course of the study and may include the analyzable data set.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Post-operative radiotherapy in people with Non Small Cell Lung Cancer and Stage III Lung Cancer, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
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 11 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Houda Bahig, MD PhD (514-890-8254, houda.bahig.med@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free Survival (time frame: Defined as the time from random assignment to loco-regional or distant recurrence, or death from any cause, assessed up to 60 months.). 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 14 Aug 2026.