Post-operative Radiotherapy After Neodjuvant Chemo-immuno... | NCT06878274

Studies
Post-operative Radiotherapy After Neodjuvant Chemo-immunotherapy and Surgery in Stage III NSCLC

NCT06878274

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Status

Recruiting

Last Update Posted

Feb 10, 2026Actual

Enrollment

118Estimated

Phase

Phase 2

Conditions

Non Small Cell Lung Cancer
Stage III Lung Cancer

Interventions

Post-operative radiotherapy

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 29, 2026Actual

Primary Completion Date

Feb 2030Estimated

Completion Date

Feb 2032Estimated

First Submitted Date

Dec 4, 2024

First Submission Date that Met QC Criteria

Mar 11, 2025

First Posted Date

Mar 14, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 7, 2026

Last Update Posted Date

Feb 10, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

118Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Post-operative radiotherapy	Experimental	Mediastinal PORT (40 Gy in 15 fractions) within 24 weeks from thoracic surgery	Radiation: Post-operative radiotherapy
No post-operative radiotherapy	No Intervention	No post-operative radiotherapy (PORT)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Post-operative radiotherapy	Radiation	Mediastinal post-operative radiotherapy to a dose of 40 Gy in 15 fractions	Post-operative radiotherapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Disease-free Survival		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

Measure	Description	Time Frame
Overall Survival		Time from random assignment to death from any cause, assessed up to 60 months.
Grade 3 Toxicity		Classified as early (within the first 3 months) or late (after 3 months), assessed up to 60 months.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.
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)

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Houda Bahig, MD PhD	Contact	514-890-8254		houda.bahig.med@ssss.gouv.qc.ca
Mom Phat	Contact	514-890-8254		mom.phat.chum@ssss.gouv.qc.ca

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Hospitalier de l'Université de Montréal	Recruiting	Montreal	Quebec	H4C 3N4	Canada

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

IPD includes anonymized individual participant data collected throughout the course of the study and may include the analyzable data set.

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)

Time Frame

study completion date, up to 60 months.

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002289	Carcinoma, Non-Small-Cell Lung
D008175	Lung Neoplasms

Ancestor Terms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided