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New treatment option for Non Small Cell Lung Cancer
Official title Post-operative Radiotherapy After Neodjuvant Chemo-immunotherapy and Surgery in Stage III NSCLC
ClinicalTrials.gov ID: NCT06878274
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 7 years
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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)
You likely can't join if
- 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
See the full eligibility 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)
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Montreal, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 7 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Montreal, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.