Clinical trial · Interventional
Post-operative Radiotherapy After Neodjuvant Chemo-immunotherapy and Surgery in Stage III NSCLC
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Stage III Lung Cancer | Malignant Lung Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Post-operative radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Post-operative radiotherapy
- description
- Mediastinal PORT (40 Gy in 15 fractions) within 24 weeks from thoracic surgery
- interventionNames
- Radiation: Post-operative radiotherapy
- type
- NO_INTERVENTION
- label
- No post-operative radiotherapy
- description
- No post-operative radiotherapy (PORT)
Primary outcomes (1)
- measure
- Disease-free Survival
- timeFrame
- 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)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Participants must be ≥ 18 years old 2. Ability to provide written informed consent 3. ECOG performance status 0-2 4. Histologically confirmed NSCLC 5. Absence of actionable driver mutation (EGFR/ALK/ROS) 6. Complete preoperative imaging staging, including: FDG-PET and brain imaging to exclude distant metastases will be mandatory. 7. Baseline clinical or post-operative pathological stage III including specifically stage T1-4N2-3 8. Completion of 2-4 cycles of neoadjuvant chemo-IO, regardless of the specific immunotherapy and chemotherapy used. 9. Status post-complete (R0) surgical resection with mediastinal lymph node dissection. 10. Residual nodal disease on final pathology specimen (i.e. absence of pathological complete response). 11. Postoperative lung function examination: FEV1 \> 1 L (or greater than 35% expected value) Exclusion Criteria: 1. Pregnant individuals 2. Previous chest radiotherapy 3. \>24 weeks after thoracic surgery 4. History of other non-cutaneous neoplasms within the last 24 months 5. Active grade ≥ 2 pneumonitis. 6. Presence of interstitial lung disease 7. Recurrence or metastasis occurred 8. Medical conditions that hinders the safe administration of radiotherapy or follow-up.
References
Publications (0)
Data not yet available