Clinical trial · Interventional
Hypofraction Radiotherapy for Locally Advanced Non-small Cell Lung Cancer
Hypofraction Radiotherapy Followed by Immune Checkpoint Inhibitors for Locally Advanced Non-small Cell Lung Cancer: A Phase II Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
Definitive concurrent chemoradiotherapy followed by durvalumab (Pacific protocol) has been the standard modality for stage III locally advanced non-small cell lung cancer. In spite of the median overall survival of 47.5 months, there still existed 38.5% and 6.9% patients who finally developed intra-thorax and extra-thorax recurrence respectively in long-term follow-up. The relatively low local control rate has been the bottleneck for further improvement of overall survival. Hypofraction radiotherapy has been validated to be able to increase the local control rate in two prospective trials. Therefore, this trial is designed to explore the safety and primary efficacy of hypofraction radiotherapy followed by immune checkpoint inhibitors for stage III locally advanced non-small cell lung cancer.
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 |
| Radiotherapy Side Effect | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| High-dose hypofractionated radiotherapy | Radiation | — | UNRESOLVED |
| Low-dose hypofractionated radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- High-dose Arm
- description
- Irradiation of 60Gy/15f is administered followed by one-year immunotherapy maintenance.
- interventionNames
- Radiation: High-dose hypofractionated radiotherapy
- type
- EXPERIMENTAL
- label
- Low-dose Arm
- description
- Irradiation of 48Gy/12f is administered followed by one-year immunotherapy maintenance.
- interventionNames
- Radiation: Low-dose hypofractionated radiotherapy
Primary outcomes (4)
- measure
- Rate of radiation-induced pneumonitis (CTCAE V4.0)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * 18-70 years old; * Eastern Cooperative Oncology Group (ECOG) 0-1; * Non-small cell lung cancer including squamous cell carcinoma, adenocarcinoma, adenosquamous carcinoma, large-cell carcinoma; * Wild-type of driven genes; * Stage III (AJCC 8th Edition) confirmed by cranial MRI, chest CT, abdominal ultrasonograph, bone scan or cranial MRI and d Positron Emission Tomography (PET-CT); * Surgically unresectable or deny of surgery; * Signature of inform consent. Exclusion Criteria: * Younger than 18 years old or older than 70 years old; * ECOG\>1; * Small-cell lung cancer and other neuroendocrine carcinoma including typical or atypical carcinoid, large-cell neuroendocrine carcinoma; * Mutant type of driven genes; * Non-stage III (AJCC 8th Edition) confirmed by cranial MRI, chest CT, abdominal ultrasonograph, bone scan or cranial MRI and PET-CT; * Surgically resectable; * No signature of inform consent.
References
Publications (0)
Data not yet available