Clinical trial · Interventional
Combining ICI With SBRT or HypoFrx-RT for ES NSCLC
Combining an Immune Checkpoint Inhibitor With SBRT or Hypo-fractionated RT in the Treatment of Stage I-III NSCLC: an Exploratory Study on Radiation Dose and Treatment Efficacy.
- 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 will explore the best dose of radiation to be used when treating stage I-III non-small cell lung cancer (NSCLC) with stereotactic body radiation therapy (SBRT) or hypo-fractionated radiotherapy (HypoFrx-RT) that is delivered in combination with an immune checkpoint inhibitor. Treatments with SBRT or HypoFrx-RT for locally confined NSCLC show positive response which may be further augmented when they are combined with an immune checkpoint inhibitor. Currently, it is not understood what radiation dose is most suitable for such combined treatments and their clinical efficacy in the treatment of early stage (ES) NSCLC. Therefore, this study can help researchers gain insight into what a safe and effective SBRT or HypoFrx-RT dose will be when such radiotherapeutic approaches are combined with concurrent and adjuvant administration of an immune checkpoint inhibitor in the treatment of ES NSCLC.
Conditions
Conditions (5)
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 Carcinoma | Non-Small Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Non-small Cell Lung Cancer Stage I | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Non-small Cell Lung Cancer Stage II | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Non-small Cell Lung Cancer Stage III | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Durvalumab | Drug | Durvalumab | ALIAS |
| Hypofractionated radiotherapy | Radiation | — | UNRESOLVED |
| Stereotactic body radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cohort A
- description
- SBRT to be delivered with concurrent and adjuvant anti-PD-(L)1 immune checkpoint inhibitor.
- interventionNames
- Radiation: Stereotactic body radiotherapy
- Drug: Durvalumab
- type
- EXPERIMENTAL
- label
- Cohort B
- description
- Hypo-fractionated radiotherapy to be delivered with concurrent and adjuvant anti-PD-(L)1 immune checkpoint inhibitor.
- interventionNames
- Radiation: Hypofractionated radiotherapy
- Drug: Durvalumab
Primary outcomes (3)
- measure
- Maximum tolerated dose (MTD)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Key Inclusion Criteria 1. Informed Consent 2. Stage I-III NSCLC per AJCC 8th. ed. 3. Tumor PD-L1 expression ≥1% preferred 4. Tumor sample submission 5. Tumor staging prior to registration 6. Age ≥ 18 years 7. WHO/ECOG PS of 0, 1, or 2 8. Life expectancy ≥12 weeks 9. Adequate organ or bone marrow function 10. Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Exclusion Criteria: Key Exclusion Criteria 1. Mixed small cell and non-small cell lung cancer histology 2. Definitive clinical or radiologic evidence of metastatic disease 3. Patients who received systemic therapy for the current cancer prior to enrollment 4. Thoracic radiotherapy within 5 years with exceptions 5. Major surgery within 28 days prior to enrollment with exception 6. Prior exposure to any anti-PD-1 or anti-PD-L1 antibody 7. History of another primary malignancy with exceptions 8. History of idiopathic pulmonary fibrosis, any pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on chest PET/CT or CT scan 9. Active or prior documented autoimmune disease with exceptions 10. History of primary immunodeficiency 11. History of allogenic organ or tissue transplantation
References
Publications (0)
Data not yet available