Clinical trial · Observational
Radiomic Signature as Predictive Marker of Response to Chemoradiation and Durvalumab in Stage III NSCLC.
Blue Sky Radiomics: an Observational Study on Computed Tomography as an Image-based Predictive Marker of Response to Chemoradiation Followed by Durvalumab in Stage III Unresectable Non-small Cell Lung Cancer (NSCLC).
- 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)
The introduction of maintenance immunotherapy with the anti PD-L1 inhibitor durvalumab opened a new therapeutic window for stage III NSCLC patients who achieve at least stable disease after chemo-radiation, as shown by the randomized phase 3 PACIFIC study. However, still half of the patients do progress at 12 months (up to 70% at 18 months). In this study, the investigators aim to test a non-invasive image-based approach, namely a "radiomics" platform, as a tool to define a higher or lower likelihood of response to chemo-radiation and durvalumab. For this purpose, we will retrospectively and prospectively collect and analyze a cohort of at least 70 stage III NSCLC patients treated with CT-RT followed by maintenance durvalumab.
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 |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Lung Cancer Stage III | Malignant Lung Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Durvalumab | Drug | Durvalumab | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Progression-Free Survival
- timeFrame
- 24 months from the end of radiotherapy
- description
- Proportion of patients without disease progression (local, distant, or both) at 6,12,18 and 24 months, and median Progression-Free survival.
Secondary outcomes (1)
- measure
- Overall Survival
- timeFrame
- 24 months from the end of radiotherapy
- description
- Proportion of patients alive at 6, 12, 18 and 24 months, and median overall survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC) * Age 18-80 * Stage IIIA-IIIB-IIIC disease judged to be unresectable by a multidisciplinary team including pulmonologists, thoracic surgeons, medical and radiation oncologists. * Signed informed consent Exclusion Criteria: * Inability to sign the informed consent * Absence of analyzed CT images
References
Publications (1)
- DERIVEDCabini RF, Brero F, Lancia A, Stelitano C, Oneta O, Ballante E, Puppo E, Mariani M, Ali E, Bartolomeo V, Montesano M, Merizzoli E, Aluia D, Agustoni F, Stella GM, Sun R, Bianchini L, Deutsch E, Figini S, Bortolotto C, Preda L, Lascialfari A, Filippi AR. Preliminary report on harmonization of features extraction process using the ComBat tool in the multi-center "Blue Sky Radiomics" study on stage III unresectable NSCLC. Insights Imaging. 2022 Mar 7;13(1):38. doi: 10.1186/s13244-022-01171-1. PMID 35254525