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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.
Specific aim (one):
To collect and analyze CT scans at diagnosis and after chemoradiation, and assign them to a specific radiomic signature (blind assessment).
Specific aim (two):
- To correlate the radiomics signatures to clinical outcome: the main measure will be progression-free survival at 6 months, the second will be overall survival at 24 months.
This is an observational longitudinal retrospective/prospective study.
Criteria for study entry:
Exclusion criteria:
Treatment:
As per indication, patients should have received a thoracic radiation dose of at least 54 Gy to the primary tumor and lymph nodes; all techniques are allowed. Conventional fractionation or mild hypofractionation is also allowed. All different platinum-based chemotherapy regimens are admitted for the present study in combination with radiotherapy, given either concomitantly or sequentially, according to International Guidelines for combination therapy in locally advanced NSCLC.
Radiomic data extraction: after a pilot harmonization study phase, all CT scans will be analyzed using two different pre-defined signatures. The first one was developed by the Institut Gustave Roussy, Paris, and the second one by Radiomics (Liegi, Belgium). These two signatures have been either linked to response to anti PD1 or to chemoradiation alone.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Durvalumab | Drug | In this observational study, durvalumab will be administered according to current indications (PACIFIC phase III trial). |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival | Proportion of patients without disease progression (local, distant, or both) at 6,12,18 and 24 months, and median Progression-Free survival. | 24 months from the end of radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Proportion of patients alive at 6, 12, 18 and 24 months, and median overall survival | 24 months from the end of radiotherapy |
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Inclusion Criteria:
Exclusion Criteria:
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Stage III unresectable non-small cell lung cancer patients undergoing chemoradiation followed by durvalumab.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione IRCCS Policlinico San Matteo | Pavia | 27100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35254525 | Derived | Cabini 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. |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000613593 | durvalumab |
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |