Radiomic Signature as Predictive Marker of Response to Chemoradiation and Durvalumab in Stage III NSCLC.
-
- STATUS
- Recruiting
-
- End date
- Apr 15, 2024
-
- participants needed
- 70
-
- sponsor
- IRCCS Policlinico S. Matteo
Summary
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 70 stage III NSCLC patients treated with CT-RT followed by maintenance durvalumab.
A secondary analysis will assess the tumor mutational burden (TMB) and its potential correlation with either radiomic features and/or response.
Description
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.
- As an exploratory study, to investigate for the tumor mutational burden (TMB, on biopsy tissue baseline) and its possible correlation with response/progression.
This is an observational longitudinal retrospective/prospective study.
Criteria for study entry:
- Histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC)
- Age 18-80
- Stage IIIA-C 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
- 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.
Details
| Condition | Pulmonary Disease, Lung Neoplasm, Bronchial Neoplasm, Lung Cancer, Lung Cancer Stage III, Lung Disease, carcinoma lung, lung carcinoma |
|---|---|
| Treatment | durvalumab |
| Clinical Study Identifier | NCT04364776 |
| Sponsor | IRCCS Policlinico S. Matteo |
| Last Modified on | 25 January 2021 |
How to participate?
,
You have contacted , on
Your message has been sent to the study team at ,
What happens next?
- You can expect the study team to contact you via email or phone in the next few days.
- Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
Learn moreSimilar trials to consider
Browse trials for
Not finding what you're looking for?
Sign up as a volunteer to stay informed
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.
Sign up as volunteer