Radiomic Signature as Predictive Marker of Response to Chemoradiation and Durvalumab in Stage III NSCLC.

Sponsor
Fondazione IRCCS Policlinico San Matteo di Pavia
Study ID
NCT04364776
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — DRUG
    In this observational study, durvalumab will be administered according to current indications (PACIFIC phase III trial).

Study Details

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.

Key Dates

Start date
Jan 15, 2020
Status verified
Sep 2023
Primary completion
Dec 15, 2023
Completion
Dec 15, 2024

Study Design

Enrollment
100 participants (actual)

Primary Outcome Measure

Progression-Free Survival [ Time Frame: 24 months from the end of radiotherapy ]

Related Studies