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NCT04364776

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

Status unknown Last updated 28 September 2023
What this trial tests

trial testing Durvalumab in Lung Cancer in 100 participants. Status unknown.

Timeline
15 January 2020
Primary endpoint
15 December 2023
15 December 2024

Quick facts

Lead sponsorFondazione IRCCS Policlinico San Matteo di Pavia
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment100
Start date15 January 2020
Primary completion15 December 2023
Estimated completion15 December 2024
Sites1 location across Italy

Drugs / interventions tested

Conditions studied

Sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Who can join

Adults 18 to 80, any sex, with Lung Cancer or Lung Cancer Stage III. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Radiotherapy combined with immunotherapy: the dawn of cancer treatment.
    Zhang Z, Liu X, Chen D, Yu J. · · 2022 · cited 463× · PMID 35906199 · DOI 10.1038/s41392-022-01102-y
  2. Radiomics as a New Frontier of Imaging for Cancer Prognosis: A Narrative Review.
    Reginelli A, Nardone V, Giacobbe G, Belfiore MP, et al · · 2021 · cited 39× · PMID 34679494 · DOI 10.3390/diagnostics11101796
  3. The Role of Radiomics in the Era of Immune Checkpoint Inhibitors: A New Protagonist in the Jungle of Response Criteria.
    Castello A, Castellani M, Florimonte L, Urso L, et al · · 2022 · cited 20× · PMID 35330068 · DOI 10.3390/jcm11061740
  4. 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.
    Cabini RF, Brero F, Lancia A, Stelitano C, et al · · 2022 · cited 7× · PMID 35254525 · DOI 10.1186/s13244-022-01171-1
  5. Radiomics-guided checkpoint inhibitor immunotherapy for precision medicine in cancer: A review for clinicians.
    Zhou H, Luo Q, Wu W, Li N, et al · · 2023 · cited 6× · PMID 36936913 · DOI 10.3389/fimmu.2023.1088874
  6. Immunotherapy combined with radiotherapy for advanced non-small cell lung cancer: Current status and challenge (Review).
    Li Q, Cai YQ, Shao LH, Qi YX, et al · · 2025 · PMID 40799300 · DOI 10.3892/ol.2025.15215

Verify or expand the search:

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Trials by the same sponsor.

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