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
Updated on 25 January 2021
cancer
lung cancer
durvalumab
stage iii non-small cell lung cancer
lung carcinoma

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 IdentifierNCT04364776
SponsorIRCCS Policlinico S. Matteo
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 80 yrs?
Gender: Male or Female
Do you have any of these conditions: Lung Neoplasm or Bronchial Neoplasm or Pulmonary Disease or Lung Cancer or Lung Cancer Stage III or Lung Disease?
Do you have any of these conditions: carcinoma lung or Lung Cancer Stage III or Lung Disease or Bronchial Neoplasm or Lung Cancer or lung carcinoma or Pulmonary Disease or Lung Neoplasm?
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
Clear my responses

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