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

September 26, 2023 updated by: Andrea Riccardo Filippi, IRCCS Policlinico S. Matteo

Blue Sky Radiomics: an Observational Study on Computed Tomography as an Image-based Predictive Marker of Response to Chemoradiation Followed by Durvalumab in Stage III Unresectable Non-small Cell Lung Cancer (NSCLC).

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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.

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.

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.

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Pavia, Italy, 27100
        • Fondazione IRCCS Policlinico San Matteo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Stage III unresectable non-small cell lung cancer patients undergoing chemoradiation followed by durvalumab.

Description

Inclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival
Time Frame: 24 months from the end of radiotherapy
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: 24 months from the end of radiotherapy
Proportion of patients alive at 6, 12, 18 and 24 months, and median overall survival
24 months from the end of radiotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Policlinico S. Matteo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2020

Primary Completion (Estimated)

December 15, 2023

Study Completion (Estimated)

December 15, 2024

Study Registration Dates

First Submitted

April 24, 2020

First Submitted That Met QC Criteria

April 24, 2020

First Posted (Actual)

April 28, 2020

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 26, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20200008978

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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