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

NCT04364776 | Unknown

• 1 other identifier: 20200008978
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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 at least 70 stage III NSCLC patients treated with CT-RT followed by maintenance durvalumab.

Conditions

Lung Cancer; Lung Cancer Stage III

Keywords

durvalumab; radiomics; radiotherapy; immunotherapy

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival

  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 Outcomes (1)

• Overall Survival

  24 months from the end of radiotherapy

Interventions

Durvalumab DRUG

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Inability to sign the informed consent
• Absence of analyzed CT images

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead

Study Sites (1)

Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

Location

Related Publications (1)

• Cabini RF, Brero F, Lancia A, Stelitano C, Oneta O, Ballante E, Puppo E, Mariani M, Ali E, Bartolomeo V, Montesano M, Merizzoli E, Aluia D, Agustoni F, Stella GM, Sun R, Bianchini L, Deutsch E, Figini S, Bortolotto C, Preda L, Lascialfari A, Filippi AR. 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. Insights Imaging. 2022 Mar 7;13(1):38. doi: 10.1186/s13244-022-01171-1.

  PMID: 35254525 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Interventions

durvalumab

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 24, 2020
• First Posted: April 28, 2020
• Study Start: January 15, 2020
• Primary Completion: December 15, 2023
• Study Completion: December 15, 2024
• Last Updated: September 28, 2023

Record last verified: 2023-09

Locations

IT (1)