Thyroid Dysfunction and Nivolumab Reponse in NSCLC

NCT04470440 | Completed

• 1 other identifier: THYRONIVO (29BRC19.0228)
• Study Type: observational
• Target: 134
• Locations: 1 country
• Sites: 1

Brief Summary

This is an observational, retrospective and monocentric study, conducted at the university Hospital of Brest The primary objective is to assess the association between the occurrence of thyroid dysfunction in patients treated with Nivolumab® for a non-small cell lung cancer and prognosis and therapeutic response The second objective is to assess prognosis and therapeutic response according to severity and subtype of thyroid dysfunction

Conditions

Non Small Cell Lung Cancer Metastatic; Treatment Adverse Effect; Thyroid Dysfunction; Immune Checkpoint Inhibitor; Prognosis

Outcome Measures

Primary Outcomes (1)

• overall survival

  OS was defined as the time between the introduction of Nivolumab® and death

  up to 48 months

Secondary Outcomes (3)

• objective response rate (ORR)

  up to 48 months

• disease control rate (DCR)

  up to 48 months

• Progression-free survival

  up to 48 months

Eligibility Criteria

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

Study Population

patients treated with Nivolumab® for a non-small cell lung cancer as a second line

You may qualify if:

• patients at least 18 years old and had histologically confirmed locally advanced stage (IIIB) or metastatic (IV) non-small cell lung cancer with disease progression;
• treated with Nivolumab® as second or more therapeutic line
• in the oncologic department university hospital of Brest

You may not qualify if:

• patients whose primary tumor was not from bronchopulmonary origin
• patients with a history of total thyroidectomy and/or having previously treated with levothyroxine and/or having a thyroid dysfunction previously to the introduction of Nivolumab®
• patients not having any thyroid monitoring during Nivolumab® treatment, and those for which data were missing
• patients who expressed their opposition to participate in the study

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

CHRU de Brest

Brest, 2909, France

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: July 14, 2020
• Study Start: October 22, 2019
• Primary Completion: November 5, 2019
• Study Completion: November 5, 2019
• Last Updated: July 14, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning trois month and ending five year following the end of the study
• Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

Locations

FR (1)