A Spanish Medical Record Review of Clinical Characteristics and Outcomes in Non-small Cell Lung Cancer Participants With EGFR Exon 20 Insertion

NCT05419700 | Completed

• 1 other identifier: TAK-788-5009
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 15

Brief Summary

The main aim is to evaluate sociodemographic and clinical characteristics of advanced Non-Small Cell Lung Cancer (NSCLC) in adults participants with epidermal growth factor receptor (EGFR) exon 20 insertions mutations during the 5 years before data extraction date (from 1-Jan-2017 to 1-Jan-2022). Participants will not receive any drug. This study will only collect the data from the medical records via chart review.

Conditions

Non-small Cell Lung Cancer (NSCLC)

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Based on Type of EGFR Mutation

  Percentage of participants will be reported based on type of EGFR mutation and its variant: EGFR exon 20 insertion or compound mutations.

  From the treatment start date till the data extraction date (1-Jan-2017 to 1-Jan-2022)

Secondary Outcomes (10)

• Overall Response Rate (ORR)

  From the treatment start date till the data extraction date (1-Jan-2017 to 1-Jan-2022)

• Progression-free Survival (PFS)

  From the treatment start date till the data extraction date (1-Jan-2017 to 1-Jan-2022)

• Disease Control Rate (DCR)

  From the treatment start date till the data extraction date (1-Jan-2017 to 1-Jan-2022)

• Time-to-treatment Failure (TTF)

  From the treatment start date till the data extraction date (1-Jan-2017 to 1-Jan-2022)

• Overall Survival (OS)

  From the treatment start date till the data extraction date (1-Jan-2017 to 1-Jan-2022)

Study Arms (1)

Participants with Advanced NSCLC With EGFR Exon 20 Insertions Mutations

All participants diagnosed with advanced NSCLC with Epidermal growth factor receptor EGFR exon 20 insertion mutations will be enrolled in this study. All study data will be collected retrospectively from participants medical records via medical chart review.

Eligibility Criteria

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

Study Population

Adult participants with advanced NSCLC with EGFR exon 20 insertion and who received treatment during the last 5 years at participating sites will be included in this study.

You may qualify if:

• Participants with a pathologically and/or cytologically confirmed diagnosis of advanced stage NSCLC (International Classification of Disease, 10th revision \[ICD-10\] C34.x), either primary, advanced or after relapse of initial non-metastatic disease, evaluated and treated during the last five years prior data extraction date from 1-Jan-2017 to 1-Jan-2022.
• Participants with detection of an EGFR exon 20 insertion mutation, at any point.
• Has documentation available for at least 2 visits since the initiation of the last treatment within the last five years (1-January-2017 to 1-January-2022).

Sponsors & Collaborators

• Takeda: lead

Study Sites (15)

Hospital Universitario Reina Sofia

Córdoba, Andalusia, 14004, Spain

Location

Hospital Universitario Virgen de la Victoria

Málaga, Andalusia, 29010, Spain

Location

Hospital Universitario Virgen del Rocio

Seville, Andalusia, 41013, Spain

Location

ICO Badalona. Hospital Universitario Germans Trias i Pujol

Badalona, Catalonia, 8916, Spain

Location

Hospital Clinicde Barcelona

Barcelona, Catalonia, 08036, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, Catalonia, 08041, Spain

Location

ICO Girona. Hospital Universitario Dr. Josep Trueta

Girona, Catalonia, 17007, Spain

Location

Complejo Hospitalario Universitario A Coruna (CHUAC)

A Coruña, Galicia, 15006, Spain

Location

Complejo Hospitalario Universitario de Santiago (CHUS)

Santiago de Compostela, Galicia, 15706, Spain

Location

Hospital Universitario Ramon y Cajal

Madrid, Madrid, 28034, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, Madrid, 28041, Spain

Location

Hospital Universitario Puerta de Hierro

Madrid, Madrid, 28222, Spain

Location

Hospital Universitario de Navarra (HUN)

Pamplona, Navarre, 31008, Spain

Location

Hospital General Universitario de Alicante

Alicante, Valencia, 03010, Spain

Location

Hospital Universitari i Politecnic la Fe

Valencia, Valencia, 46026, Spain

Location

Related Links

• To obtain more information on the study, click here/on this link.

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: June 10, 2022
• First Posted: June 15, 2022
• Study Start: August 5, 2022
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: September 6, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

ES (15)