Clinical trial NCT05419700: A Spanish Medical Record Review of Clinical Characteristics and Outcomes in Non-small Cell Lung Cancer Participants With EGFR Exon 20 Insertion
Official title: Patient Characteristics, Treatment Patterns and Outcomes of Advanced Non-small Cell Lung Cancer Patients With EGFR Exon 20 Insertion Mutations: A Non-interventional Retrospective Medical Chart Review in Spain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-small Cell Lung Cancer (NSCLC)
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2022-06-15
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Detailed description: This is an observational, non-interventional, retrospective study in participants with NSCLC with EGFR exon 20 insertions mutations. This study will assess the sociodemographic and clinical characteristics of advanced NSCLC participants.

The study will enroll approximately 60 participants. Participants who were evaluated and treated at the participating sites between 01 January 2017 and 30 September 2021 will be included. The data will be collected from the medical record of participants via medical chart review. All the participants will be assigned to a single observational cohort:

• Participants With Advanced NSCLC with EGFR Exon 20 Insertions Mutations

This multi-center trial will be conducted in Spain. The overall duration of the study will be approximately 27 months.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. Participants with detection of an EGFR exon 20 insertion mutation, at any point.
3. 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).

Exclusion Criteria:

1. Participants do not meet any of the inclusion criteria.

Primary outcomes:
measure: Percentage of Participants Based on Type of EGFR Mutation
timeFrame: From the treatment start date till the data extraction date (1-Jan-2017 to 1-Jan-2022)
Secondary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: From the treatment start date till the data extraction date (1-Jan-2017 to 1-Jan-2022)
measure: Progression-free Survival (PFS)
timeFrame: From the treatment start date till the data extraction date (1-Jan-2017 to 1-Jan-2022)
measure: Disease Control Rate (DCR)
timeFrame: From the treatment start date till the data extraction date (1-Jan-2017 to 1-Jan-2022)
measure: Time-to-treatment Failure (TTF)
timeFrame: From the treatment start date till the data extraction date (1-Jan-2017 to 1-Jan-2022)
measure: Overall Survival (OS)
timeFrame: From the treatment start date till the data extraction date (1-Jan-2017 to 1-Jan-2022)
measure: Health Care Resources Utilization
timeFrame: From the treatment start date till the data extraction date (1-Jan-2017 to 1-Jan-2022)
measure: Percentage of Participants With Grade 3 or Higher Treatment-related Adverse Events (AEs)
timeFrame: From the treatment start date till the data extraction date (1-Jan-2017 to 1-Jan-2022)
measure: Number of Participants who Experience at Least one Treatment-related AE
timeFrame: From the treatment start date till the data extraction date (1-Jan-2017 to 1-Jan-2022)
measure: Percentage of Participants who Experience at Least one AEs Leading to Treatment Discontinuation
timeFrame: From the treatment start date till the data extraction date (1-Jan-2017 to 1-Jan-2022)
measure: Percentage of Participants Based on Method of Molecular Testing for EGFR Mutation
timeFrame: From the treatment start date till the data extraction date (1-Jan-2017 to 1-Jan-2022)
Other outcomes:
Locations:
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia
state: Andalucia
city: Malaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
state: Andalucia
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
state: Andalucia
city: Badalona
country: Spain
facility: ICO Badalona. Hospital Universitario Germans Trias i Pujol
state: Cataluna
city: Barcelona
country: Spain
facility: Hospital Clinicde Barcelona
state: Cataluna
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
state: Cataluna
city: Gerona
country: Spain
facility: ICO Girona. Hospital Universitario Dr. Josep Trueta
state: Cataluna
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
state: Comunidad De Madrid
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
state: Comunidad De Madrid
city: Madrid
country: Spain
facility: Hospital Universitario Puerta de Hierro
state: Comunidad De Madrid
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
state: Comunidad Valenciana
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic la Fe
state: Comunidad Valenciana
city: A Coruna
country: Spain
facility: Complejo Hospitalario Universitario A Coruna (CHUAC)
state: Galicia
city: Santiago
country: Spain
facility: Complejo Hospitalario Universitario de Santiago (CHUS)
state: Galicia
city: Pamplona
country: Spain
facility: Hospital Universitario de Navarra (HUN)
state: Navarra
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: