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

Non-small Cell Lung Cancer (NSCLC) Clinical Trial

— ermEX-20  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05419700
• Other study ID #: TAK-788-5009
• Status: Completed
• Start date: August 5, 2022
• Est. completion date: September 1, 2023

Study information

• Verified date: September 2023
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: September 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer (NSCLC)

Locations

Country	Name	City	State
Spain	Complejo Hospitalario Universitario A Coruna (CHUAC)	A Coruna	Galicia
Spain	Hospital General Universitario de Alicante	Alicante	Comunidad Valenciana
Spain	ICO Badalona. Hospital Universitario Germans Trias i Pujol	Badalona	Cataluna
Spain	Hospital Clinicde Barcelona	Barcelona	Cataluna
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona	Cataluna
Spain	Hospital Universitario Reina Sofia	Cordoba	Andalucia
Spain	ICO Girona. Hospital Universitario Dr. Josep Trueta	Gerona	Cataluna
Spain	Hospital Universitario 12 de Octubre	Madrid	Comunidad De Madrid
Spain	Hospital Universitario Puerta de Hierro	Madrid	Comunidad De Madrid
Spain	Hospital Universitario Ramon y Cajal	Madrid	Comunidad De Madrid
Spain	Hospital Universitario Virgen de la Victoria	Malaga	Andalucia
Spain	Hospital Universitario de Navarra (HUN)	Pamplona	Navarra
Spain	Complejo Hospitalario Universitario de Santiago (CHUS)	Santiago	Galicia
Spain	Hospital Universitario Virgen del Rocio	Sevilla	Andalucia
Spain	Hospital Universitari i Politecnic la Fe	Valencia	Comunidad Valenciana

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall Response Rate (ORR)	ORR is defined as the percentage of participants on a given treatment that have at least one partial remission (PR)/complete remission (CR) assessment determination within 3 months after initiation of treatment. CR: defined as disappearance of all target lesions, non-target lesions, no new lesions, and normalization of tumor marker level. PR: defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesions. ORR will be assessed by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1).	From the treatment start date till the data extraction date (1-Jan-2017 to 1-Jan-2022)
Secondary	Progression-free Survival (PFS)	PFS is defined as the time from treatment start until disease progression (PD) or death. PD: defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of longest diameter recorded since the treatment started or the appearance of one or more new lesions. PFS will be assessed by RECIST 1.1.	From the treatment start date till the data extraction date (1-Jan-2017 to 1-Jan-2022)
Secondary	Disease Control Rate (DCR)	DCR is defined as the percentage of participants on a given treatment that have at least one PR/CR/stable disease (SD) and no PD assessment determination within 3 months after treatment start. CR: defined as disappearance of all target lesions, non-target lesions, no new lesions, and normalization of tumor marker level. PR: defined as at least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesions. SD: defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD: defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of longest diameter recorded since the treatment started or the appearance of one or more new lesions. DCR will be assessed by RECIST 1.1.	From the treatment start date till the data extraction date (1-Jan-2017 to 1-Jan-2022)
Secondary	Time-to-treatment Failure (TTF)	TTF is defined as the time from treatment start until treatment discontinuation due to any reason including toxicity, PD, or death. PD: defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of longest diameter recorded since the treatment started or the appearance of one or more new lesions. TTF will be assessed by RECIST 1.1.	From the treatment start date till the data extraction date (1-Jan-2017 to 1-Jan-2022)
Secondary	Overall Survival (OS)	OS is defined as the time from treatment start until death from any cause or the last follow-up. OS will be assessed by RECIST 1.1.	From the treatment start date till the data extraction date (1-Jan-2017 to 1-Jan-2022)
Secondary	Health Care Resources Utilization	Health care resources utilization including information related with direct costs (hospitalizations, tests, computed tomography [CT], positron emission tomography [PET], magnetic resonance imaging [MRI]) will be reported.	From the treatment start date till the data extraction date (1-Jan-2017 to 1-Jan-2022)
Secondary	Percentage of Participants With Grade 3 or Higher Treatment-related Adverse Events (AEs)	Treatment-related grade 3 or higher AE will be reported. Treatment-related AE grades will be evaluated as per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.	From the treatment start date till the data extraction date (1-Jan-2017 to 1-Jan-2022)
Secondary	Number of Participants who Experience at Least one Treatment-related AE	Participants with at least one treatment-related AE will be reported. An AE is defined as any untoward medical occurrence in a participant administered a medicinal product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, a new disease or worsening in severity or frequency of a concomitant disease, temporally associated with the use of a medicinal product, whether or not the event is considered causally related to the use of the product.	From the treatment start date till the data extraction date (1-Jan-2017 to 1-Jan-2022)
Secondary	Percentage of Participants who Experience at Least one AEs Leading to Treatment Discontinuation		From the treatment start date till the data extraction date (1-Jan-2017 to 1-Jan-2022)
Secondary	Percentage of Participants Based on Method of Molecular Testing for EGFR Mutation	Participants will be reported based on the method of molecular testing to analyze EGFR mutations (for example, polymerase chain reaction [PCR], PCR-reverse transcription [RT], Next-generation sequencing [NGS]).	From the treatment start date till the data extraction date (1-Jan-2017 to 1-Jan-2022)

External Links

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