ermEX-20: A Spanish Medical Record Review of Clinical Characteristics and Outcomes in Non-small Cell Lung Cancer Participants With EGFR Exon 20 Insertion
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Outcome Measures
Primary Outcome Measures
- Percentage of Participants Based on Type of EGFR Mutation [From the treatment start date till the data extraction date (1-Jan-2017 to 1-Jan-2022)]
Percentage of participants will be reported based on type of EGFR mutation and its variant: EGFR exon 20 insertion or compound mutations.
Secondary Outcome Measures
- Overall Response Rate (ORR) [From the treatment start date till the data extraction date (1-Jan-2017 to 1-Jan-2022)]
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).
- Progression-free Survival (PFS) [From the treatment start date till the data extraction date (1-Jan-2017 to 1-Jan-2022)]
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.
- Disease Control Rate (DCR) [From the treatment start date till the data extraction date (1-Jan-2017 to 1-Jan-2022)]
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.
- Time-to-treatment Failure (TTF) [From the treatment start date till the data extraction date (1-Jan-2017 to 1-Jan-2022)]
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.
- Overall Survival (OS) [From the treatment start date till the data extraction date (1-Jan-2017 to 1-Jan-2022)]
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.
- Health Care Resources Utilization [From the treatment start date till the data extraction date (1-Jan-2017 to 1-Jan-2022)]
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.
- Percentage of Participants With Grade 3 or Higher Treatment-related Adverse Events (AEs) [From the treatment start date till the data extraction date (1-Jan-2017 to 1-Jan-2022)]
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.
- Number of Participants who Experience at Least one Treatment-related AE [From the treatment start date till the data extraction date (1-Jan-2017 to 1-Jan-2022)]
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.
- 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)]
- Percentage of Participants Based on Method of Molecular Testing for EGFR Mutation [From the treatment start date till the data extraction date (1-Jan-2017 to 1-Jan-2022)]
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]).
Eligibility Criteria
Criteria
Inclusion Criteria:
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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.
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Participants with detection of an EGFR exon 20 insertion mutation, at any point.
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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:
- Participants do not meet any of the inclusion criteria.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Universitario Reina Sofia | Cordoba | Andalucia | Spain | 14004 |
| 2 | Hospital Universitario Virgen de la Victoria | Malaga | Andalucia | Spain | 29010 |
| 3 | Hospital Universitario Virgen del Rocio | Sevilla | Andalucia | Spain | 41013 |
| 4 | ICO Badalona. Hospital Universitario Germans Trias i Pujol | Badalona | Cataluna | Spain | 8916 |
| 5 | Hospital Clinicde Barcelona | Barcelona | Cataluna | Spain | 08036 |
| 6 | Hospital de la Santa Creu i Sant Pau | Barcelona | Cataluna | Spain | 08041 |
| 7 | ICO Girona. Hospital Universitario Dr. Josep Trueta | Gerona | Cataluna | Spain | 17007 |
| 8 | Hospital Universitario Ramon y Cajal | Madrid | Comunidad De Madrid | Spain | 28034 |
| 9 | Hospital Universitario 12 de Octubre | Madrid | Comunidad De Madrid | Spain | 28041 |
| 10 | Hospital Universitario Puerta de Hierro | Madrid | Comunidad De Madrid | Spain | 28222 |
| 11 | Hospital General Universitario de Alicante | Alicante | Comunidad Valenciana | Spain | 03010 |
| 12 | Hospital Universitari i Politecnic la Fe | Valencia | Comunidad Valenciana | Spain | 46026 |
| 13 | Complejo Hospitalario Universitario A Coruna (CHUAC) | A Coruna | Galicia | Spain | 15006 |
| 14 | Complejo Hospitalario Universitario de Santiago (CHUS) | Santiago | Galicia | Spain | 15706 |
| 15 | Hospital Universitario de Navarra (HUN) | Pamplona | Navarra | Spain | 31008 |
Sponsors and Collaborators
- Takeda
Investigators
- Study Director: Study Director, Takeda
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TAK-788-5009