UpSwinG: Real World Study on TKI Activity in Uncommon Mutations and Sequencing Giotrif®
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 462
- 试验地点
- 1
- 主要终点
- Time on Treatment With Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI)
研究概览
简要总结
Non-interventional, multi-country, multi-centre cohort study based on existing data from medical records (paper or electronic) or electronic health records of patients with advanced NSCLC harbouring EGFR mutations and treated with an EGFR-TKI
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients
- •Diagnosed with Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFRTKI) naive advanced EGFR mutated non-small cell lung cancer (NSCLC),
- •treated for Epidermal Growth Factor Receptor (EGFR) mutated NSCLC within regular clinical practice.
- •Informed and privacy consent signature must be obtained depending on local regulations.
- •More specific inclusion criteria for each cohort are the following:
- •Uncommon mutation cohort:
- •Patients harbouring uncommon or compound EGFR mutations
- •Patients who started with either afatinib (Gi(l)otrif®), gefitinib (Iressa®), erlotinib (Tarceva®), or osimertinib (Tagrisso®) in the first- or second-line setting within regular clinical practice
- •Patients must have started EGFR-TKI treatment at least 12 months prior to data entry.
- •Sequencing cohort:
- •Patients with common EGFR mutations (Del19, L858R)
- •Patients were treated with afatinib (Gi(l)otrif®) in the first-line setting and for acquired T790M mutation with osimertinib in the second line;
- •Patients must have started osimertinib treatment at least 10 months prior to data entry.
- •Patients treated with osimertinib within an early access program/ compassionate use program (EAP/CUP) are allowed
排除标准
- •Patients treated for EGFR mutated NSCLC within a clinical trial or participated in GioTag study.
- •Patients with active brain metastases at start of EGFR-TKI therapy (independent of treatment line)
- •For uncommon mutation cohort: Patients treated with osimertinib with no further uncommon mutation than acquired T790M Further exclusion criteria apply
研究组 & 干预措施
Uncommon EGFR mutation cohort
This arm included patients with Non-Small Cell Lung Cancer (NSCLC) carrying uncommon mutations in the epidermal growth factor receptor (EGFR) who were treated with the following Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors (EGFR-TKIs) as first or second-line therapy:
- Afatinib (Gi(l)otrif®):50mg or 40mg or 30mg or 20mg tablet once daily as indicated in the approved labels of afatinib (Gi(l)otrif®).
- Erlotinib (Tarceva®): 25mg or 100mg or 150mg tablet once daily as indicated in the approved labels of erlotinib (Tarceva®).
- Gefitinib (IRESSA®): 250mg tablet once daily as indicated in the approved labels of gefitinib (IRESSA®).
- Osimertinib (Tagrisso®): 80 mg or 40 mg tablets once daily as indicated in the approved labels of osimertinib).
In the first- or second-line with a threshold of start of treatment of at least 12 months respectively prior to data entry.
干预措施: Afatinib (Gi(l)otrif®) (Drug)
Uncommon EGFR mutation cohort
This arm included patients with Non-Small Cell Lung Cancer (NSCLC) carrying uncommon mutations in the epidermal growth factor receptor (EGFR) who were treated with the following Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors (EGFR-TKIs) as first or second-line therapy:
- Afatinib (Gi(l)otrif®):50mg or 40mg or 30mg or 20mg tablet once daily as indicated in the approved labels of afatinib (Gi(l)otrif®).
- Erlotinib (Tarceva®): 25mg or 100mg or 150mg tablet once daily as indicated in the approved labels of erlotinib (Tarceva®).
- Gefitinib (IRESSA®): 250mg tablet once daily as indicated in the approved labels of gefitinib (IRESSA®).
- Osimertinib (Tagrisso®): 80 mg or 40 mg tablets once daily as indicated in the approved labels of osimertinib).
In the first- or second-line with a threshold of start of treatment of at least 12 months respectively prior to data entry.
干预措施: Erlotinib (Tarceva®) (Drug)
Uncommon EGFR mutation cohort
This arm included patients with Non-Small Cell Lung Cancer (NSCLC) carrying uncommon mutations in the epidermal growth factor receptor (EGFR) who were treated with the following Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors (EGFR-TKIs) as first or second-line therapy:
- Afatinib (Gi(l)otrif®):50mg or 40mg or 30mg or 20mg tablet once daily as indicated in the approved labels of afatinib (Gi(l)otrif®).
- Erlotinib (Tarceva®): 25mg or 100mg or 150mg tablet once daily as indicated in the approved labels of erlotinib (Tarceva®).
- Gefitinib (IRESSA®): 250mg tablet once daily as indicated in the approved labels of gefitinib (IRESSA®).
- Osimertinib (Tagrisso®): 80 mg or 40 mg tablets once daily as indicated in the approved labels of osimertinib).
In the first- or second-line with a threshold of start of treatment of at least 12 months respectively prior to data entry.
干预措施: Gefitinib (IRESSA®) (Drug)
Uncommon EGFR mutation cohort
This arm included patients with Non-Small Cell Lung Cancer (NSCLC) carrying uncommon mutations in the epidermal growth factor receptor (EGFR) who were treated with the following Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors (EGFR-TKIs) as first or second-line therapy:
- Afatinib (Gi(l)otrif®):50mg or 40mg or 30mg or 20mg tablet once daily as indicated in the approved labels of afatinib (Gi(l)otrif®).
- Erlotinib (Tarceva®): 25mg or 100mg or 150mg tablet once daily as indicated in the approved labels of erlotinib (Tarceva®).
- Gefitinib (IRESSA®): 250mg tablet once daily as indicated in the approved labels of gefitinib (IRESSA®).
- Osimertinib (Tagrisso®): 80 mg or 40 mg tablets once daily as indicated in the approved labels of osimertinib).
In the first- or second-line with a threshold of start of treatment of at least 12 months respectively prior to data entry.
干预措施: Osimertinib (Tagrisso®) (Drug)
Sequencing cohort
This arm included Non-Small Cell Lung Cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) mutation positive who received the following treatment sequence:
- Afatinib (Gi(l)otrif®): 50mg or 40mg or 30mg or 20mg tablet once daily as indicated in the approved labels of afatinib (Gi(l)otrif®) as first line therapy, in the case the T790M resistance mutation was developed (second line therapy) the patients received osimertinib (Tagrisso®): 80 mg or 40 mg tablets once daily as indicated in the approved labels of osimertinib; the threshold of start of osimertinib at least 10 months prior to data entry.
干预措施: Afatinib (Gi(l)otrif®) (Drug)
Sequencing cohort
This arm included Non-Small Cell Lung Cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) mutation positive who received the following treatment sequence:
- Afatinib (Gi(l)otrif®): 50mg or 40mg or 30mg or 20mg tablet once daily as indicated in the approved labels of afatinib (Gi(l)otrif®) as first line therapy, in the case the T790M resistance mutation was developed (second line therapy) the patients received osimertinib (Tagrisso®): 80 mg or 40 mg tablets once daily as indicated in the approved labels of osimertinib; the threshold of start of osimertinib at least 10 months prior to data entry.
干预措施: Osimertinib (Tagrisso®) (Drug)
结局指标
主要结局
Time on Treatment With Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI)
时间窗: Up to 13 years for Uncommon EGFR mutation cohort and up to 6 years for the Sequencing Cohort.
Uncommon Mutation Cohort: Time on treatment with EGFR-TKI assessed as the time from start of EGFR-TKI treatment until the end of treatment or death by any cause is reported. Common mutation cohort: Time on treatment with EGFR-TKI assessed as the time from start of afatinib (Gi(l)otrif®) as first-line treatment until the end of the second line treatment (the last dose of osimertinib) or death date by any cause. Time on treatment was analysed using Kaplan-Meier method, and the median was tabulated along with two-sided 95% confidence interval using the Greenwood's variance estimate.
次要结局
- Number of Participants for Each Category of Methodology Used for Mutational Testing at First Line Treatment Start(At first-line treatment start (i.e. between 2007 and 2019 for the Uncommon Epidermal Growth Factor Receptor (EGFR) mutation cohort and between 2014 and 2018 for the Sequencing Cohort).)
- Number of Participants for Each Type of Biological Samples Used for Mutation Detection at Second Line Treatment Stop/End of Observation(At second-line treatment start (i.e. between 2007 and 16-Jul-2020 for Uncommon Epidermal Growth Factor Receptor (EGFR) mutation cohort and between 2014 and 23-Oct-2020 for the Sequencing Cohort).)
- Overall Survival(Up to 13 years for Uncommon EGFR mutation cohort and up to 6 years for the Sequencing Cohort.)
- Sequencing Cohort: Overall Response Rate to Second-line Treatment Osimertinib(Up to 6 years.)
- Number of Participants for Each Type of Biological Samples Used for Mutation Detection at First Line Treatment Start(At first-line treatment start (i.e. between 2007 and 2019 for the Uncommon Epidermal Growth Factor Receptor (EGFR) mutation cohort and between 2014 and 2018 for Sequencing Cohort).)
- Number of Participants for Each Type of Methodology Used for Mutational Testing at Second-line Treatment Stop/End of Observation(At second-line treatment stop/end of observation (i.e. between 2007 and 16-Jul-2020 for Uncommon Epidermal Growth Factor Receptor (EGFR) mutation cohort and between 2014 and 23-Oct-2020 for the Sequencing Cohort).)
- Uncommon Epidermal Growth Factor Receptor (EGFR) Mutation Cohort: Overall Response Rate to Index Line Treatment(Up to 13 years.)
- Number of Participants for Each Type of Methodology Used for Mutational Testing at Second-line Treatment Start(At second-line treatment start (i.e. between 2007 and 16-Jul-2020 for Uncommon Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitor (EGFR) mutation cohort and between 2014 and 23-Oct-2020 for the Sequencing Cohort).)
- Uncommon Mutation Cohort: Number of Participants for Each Type of Methodology Used for Mutation Detection at Index Therapy Start(Up to 13 years.)
- Uncommon Mutation Cohort: Number of Participants for Each Type of Biological Samples Used for Mutation Detection at Start of First-line Chemotherapy Before Index Line(At start of first-line chemotherapy before index line (i.e. between 2007 and 2019).)
- Sequencing Cohort: Overall Response Rate to First Line Afatinib(Up to 6 years.)
- Uncommon Mutation Cohort: Time on Treatment Until Failure of Second-line (TTF2)(From start of first-line treatment to stop of second-line or death by any cause, up to 13 years.)
- Number of Participants for Each Type of Biological Samples Used for Mutation Detection at Second Line Treatment Start(At second-line treatment start (i.e. between 2007 and 16-Jul-2020 for "Uncommon EGFR mutation cohort" and between 2014 and 23-Oct-2020 for the "Sequencing Cohort)
- Uncommon Cohort: Number of Participants for Each Type of Biological Samples Used for Mutation Detection at Index Therapy Start(Up to 13 years.)
- Uncommon Mutation Cohort: Number of Participants for Each Type of Methodology Used for Mutation Detection at Start of First-line Chemotherapy Before Index Line(At start of first-line chemotherapy before index line (i.e. between 2007 and 2019).)