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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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:
In the first- or second-line with a threshold of start of treatment of at least 12 months respectively prior to data entry. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Afatinib (Gi(l)otrif®) | Drug | Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI) as first or second-line therapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time on Treatment With Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI) | 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. | Up to 13 years for Uncommon EGFR mutation cohort and up to 6 years for the Sequencing Cohort. |
| Measure | Description | Time Frame |
|---|---|---|
| Uncommon Epidermal Growth Factor Receptor (EGFR) Mutation Cohort: Overall Response Rate to Index Line Treatment | Overall response rate (ORR) using RECIST criteria as assessed by investigator. ORR to index line Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitor (EGFR-TKI) treatment is reported (ORR is defined as number of patients with complete or partial response evaluated by Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.1)). (Per RECIST 1.1: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR). |
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Inclusion Criteria:
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:
5. Patients with common EGFR mutations (Del19, L858R) 6. Patients were treated with afatinib (Gi(l)otrif®) in the first-line setting and for acquired T790M mutation with osimertinib in the second line; 7. 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
Exclusion Criteria:
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Adult patients diagnosed with Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFRTKI) naïve advanced EGFR mutated non-small cell lung cancer (NSCLC),
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Marsden Hospital | London | SW3 6JJ | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35274704 | Derived | Popat S, Hsia TC, Hung JY, Jung HA, Shih JY, Park CK, Lee SH, Okamoto T, Ahn HK, Lee YC, Sato Y, Lee SS, Mascaux C, Daoud H, Marten A, Miura S. Tyrosine Kinase Inhibitor Activity in Patients with NSCLC Harboring Uncommon EGFR Mutations: A Retrospective International Cohort Study (UpSwinG). Oncologist. 2022 Apr 5;27(4):255-265. doi: 10.1093/oncolo/oyac022. |
| Label | URL |
|---|---|
| Related Info | View source |
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Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).
For more details refer to: https://www.mystudywindow.com/msw/datatransparency
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Every patient who fulfilled inclusion and exclusion criteria and agreed to participate in the study was selected until the required sample size was achieved. Deceased and untraceable patients were enrolled whenever possible and discussed with the local authorities.
A Real world, non-interventional study based on existing data from medical records or electronic health records. The study aimed to collect more information on the benefit of individual Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors (EGFR-TKIs) treatment for the uncommon mutations and the overall benefit for the sequential EGFR TKI treatment with afatinib and osimertinib for the common EGFR mutations on patients with Non-Small Cell Lung Cancer (NSCLC).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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:
In the first- or second-line with a threshold of start of treatment of at least 12 months respectively prior to data entry. |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 20, 2020 | Jul 8, 2022 |
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| Erlotinib (Tarceva®) | Drug | Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI) as first or second-line therapy. |
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| Gefitinib (IRESSA®) | Drug | Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI) as first or second-line therapy. |
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| Osimertinib (Tagrisso®) | Drug | Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI) as first or second-line therapy. |
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| Afatinib (Gi(l)otrif®) | Drug | As first line therapy. |
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| Osimertinib (Tagrisso®) | Drug | In the case the T790M resistance mutation was developed (second line therapy). |
|
| Up to 13 years. |
| Sequencing Cohort: Overall Response Rate to First Line Afatinib | Overall response rate (ORR) using RECIST criteria as assessed by investigator. Overall response rate to first line afatinib treatment for the Common Epidermal Growth Factor Receptor (EGFR) mutation cohort is reported. (ORR is defined as number of patients with complete or partial response evaluated by Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.1)). (Per RECIST 1.1: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR). | Up to 6 years. |
| Sequencing Cohort: Overall Response Rate to Second-line Treatment Osimertinib | Overall response rate (ORR) using RECIST criteria as assessed by investigator. Overall response rate to second-line treatment (Osimertinib) is reported. (ORR is defined as number of patients with complete or partial response evaluated by Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.1)). (Per RECIST 1.1: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR). | Up to 6 years. |
| Overall Survival | Uncommon Mutation Cohort: Overall survival since index line treatment start of Tyrosine Kinase Inhibitor (TKI) medication administered per generation until death date by any cause or the end of index line is reported. Sequencing cohort: Overall survival for since first-line afatinib treatment start until death date by any cause or the end of index line. Kaplan-Meier estimates of quartiles of time to death were computed (with their 95% Confidence Intervals, using Greenwood's variance estimate. | Up to 13 years for Uncommon EGFR mutation cohort and up to 6 years for the Sequencing Cohort. |
| Number of Participants for Each Type of Biological Samples Used for Mutation Detection at First Line Treatment Start | Number of participants for each type of biological samples used for mutation detection at first line treatment start is reported. The reported types of biological samples are:
| 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 Category of Methodology Used for Mutational Testing at First Line Treatment Start | Number of participants for each type of methodologies used for mutational testing is reported. The reported types of methodology are:
| 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). |
| Uncommon Mutation Cohort: Time on Treatment Until Failure of Second-line (TTF2) | Time on treatment until failure of second-line (TTF2), defined as time elapsed from start of first-line treatment (regardless the type of treatment) to stop of second-line (regardless of the type of treatment) or death by any cause is reported. Kaplan-Meier estimates of quartiles of time to second-line treatment failure were computed (with their 95% Confidence Intervals, using Greenwood's variance estimate). | 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 | Number of participants for each type of biological samples used for mutation detection at second line treatment start is reported. The reported types of biological samples are:
For the Sequencing cohort second-line treatment start is initiated by the beginning of the therapy with Osimertinib. | 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 |
| Number of Participants for Each Type of Biological Samples Used for Mutation Detection at Second Line Treatment Stop/End of Observation | Number of participants for each type of biological samples used for mutation detection at second line treatment stop/end of observation is reported. The reported categories of biological samples are:
| 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). |
| Uncommon Cohort: Number of Participants for Each Type of Biological Samples Used for Mutation Detection at Index Therapy Start | Number of participants for each type of biological samples used for mutation detection at index therapy start (index therapy refers to therapy switch from first-line chemotherapy to second-line Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitor (EGFR-TKI) therapy (index line)) is reported. The reported categories of biological samples are:
| Up to 13 years. |
| Number of Participants for Each Type of Methodology Used for Mutational Testing at Second-line Treatment Start | Number of participants for each type of methodology used for mutational testing at second-line treatment start is reported. The reported types of methodologies are:
| 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). |
| Number of Participants for Each Type of Methodology Used for Mutational Testing at Second-line Treatment Stop/End of Observation | Number of participants for each type of methodology used for mutational testing is reported. The reported types of methodologies are:
| 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 Mutation Cohort: Number of Participants for Each Type of Methodology Used for Mutation Detection at Index Therapy Start | Number of participants for each type of methodology used for mutation detection at index therapy start is reported. Index therapy refers to therapy switch from first-line chemotherapy to second-line Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitor (EGFR-TKI) therapy (index line). The reported categories of methodology are:
| 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 | Number of participants for each type of methodology used for mutation detection at start of first-line chemotherapy before index line is reported. The reported types of methodologies are:
Index therapy refers to therapy switch from first-line chemotherapy to second-line Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitor (EGFR-TKI) therapy (index line). | At start of first-line chemotherapy before index line (i.e. between 2007 and 2019). |
| 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 | Number of participants for each type of biological samples used for mutation detection at start of first-line chemotherapy before index line is reported. Index therapy refers to therapy switch from first-line chemotherapy to second-line Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitor (EGFR-TKI) therapy (index line). The reported types of biological samples are:
| At start of first-line chemotherapy before index line (i.e. between 2007 and 2019). |
| FG001 | 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. |
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| Eligible Patients |
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| COMPLETED |
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| NOT COMPLETED |
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Eligible Patients set (Uncommon mutation and common mutation cohorts): All enrolled patients meeting all the inclusion and exclusion criteria to be evaluable.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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:
In the first- or second-line with a threshold of start of treatment of at least 12 months respectively prior to data entry. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time on Treatment With Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI) | 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. | Eligible Patients set (Uncommon mutation cohort): All enrolled patients meeting all the inclusion and exclusion criteria to be evaluable. Eligible Patients set (Sequencing cohort): All enrolled patients meeting all the inclusion and exclusion criteria to be evaluable. | Posted | Median | 95% Confidence Interval | Months | Up to 13 years for Uncommon EGFR mutation cohort and up to 6 years for the Sequencing Cohort. |
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| Secondary | Uncommon Epidermal Growth Factor Receptor (EGFR) Mutation Cohort: Overall Response Rate to Index Line Treatment | Overall response rate (ORR) using RECIST criteria as assessed by investigator. ORR to index line Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitor (EGFR-TKI) treatment is reported (ORR is defined as number of patients with complete or partial response evaluated by Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.1)). (Per RECIST 1.1: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR). | Eligible Patients set (Uncommon mutation cohort): All enrolled patients meeting all the inclusion and exclusion criteria to be evaluable. | Posted | Count of Participants | Participants | Up to 13 years. |
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| Secondary | Sequencing Cohort: Overall Response Rate to First Line Afatinib | Overall response rate (ORR) using RECIST criteria as assessed by investigator. Overall response rate to first line afatinib treatment for the Common Epidermal Growth Factor Receptor (EGFR) mutation cohort is reported. (ORR is defined as number of patients with complete or partial response evaluated by Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.1)). (Per RECIST 1.1: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR). | Eligible Patients set (Sequencing cohort): All enrolled patients meeting all the inclusion and exclusion criteria to be evaluable. | Posted | Count of Participants | Participants | Up to 6 years. |
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| Secondary | Sequencing Cohort: Overall Response Rate to Second-line Treatment Osimertinib | Overall response rate (ORR) using RECIST criteria as assessed by investigator. Overall response rate to second-line treatment (Osimertinib) is reported. (ORR is defined as number of patients with complete or partial response evaluated by Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.1)). (Per RECIST 1.1: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR). | Eligible Patients set (Sequencing cohort): All enrolled patients meeting all the inclusion and exclusion criteria to be evaluable. | Posted | Count of Participants | Participants | Up to 6 years. |
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| Secondary | Overall Survival | Uncommon Mutation Cohort: Overall survival since index line treatment start of Tyrosine Kinase Inhibitor (TKI) medication administered per generation until death date by any cause or the end of index line is reported. Sequencing cohort: Overall survival for since first-line afatinib treatment start until death date by any cause or the end of index line. Kaplan-Meier estimates of quartiles of time to death were computed (with their 95% Confidence Intervals, using Greenwood's variance estimate. | Eligible Patients set (Uncommon mutation cohort): All enrolled patients meeting all the inclusion and exclusion criteria to be evaluable. Eligible Patients set (Sequencing cohort): All enrolled patients meeting all the inclusion and exclusion criteria to be evaluable. | Posted | Median | 95% Confidence Interval | Months | Up to 13 years for Uncommon EGFR mutation cohort and up to 6 years for the Sequencing Cohort. |
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| Secondary | Number of Participants for Each Type of Biological Samples Used for Mutation Detection at First Line Treatment Start | Number of participants for each type of biological samples used for mutation detection at first line treatment start is reported. The reported types of biological samples are:
| Eligible Patients set (Uncommon mutation cohort): All enrolled patients meeting all the inclusion and exclusion criteria to be evaluable. Eligible Patients set (Sequencing cohort): All enrolled patients meeting all the inclusion and exclusion criteria to be evaluable. | Posted | Count of Participants | Participants | 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). |
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| Secondary | Number of Participants for Each Category of Methodology Used for Mutational Testing at First Line Treatment Start | Number of participants for each type of methodologies used for mutational testing is reported. The reported types of methodology are:
| Eligible Patients set (Uncommon mutation cohort): All enrolled patients meeting all the inclusion and exclusion criteria to be evaluable. Eligible Patients set (Sequencing cohort): All enrolled patients meeting all the inclusion and exclusion criteria to be evaluable. | Posted | Count of Participants | Participants | 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). |
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| Secondary | Uncommon Mutation Cohort: Time on Treatment Until Failure of Second-line (TTF2) | Time on treatment until failure of second-line (TTF2), defined as time elapsed from start of first-line treatment (regardless the type of treatment) to stop of second-line (regardless of the type of treatment) or death by any cause is reported. Kaplan-Meier estimates of quartiles of time to second-line treatment failure were computed (with their 95% Confidence Intervals, using Greenwood's variance estimate). | Eligible Patients set (Uncommon mutation cohort): All enrolled patients meeting all the inclusion and exclusion criteria to be evaluable and who were initiated on a second line treatment. | Posted | Median | 95% Confidence Interval | Months | From start of first-line treatment to stop of second-line or death by any cause, up to 13 years. |
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| Secondary | Number of Participants for Each Type of Biological Samples Used for Mutation Detection at Second Line Treatment Start | Number of participants for each type of biological samples used for mutation detection at second line treatment start is reported. The reported types of biological samples are:
For the Sequencing cohort second-line treatment start is initiated by the beginning of the therapy with Osimertinib. | Eligible Patients set: All enrolled patients meeting all the inclusion and exclusion criteria to be evaluable and who were initiated on a second line treatment. For the Uncommon EGFR mutation cohort only patients with >1 Non-Small Cell Lung Cancer (NSCLC) with re-evaluated mutational status. | Posted | Count of Participants | Participants | 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 |
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| Secondary | Number of Participants for Each Type of Biological Samples Used for Mutation Detection at Second Line Treatment Stop/End of Observation | Number of participants for each type of biological samples used for mutation detection at second line treatment stop/end of observation is reported. The reported categories of biological samples are:
| Eligible Patients set: All enrolled patients meeting all the inclusion and exclusion criteria to be evaluable. For the Uncommon EGFR mutation cohort eligible patients with >1 Non-Small Cell Lung Cancer (NSCLC) line with re-evaluated mutational status are reported. | Posted | Count of Participants | Participants | 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). |
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| Secondary | Uncommon Cohort: Number of Participants for Each Type of Biological Samples Used for Mutation Detection at Index Therapy Start | Number of participants for each type of biological samples used for mutation detection at index therapy start (index therapy refers to therapy switch from first-line chemotherapy to second-line Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitor (EGFR-TKI) therapy (index line)) is reported. The reported categories of biological samples are:
| Eligible Patients set: All enrolled patients meeting all the inclusion and exclusion criteria to be evaluable. 16 patients in the Uncommon EGFR mutation cohort who switched from first-line chemotherapy to second-line EGFR-TKI therapy for which EGFR mutational status was not re-evaluated at start of second-line treatment were not included in this group. | Posted | Count of Participants | Participants | Up to 13 years. |
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| Secondary | Number of Participants for Each Type of Methodology Used for Mutational Testing at Second-line Treatment Start | Number of participants for each type of methodology used for mutational testing at second-line treatment start is reported. The reported types of methodologies are:
| Eligible Patients set: All enrolled patients meeting all the inclusion and exclusion criteria to be evaluable and who were initiated on a second line treatment. For the Uncommon EGFR mutation cohort only patients with >1 Non-Small Cell Lung Cancer (NSCLC) with re-evaluated mutational status. | Posted | Count of Participants | Participants | 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). |
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| Secondary | Number of Participants for Each Type of Methodology Used for Mutational Testing at Second-line Treatment Stop/End of Observation | Number of participants for each type of methodology used for mutational testing is reported. The reported types of methodologies are:
| Eligible Patients set: All enrolled patients meeting all the inclusion and exclusion criteria to be evaluable. | Posted | Count of Participants | Participants | 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). |
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| Secondary | Uncommon Mutation Cohort: Number of Participants for Each Type of Methodology Used for Mutation Detection at Index Therapy Start | Number of participants for each type of methodology used for mutation detection at index therapy start is reported. Index therapy refers to therapy switch from first-line chemotherapy to second-line Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitor (EGFR-TKI) therapy (index line). The reported categories of methodology are:
| Eligible Patients set: All enrolled patients meeting all the inclusion and exclusion criteria to be evaluable. 16 patients in the "Uncommon EGFR mutation cohort" who switched from first-line chemotherapy to second-line EGFR-TKI therapy for which EGFR mutational status was not re-evaluated at start of second-line treatment were not included in this group. | Posted | Count of Participants | Participants | Up to 13 years. |
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| Secondary | Uncommon Mutation Cohort: Number of Participants for Each Type of Methodology Used for Mutation Detection at Start of First-line Chemotherapy Before Index Line | Number of participants for each type of methodology used for mutation detection at start of first-line chemotherapy before index line is reported. The reported types of methodologies are:
Index therapy refers to therapy switch from first-line chemotherapy to second-line Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitor (EGFR-TKI) therapy (index line). | Eligible Patients set: All enrolled patients meeting all the inclusion and exclusion criteria to be evaluable. Only patients switching from first-line chemotherapy to second-line EGFR-TKI therapy (index line) for which EGFR mutational status was not re-evaluated at start of second-line treatment are reported. | Posted | Count of Participants | Participants | At start of first-line chemotherapy before index line (i.e. between 2007 and 2019). |
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| Secondary | 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 | Number of participants for each type of biological samples used for mutation detection at start of first-line chemotherapy before index line is reported. Index therapy refers to therapy switch from first-line chemotherapy to second-line Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitor (EGFR-TKI) therapy (index line). The reported types of biological samples are:
| Eligible Patients set: All enrolled patients meeting all the inclusion and exclusion criteria to be evaluable. Only patients switching from first-line chemotherapy to second-line EGFR-TKI therapy (index line) for which EGFR mutational status was not re-evaluated at start of second-line treatment are reported. | Posted | Count of Participants | Participants | At start of first-line chemotherapy before index line (i.e. between 2007 and 2019). |
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From the start of the first-line treatment between 2007 and 2019, until Database Lock in 2021. Up to 14 years.
A Safety analysis was included, reporting adverse drug reaction (ADR) information that was provided by the Pharmacovigilance (PV) Department at Boehringer Ingelheim, which was linked to patient data. The safety analysis included no adverse events beyond ADR and fatal adverse events (AEs). The safety analysis as per statistical analysis plan is reported on the overall enrolled patients set for those subjects that have not missing safety data.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 44 | 12 | 44 | 41 | 44 |
| EG001 | 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:
In the first- or second-line with a threshold of start of treatment of at least 12 months respectively prior to data entry. | 0 | 35 | 6 | 35 | 30 | 35 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Inflammation | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Nail fold inflammation | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
|
As in all studies based on secondary use of data, the risk of missing data shall be taken into consideration. Stratified analyses include no formal testing for statistical significance since such analyses have a descriptive exploratory purpose. In fact, no a priori hypotheses were defined. Patient's duration of observation was different for each subject without specific censoring rules by protocol, and there were no limitations on time periods for starting treatments by protocol.
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 11, 2020 | Jul 8, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077716 | Afatinib |
| D000069347 | Erlotinib Hydrochloride |
| D000077156 | Gefitinib |
| C000596361 | osimertinib |
| ID | Term |
|---|---|
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Counts |
|---|
| Participants |
|
|
| OG001 | 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. |
|
|
| OG001 | 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. |
|
|
| OG001 | 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. |
|
|
|
|
| OG001 | 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. |
|
|
| OG001 | 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. |
|
|
|
|
| OG001 | 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. |
|
|
| OG001 | 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. |
|
|
|
|
|
|
|
|