Royal Marsden Hospital
London, SW3 6JJ, United Kingdom
NCT Number: NCT04179890
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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Notify Me18 year and older
All sexes
Observational
London, SW3 6JJ, United Kingdom
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
More specific inclusion criteria for each cohort are the following:
Uncommon mutation cohort:
Sequencing cohort:
Patients treated with osimertinib within an early access program/ compassionate use program (EAP/CUP) are allowed
Exclusion criteria
Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI) as first or second-line therapy.
Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI) as first or second-line therapy.
Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI) as first or second-line therapy.
Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI) as first or second-line therapy.
Time frame: 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.
Time frame: Up to 13 years.
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).
Time frame: Up to 6 years.
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).
Time frame: Up to 6 years.
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).
Time frame: Up to 13 years for Uncommon EGFR mutation cohort and up to 6 years for the Sequencing Cohort.
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.
Time frame: 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 biological samples used for mutation detection at first line treatment start is reported.
The reported types of biological samples are:
Time frame: 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 methodologies used for mutational testing is reported.
The reported types of methodology are:
Time frame: From start of first-line treatment to stop of second-line or death by any cause, up to 13 years.
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).
Time frame: 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 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.
Time frame: 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).
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:
Time frame: Up to 13 years.
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:
Time frame: 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 start is reported.
The reported types of methodologies are:
Time frame: 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).
Number of participants for each type of methodology used for mutational testing is reported.
The reported types of methodologies are:
Time frame: Up to 13 years.
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:
Time frame: At start of first-line chemotherapy before index line (i.e. between 2007 and 2019).
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).
Time frame: At start of first-line chemotherapy before index line (i.e. between 2007 and 2019).
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:
Boehringer Ingelheim
Industry
UpSwinG: Real World Study on TKI Activity in Uncommon Mutations and Sequencing Giotrif®
Acronym: UpSwinG
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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