SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT03133234

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

An Observational, Retrospective, Real World Study of Osimertinib in Ethnic Chinese Patients With Locally Advanced/Metastatic T790M Mutation-Positive Non-small-cell Lung Cancer (NSCLC )Progressed on Previous Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor (TKI).

To assess the effectiveness and safety of osimertinib treatment in a real world setting.

NCT03133234 T790M Positive NSCLC Patients

1 Interventions

Name: osimertinib

Description: Oral dose of 80mg once daily

Type: Drug

EGFR T790M Patients


Primary Outcomes

Description: Overall response rate (ORR), defined as the proportion of patients with a best response of "responding" to treatment by investigator assessment

Measure: ORR

Time: Followed up with 6 months after last patient in

Secondary Outcomes

Description: Progression free survival (PFS), defined as the time from the date of first dose of osimertinib to the date of investigator-assessed disease progression or death from any cause during study. Subjects who have not progressed or died at the time of analysis will be censored at the time of the latest date of assessment

Measure: PFS

Time: Followed up 10 months after last subject in

Description: Average turnaround time.

Measure: T790M mutation testing time

Time: Within 14 days after enrollment date

Description: To assess by number of previous adopted/current/future therapies as recorded on the case report form

Measure: Treatment patterns

Time: Followed up 10 months after last patient in

Description: To assess by number of adverse events as recorded on the case report form.

Measure: Adverse events

Time: Follow up 10 months after last patient in.

Description: To assess by intensity of adverse events as recorded on the case report form, which will be measured by CTCAE grade system

Measure: Adverse event intensity

Time: Follow up 10 months after last patient in.

Description: To assess by proportion of testing samples types as recorded on the case report form.

Measure: T790M mutation testing sample

Time: Within 14 days after enrollment date

Description: To assess by proportion of each testing platform as recorded on the case report form.

Measure: T790M mutation testing platform

Time: Within 14 days after enrollment date

Description: To assess by proportion of EGFR mutation subtype as recorded on the case report form

Measure: EGFR testing mutation subtype

Time: Within 14 days after enrollment date

Time Perspective: Retrospective

Cohort


There is one SNP

SNPs


1 T790M

An Observational, Retrospective, Real World Study of Osimertinib in Ethnic Chinese Patients With Locally Advanced/Metastatic T790M Mutation-Positive Non-small-cell Lung Cancer (NSCLC )Progressed on Previous Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor (TKI).. Effect of Osimertinib in Ethnic Chinese With EGFR and T790M Mutated NSCLC To assess the effectiveness and safety of osimertinib treatment in a real world setting. --- T790M ---

An Observational, Retrospective, Real World Study of Osimertinib in Ethnic Chinese Patients With Locally Advanced/Metastatic T790M Mutation-Positive Non-small-cell Lung Cancer (NSCLC )Progressed on Previous Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor (TKI).. Effect of Osimertinib in Ethnic Chinese With EGFR and T790M Mutated NSCLC To assess the effectiveness and safety of osimertinib treatment in a real world setting. --- T790M --- --- T790M ---

T790M mutation testing time. --- T790M ---

T790M mutation testing sample. --- T790M ---

To assess by proportion of testing samples types as recorded on the case report form.. T790M mutation testing platform. --- T790M ---

Inclusion Criteria: - Above 18 years of age; - Locally advanced (stage IIIB) or metastatic (stage IV) NSCLC, not amenable to curative surgery or radiotherapy - Confirmed T790M mutation - Progressed on previous EGFR TKI treatment. --- T790M ---

Patients may have also received additional lines of treatment - Received osimertinib treatment in the participating site between May 1st and Oct 31st 2016 Exclusion Criteria: • Enrolment in studies that prohibit any participation in this observational study Inclusion Criteria: - Above 18 years of age; - Locally advanced (stage IIIB) or metastatic (stage IV) NSCLC, not amenable to curative surgery or radiotherapy - Confirmed T790M mutation - Progressed on previous EGFR TKI treatment. --- T790M ---

Patients may have also received additional lines of treatment - Received osimertinib treatment in the participating site between May 1st and Oct 31st 2016 Exclusion Criteria: • Enrolment in studies that prohibit any participation in this observational study T790M Positive NSCLC Patients The current study will not only assess the effectiveness of osimertinib treatment in a real world setting, but will also help us to understand the real-world testing patterns among T790M mutation positive locally advanced or metastatic NSCLC patients who have progressed after EGFR TKI treatment. --- T790M ---

Patients may have also received additional lines of treatment - Received osimertinib treatment in the participating site between May 1st and Oct 31st 2016 Exclusion Criteria: • Enrolment in studies that prohibit any participation in this observational study T790M Positive NSCLC Patients The current study will not only assess the effectiveness of osimertinib treatment in a real world setting, but will also help us to understand the real-world testing patterns among T790M mutation positive locally advanced or metastatic NSCLC patients who have progressed after EGFR TKI treatment. --- T790M --- --- T790M ---



HPO Nodes