Osimertinib for NSCLC With EGFR Exon 20 Insertion Mutation
NCT03414814
Bronchial Neoplasms, Carcinoma, Bronchogenic
Seoul, South Korea
View Trial DetailsNCT Number: NCT04207775
To estimate parameters associated with treatment patterns and related clinical outcomes.Including physician reported PFS and OS.
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Notify Me18 year and older
All sexes
Observational
Research Site, Beijing, China
The objectives of this study are to assess molecular testing, treatment patterns, and associated clinical outcomes among patients with epidermal growth factor receptor (EGFR) mutation-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed from first-line EGFR-TKI (tyrosine kinase inhibitor) therapy. This study is descriptive in nature and does not attempt to test any specific a priori hypotheses
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: From enrolment to follow-up of up to 36 months
from date of second-line treatment initiation until progression by RECIST1.1 criteria, or death
Time frame: From enrolment to follow-up of up to 36 months
the date of second-line treatment initiation until death from any cause(only for patients receiving 2L CT and 2L TKI, separately)
Time frame: From enrolment to follow-up of up to 36 months
Time to initiate second line therapy from RECIST1.1 defined progression from 1L treatment
Time frame: From enrolment to follow-up of up to 36 months
Response rate reported by physician or judged by Recist1.1 after receiving any pattern of therapy
Time frame: From enrolment to follow-up of up to 36 months
For each line of chemotherapy received but not limited in:Therapy regimen,Therapy duration measured as time from therapy start date to time of therapy end date,Number of cycles received,Reason for cessation of therapy
Time frame: From enrolment to follow-up of up to 36 months
For each line of immunotherapy received but not limited in:Therapy regimen,Therapy duration measured as time from therapy start date to time of therapy end date,Number of cycles received,Reason for cessation of therapy
Time frame: From enrolment to follow-up of up to 36 months
For each line of targeted therapy received but not limited in:Therapy regimen,Therapy duration measured as time from therapy start date to time of therapy end date,Number of cycles received,Reason for cessation of therapy
Time frame: From enrolment to follow-up of up to 36 months
For each line of local therapy received but not limited in:Therapy regimen,Therapy duration measured as time from therapy start date to time of therapy end date,Number of cycles received,Reason for cessation of therapy
Time frame: From enrolment to follow-up of up to 36 months
Any palliative/supportive care received
Time frame: From enrolment to follow-up of up to 36 months
To estimate parameters in the target population associated with molecular testing patterns, including molecular testing sample type
Time frame: From enrolment to follow-up of up to 36 months
To estimate parameters in the target population associated with molecular testing patterns, including molecular test outcome
Time frame: From enrolment to follow-up of up to 36 months
To estimate parameters associated with molecular testing patterns, including changes in testing rate over time
Time frame: From enrolment to follow-up of up to 36 months
Molecular testing rate defined as the number of patients identified as having received molecular testing divided by the number of patients
Time frame: From enrolment to follow-up of up to 36 months
Time from the RECIST defined progression date to molecular testing
Time frame: From enrolment to follow-up of up to 36 months
To estimate parameters in the target population associated with molecular testing patterns, including molecular testing method of biopsy
Time frame: From enrolment to follow-up of up to 36 months
To estimate parameters in the target population associated with molecular testing patterns, including molecular testing turnaround time
Time frame: From enrolment to follow-up of up to 36 months
To estimate parameters in the target population associated with molecular testing patterns, including molecular test type
Time frame: From enrolment to follow-up of up to 36 months
To estimate parameters in the target population associated with molecular testing patterns, including reason for molecular testing
Time frame: From enrolment to follow-up of up to 36 months
To estimate parameters in the target population associated with molecular testing patterns, including molecular testing laboratory type
Time frame: From enrolment to follow-up of up to 36 months
To estimate parameters in the target population associated with molecular testing patterns including reason for not performing a molecular test
Time frame: From enrolment to follow-up of up to 36 months
To estimate parameters in the target population associated with molecular testing patterns including molecular testing result of mutation status
Time frame: From enrolment to follow-up of up to 36 months
To estimate parameters in the target population associated with molecular testing patterns, including molecular result of mutation type
Time frame: From enrolment to follow-up of up to 36 months
To estimate parameters in the target population associated with molecular testing patterns, including histologic/phenotypic transformation
Time frame: From enrolment to follow-up of up to 36 months
Overall CNS metastases rate, defined as the number of patients developing CNS metastases divided by the number of evaluable patients (From start of 2L therapy)
Time frame: From enrolment to follow-up of up to 36 months
Brain metastases rate, defined as the number of patients developing brain metastases divided by the number of evaluable patients
Time frame: From enrolment to follow-up of up to 36 months
Leptomeningeal metastases rate, defined as the number of patients developing leptomeningeal metastases divided by the number of evaluable patients
Time frame: From enrolment to follow-up of up to 36 months
Treatments for CNS metastases, including type of treatment
Time frame: From enrolment to follow-up of up to 36 months
Treatments for CNS metastases, including dates of treatment
Time frame: From enrolment to follow-up of up to 36 months
To assess patient-reported HRQoL using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 items (EORTC QLQ-C30) and European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Lung Cancer 13 items (EORTC QLQ-LC13)
Time frame: From enrolment to follow-up of up to 36 months
To assess patient-reported HRQoL using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 items (EORTC QLQ-C30) and European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Lung Cancer 13 items (EORTC QLQ-LC13)
AstraZeneca
Industry
Real World Molecular Testing, Treatment Patterns, and Clinical Outcomes in EGFR Mutation-Positive, Locally Advanced or Metastatic Chinese NSCLC Patients, Who Have Progressed From First-line EGFR-TKI Therapy (PISCES)
Acronym: PISCES
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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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