Real World Study in Locally Advanced or Metastatic NSCLC Patients, Progressed From First-line EGFR-TKI Therapy
- Conditions
- Locally Advanced or Metastatic NSCLC
- Registration Number
- NCT04207775
- Lead Sponsor
- AstraZeneca
- Brief Summary
To estimate parameters associated with treatment patterns and related clinical outcomes.Including physician reported PFS and OS.
- Detailed Description
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Physician-reported clinical outcomes, PFS 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
targeted therapy 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 to initiate second line therapy from progression from 1L treatment From enrolment to follow-up of up to 36 months Time to initiate second line therapy from RECIST1.1 defined progression from 1L treatment
chemotherapy 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
immunotherapy 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
Response rate 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
Physician-reported clinical outcomes, OS 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)
local therapy 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
palliative/supportive care From enrolment to follow-up of up to 36 months Any palliative/supportive care received
- Secondary Outcome Measures
Name Time Method Molecular testing turnaround time 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
Molecular testing laboratory type 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
mutation status 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
Molecular test outcome 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
Molecular testing rate 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
Molecular test type 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
reason for molecular testing 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
Type of treatments for CNS metastases From enrolment to follow-up of up to 36 months Treatments for CNS metastases, including type of treatment
Molecular testing sample type 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
changes in testing rate over time 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
Molecular testing method of biopsy 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
reason for not performing a molecular test 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
mutation type 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 from progression date to molecular testing From enrolment to follow-up of up to 36 months Time from the RECIST defined progression date to molecular testing
histologic/phenotypic transformation 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
Brain metastases rate 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
Change in score from baseline for each QoL domain measured at each subsequent site visit 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)
Change in score from baseline for overall QoL measured at each subsequent site visit 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)
Overall CNS metastases rate 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)
Leptomeningeal metastases rate 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
Date of treatments for CNS metastases From enrolment to follow-up of up to 36 months Treatments for CNS metastases, including dates of treatment
Trial Locations
- Locations (1)
Research Site
🇨🇳Zhuji, China