Real World Study in Locally Advanced or Metastatic NSCLC Patients, Progressed From First-line EGFR-TKI Therapy

Study Overview
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Brief Summary
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To estimate parameters associated with treatment patterns and related clinical outcomes.Including physician reported PFS and OS.

Detailed Description
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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

Official Title
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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)

Conditions
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Locally Advanced or Metastatic NSCLC

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Male or female patients with age ≥18 years old Histologically or cytologically confirmed locally advanced or metastatic NSCLC patients Patients with prior confirmed EGFR mutation-positive, who have progressed from first line EGFR-TKI* Provision of written informed consent by the patient should be within 6 weeks of the date of progression from first line EGFR-TKI treatment *Note： First-line EGFR-TKI is monotherapy; EGFR-TKI has been launched in China includes first-generation, second-generation or third-generation EGFR-TKI, but not including the original chemical compound Exclude the Chinese traditional medicine that is being used to treat lung cancer Progression was determined according to Recist1.1 criteria. Exclusion Criteria Involvement in the planning and/or conduct of the other intervention study Previous enrolment in the present study Pregnancy or breast-feeding

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NSCLC<br>Patients with confirmed EGFR mutation-positive, locally advanced or metastatic NSCLC, who have progressed from first line EGFR-TKI therapy who will receive different treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician-reported clinical outcomes, PFS | from date of second-line treatment initiation until progression by RECIST1.1 criteria, or death | From enrolment to follow-up of up to 36 months | 
| Physician-reported clinical outcomes, OS | the date of second-line treatment initiation until death from any cause(only for patients receiving 2L CT and 2L TKI, separately) | From enrolment to follow-up of up to 36 months | 
| Time to initiate second line therapy from progression from 1L treatment | Time to initiate second line therapy from RECIST1.1 defined progression from 1L treatment | From enrolment to follow-up of up to 36 months | 
| Response rate | Response rate reported by physician or judged by Recist1.1 after receiving any pattern of therapy | From enrolment to follow-up of up to 36 months | 
| chemotherapy | 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 | From enrolment to follow-up of up to 36 months | 
| immunotherapy | 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 | From enrolment to follow-up of up to 36 months | 
| targeted therapy | 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 | From enrolment to follow-up of up to 36 months | 
| local therapy | 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 | From enrolment to follow-up of up to 36 months | 
| palliative/supportive care | Any palliative/supportive care received | From enrolment to follow-up of up to 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Molecular testing sample type | To estimate parameters in the target population associated with molecular testing patterns, including molecular testing sample type | From enrolment to follow-up of up to 36 months | 
| Molecular test outcome | To estimate parameters in the target population associated with molecular testing patterns, including molecular test outcome | From enrolment to follow-up of up to 36 months | 
| changes in testing rate over time | To estimate parameters associated with molecular testing patterns, including changes in testing rate over time | From enrolment to follow-up of up to 36 months | 
| Molecular testing rate | Molecular testing rate defined as the number of patients identified as having received molecular testing divided by the number of patients | From enrolment to follow-up of up to 36 months | 
| Time from progression date to molecular testing | Time from the RECIST defined progression date to molecular testing | From enrolment to follow-up of up to 36 months | 
| Molecular testing method of biopsy | To estimate parameters in the target population associated with molecular testing patterns, including molecular testing method of biopsy | From enrolment to follow-up of up to 36 months | 
| Molecular testing turnaround time | To estimate parameters in the target population associated with molecular testing patterns, including molecular testing turnaround time | From enrolment to follow-up of up to 36 months | 
| Molecular test type | To estimate parameters in the target population associated with molecular testing patterns, including molecular test type | From enrolment to follow-up of up to 36 months | 
| reason for molecular testing | To estimate parameters in the target population associated with molecular testing patterns, including reason for molecular testing | From enrolment to follow-up of up to 36 months | 
| Molecular testing laboratory type | To estimate parameters in the target population associated with molecular testing patterns, including molecular testing laboratory type | From enrolment to follow-up of up to 36 months | 
| reason for not performing a molecular test | To estimate parameters in the target population associated with molecular testing patterns including reason for not performing a molecular test | From enrolment to follow-up of up to 36 months | 
| mutation status | To estimate parameters in the target population associated with molecular testing patterns including molecular testing result of mutation status | From enrolment to follow-up of up to 36 months | 
| mutation type | To estimate parameters in the target population associated with molecular testing patterns, including molecular result of mutation type | From enrolment to follow-up of up to 36 months | 
| histologic/phenotypic transformation | To estimate parameters in the target population associated with molecular testing patterns, including histologic/phenotypic transformation | From enrolment to follow-up of up to 36 months | 
| Overall CNS metastases rate | 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) | From enrolment to follow-up of up to 36 months | 
| Brain metastases rate | Brain metastases rate, defined as the number of patients developing brain metastases divided by the number of evaluable patients | From enrolment to follow-up of up to 36 months | 
| Leptomeningeal metastases rate | Leptomeningeal metastases rate, defined as the number of patients developing leptomeningeal metastases divided by the number of evaluable patients | From enrolment to follow-up of up to 36 months | 
| Type of treatments for CNS metastases | Treatments for CNS metastases, including type of treatment | From enrolment to follow-up of up to 36 months | 
| Date of treatments for CNS metastases | Treatments for CNS metastases, including dates of treatment | From enrolment to follow-up of up to 36 months | 
| Change in score from baseline for each QoL domain measured at each subsequent site visit | 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) | From enrolment to follow-up of up to 36 months | 
| Change in score from baseline for overall QoL measured at each subsequent site visit | 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) | From enrolment to follow-up of up to 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NSCLC