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

N/ACompletedNCT04207775

AstraZeneca300 enrolled

Overview

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

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

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

Locally Advanced or Metastatic NSCLC

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria 1. Male or female patients with age ≥18 years old 2. Histologically or cytologically confirmed locally advanced or metastatic NSCLC patients 3. Patients with prior confirmed EGFR mutation-positive, who have progressed from first line EGFR-TKI\* 4. 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： 1. First-line EGFR-TKI is monotherapy; 2. EGFR-TKI has been launched in China includes first-generation, second-generation or third-generation EGFR-TKI, but not including the original chemical compound 3. Exclude the Chinese traditional medicine that is being used to treat lung cancer 4. Progression was determined according to Recist1.1 criteria. Exclusion Criteria 1. Involvement in the planning and/or conduct of the other intervention study 2. Previous enrolment in the present study 3. Pregnancy or breast-feeding

Locations (16)

Research Site

Beijing, China

Research Site

Changsha, China

Research Site

Chengdu, China

Outcomes

Primary Outcomes

Physician-reported clinical outcomes, PFS

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

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)

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Secondary Outcomes

Molecular testing sample type

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

Molecular test outcome

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

changes in testing rate over time

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

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 progression date to molecular testing

Time from the RECIST defined progression date to molecular testing

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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)

Time frame: 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

Time frame: 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

Time frame: From enrolment to follow-up of up to 36 months

Type of treatments for CNS metastases

Treatments for CNS metastases, including type of treatment

Time frame: From enrolment to follow-up of up to 36 months

Date of treatments for CNS metastases

Treatments for CNS metastases, including dates of treatment

Time frame: 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)

Time frame: From enrolment to follow-up of up to 36 months

Change in score from baseline for overall QoL measured at each subsequent site visit

Time frame: From enrolment to follow-up of up to 36 months