Locally Advanced or Metastatic NSCLC
Conditions
Keywords
NSCLC
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
Interventions
None listed
Sponsors
AstraZeneca
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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) |
| 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 |
| 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 |
| 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 |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 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 |
| 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 |
| 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 |
| 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) |
| 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 |
| 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 |
| Type of treatments for CNS metastases | From enrolment to follow-up of up to 36 months | Treatments for CNS metastases, including type of treatment |
| Date of treatments for CNS metastases | From enrolment to follow-up of up to 36 months | Treatments for CNS metastases, including dates of treatment |
| 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) |
| 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 |
| 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 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 |
| 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 |
| 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 |
| 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 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 |
Countries
China
Outcome results
None listed