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Completed

NCT Number: NCT04207775

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

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

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Beijing, China

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Physician-reported clinical outcomes, PFS

    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

  2. Physician-reported clinical outcomes, OS

    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)

  3. Time to initiate second line therapy from progression from 1L treatment

    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

  4. Response rate

    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

  5. chemotherapy

    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

  6. immunotherapy

    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

  7. targeted 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

  8. local 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

  9. palliative/supportive care

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

    Any palliative/supportive care received

Secondary outcomes

  1. 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 testing sample type

  2. Molecular test outcome

    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

  3. changes in testing rate over time

    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

  4. Molecular testing rate

    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

  5. Time from progression date to molecular testing

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

    Time from the RECIST defined progression date to molecular testing

  6. 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 method of biopsy

  7. 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 testing turnaround time

  8. 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 molecular test type

  9. 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 reason for molecular testing

  10. 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 molecular testing laboratory type

  11. 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 reason for not performing a molecular test

  12. 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 testing result of mutation status

  13. 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 molecular result of mutation type

  14. histologic/phenotypic transformation

    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

  15. Overall CNS metastases rate

    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)

  16. Brain metastases rate

    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

  17. Leptomeningeal metastases rate

    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

  18. Type of treatments for CNS metastases

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

    Treatments for CNS metastases, including type of treatment

  19. Date of treatments for CNS metastases

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

    Treatments for CNS metastases, including dates of treatment

  20. Change in score from baseline for each QoL domain measured at each subsequent site visit

    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)

  21. 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

    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)

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Dec 23, 2019
Registry last updated
Jul 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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