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

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)

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

Study Overview

• Status: Completed
• Conditions: Locally Advanced or Metastatic NSCLC

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

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• China
  • Beijing, China, 101149
    • Research Site
  • Changsha, China, 410013
    • Research Site
  • Chengdu, China, 610041
    • Research Site
  • Chengdu, China, 610042
    • Research Site
  • Guangzhou, China, 510080
    • Research Site
  • Guangzhou, China, 510630
    • Research Site
  • Hangzhou, China, 310022
    • Research Site
  • Harbin, China, 150081
    • Research Site
  • Hohhot, China, 010017
    • Research Site
  • Qingdao, China, 266042
    • Research Site
  • Shenyang, China, 110044
    • Research Site
  • Suzhou, China, 215000
    • Research Site
  • Taizhou, China, 317000
    • Research Site
  • Xi'an, China, 710032
    • Research Site
  • Xi'an, China, 710004
    • Research Site
  • Zhuji, China
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult male or female patients (with age ≥18 years old) who have given provision of signed and dated written informed consent by the patient or legally acceptable Patients with confirmed EGFR mutation-positive, locally advanced or metastatic NSCLC, who have progressed from first line EGFR-TKI therapy

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
NSCLC; 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?

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

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Weimin Li, Doctor, West China Hospital

Publications and helpful links

Helpful Links

• CSR Synopsis_Redacted

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2020
• Primary Completion (Actual): September 1, 2023
• Study Completion (Actual): September 1, 2023

Study Registration Dates

• First Submitted: December 19, 2019
• First Submitted That Met QC Criteria: December 19, 2019
• First Posted (Actual): December 23, 2019

Study Record Updates

• Last Update Posted (Actual): July 12, 2024
• Last Update Submitted That Met QC Criteria: July 11, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: NSCLC
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: D5160R00031

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Chinese laws and regulations do not allow.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No