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)
1 other identifier
observational
300
1 country
16
Brief Summary
To estimate parameters associated with treatment patterns and related clinical outcomes.Including physician reported PFS and OS.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2020
Typical duration for all trials
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 19, 2019
CompletedFirst Posted
Study publicly available on registry
December 23, 2019
CompletedStudy Start
First participant enrolled
March 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2023
CompletedJuly 12, 2024
July 1, 2024
3.4 years
December 19, 2019
July 11, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (9)
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 Outcomes (21)
Molecular testing sample type
From enrolment to follow-up of up to 36 months
Molecular test outcome
From enrolment to follow-up of up to 36 months
changes in testing rate over time
From enrolment to follow-up of up to 36 months
Molecular testing rate
From enrolment to follow-up of up to 36 months
Time from progression date to molecular testing
From enrolment to follow-up of up to 36 months
- +16 more secondary outcomes
Study Arms (1)
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
Eligibility Criteria
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
You may qualify if:
- 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.
You may not qualify if:
- Involvement in the planning and/or conduct of the other intervention study
- Previous enrolment in the present study
- Pregnancy or breast-feeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (16)
Research Site
Beijing, 101149, China
Research Site
Changsha, 410013, China
Research Site
Chengdu, 610041, China
Research Site
Chengdu, 610042, China
Research Site
Guangzhou, 510080, China
Research Site
Guangzhou, 510630, China
Research Site
Hangzhou, 310022, China
Research Site
Harbin, 150081, China
Research Site
Hohhot, 010017, China
Research Site
Qingdao, 266042, China
Research Site
Shenyang, 110044, China
Research Site
Suzhou, 215000, China
Research Site
Taizhou, 317000, China
Research Site
Xi'an, 710004, China
Research Site
Xi'an, 710032, China
Research Site
Zhuji, China
Related Publications (1)
Tian P, Wu L, Zhou C, Tan J, Wang K, Luo F, Liu Y, Guo Y, Li Y, Liu Z, Gong Y, Wang Y, Xian J, Li W. Molecular testing, treatment patterns, and outcomes in EGFR-mutated non-small cell lung cancer: the PISCES study. Future Oncol. 2025 Aug;21(19):2537-2547. doi: 10.1080/14796694.2025.2529094. Epub 2025 Jul 28.
PMID: 40717496DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Weimin Li, Doctor
West China Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 19, 2019
First Posted
December 23, 2019
Study Start
March 30, 2020
Primary Completion
September 1, 2023
Study Completion
September 1, 2023
Last Updated
July 12, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share
Chinese laws and regulations do not allow.