Locally Advanced or Metastatic NSCLCPISCESNCT04207775
Real World Study in Locally Advanced or Metastatic NSCLC Patients, Progressed From First-line EGFR-TKI Therapy
An observational study of Locally Advanced or Metastatic NSCLC, run by AstraZeneca at 16 sites in China.
Trial summary
To estimate parameters associated with treatment patterns and related clinical outcomes.Including physician reported PFS and OS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced or Metastatic NSCLC
- How many people
- 300 participants
- Where
- 16 sitesChina
- Study dates
- 30 Mar 2020to 1 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- Involvement in the planning and/or conduct of the other intervention study
- Previous enrolment in the present study
- Pregnancy or breast-feeding
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
China16 sites
Research Site
Beijing, 101149
Research Site
Changsha, 410013
Research Site
Chengdu, 610041
Research Site
Chengdu, 610042
Research Site
Guangzhou, 510080
Research Site
Guangzhou, 510630
Research Site
Hangzhou, 310022
Research Site
Harbin, 150081
Research Site
Hohhot, 010017
Research Site
Qingdao, 266042
Research Site
Shenyang, 110044
Research Site
Suzhou, 215000
Research Site
Taizhou, 317000
Research Site
Xi'an, 710004
Research Site
Xi'an, 710032
Research Site
Zhuji
About this study
Official 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)
To estimate parameters associated with treatment patterns and related clinical outcomes.Including physician reported PFS and OS.
Read the 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
- Conditions
- Locally Advanced or Metastatic NSCLC
- Keywords
- NSCLC
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Physician-reported clinical outcomes, PFS
from date of second-line treatment initiation until progression by RECIST1.1 criteria, or death
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: From enrolment to follow-up of up to 36 months
palliative/supportive care
Any palliative/supportive care received
Measured: From enrolment to follow-up of up to 36 months
Secondary outcomes (21)
Molecular testing sample type
To estimate parameters in the target population associated with molecular testing patterns, including molecular testing sample type
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: From enrolment to follow-up of up to 36 months
Type of treatments for CNS metastases
Treatments for CNS metastases, including type of treatment
Measured: From enrolment to follow-up of up to 36 months
Date of treatments for CNS metastases
Treatments for CNS metastases, including dates of treatment
Measured: 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)
Measured: 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)
Measured: From enrolment to follow-up of up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2019
- Study start30 Mar 2020
- Primary completion1 Sep 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Locally Advanced or Metastatic NSCLCStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Weimin Li, Doctor, Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04207775
- Sponsor's protocol ID
- D5160R00031
- Acronym
- PISCES
- Status last verified
- Jul 2024
- First submitted
- 19 Dec 2019
- Last updated
- 12 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Chinese laws and regulations do not allow.
Publications
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.
PubMed 40717496
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT04207775
- Acronym / sponsor ID
- PISCES / D5160R00031
- Conditions
- Locally Advanced or Metastatic NSCLC
- Keywords
- NSCLC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 30 Mar 2020 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 23 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (8 listed)
- 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：
Key exclusion criteria (3 listed)
- Involvement in the planning and/or conduct of the other intervention study
- Previous enrolment in the present study
- Pregnancy or breast-feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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)
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
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
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
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
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
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
palliative/supportive care
Time frame: From enrolment to follow-up of up to 36 months
Any palliative/supportive care received
21 secondary outcomes
Molecular testing sample type
Time frame: From enrolment to follow-up of up to 36 months
Molecular test outcome
Time frame: From enrolment to follow-up of up to 36 months
changes in testing rate over time
Time frame: From enrolment to follow-up of up to 36 months
Molecular testing rate
Time frame: From enrolment to follow-up of up to 36 months
Time from progression date to molecular testing
Time frame: From enrolment to follow-up of up to 36 months
Molecular testing method of biopsy
Time frame: From enrolment to follow-up of up to 36 months
Molecular testing turnaround time
Time frame: From enrolment to follow-up of up to 36 months
Molecular test type
Time frame: From enrolment to follow-up of up to 36 months
reason for molecular testing
Time frame: From enrolment to follow-up of up to 36 months
Molecular testing laboratory type
Time frame: From enrolment to follow-up of up to 36 months
reason for not performing a molecular test
Time frame: From enrolment to follow-up of up to 36 months
mutation status
Time frame: From enrolment to follow-up of up to 36 months
mutation type
Time frame: From enrolment to follow-up of up to 36 months
histologic/phenotypic transformation
Time frame: From enrolment to follow-up of up to 36 months
Overall CNS metastases rate
Time frame: From enrolment to follow-up of up to 36 months
Brain metastases rate
Time frame: From enrolment to follow-up of up to 36 months
Leptomeningeal metastases rate
Time frame: From enrolment to follow-up of up to 36 months
Type of treatments for CNS metastases
Time frame: From enrolment to follow-up of up to 36 months
Date of treatments for CNS metastases
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
- Derived from this study: PubMed 40717496Tian 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.
- CSR Synopsis\_RedactedLink provided by the sponsor.
- Individual participant dataSharing planned: No. Chinese laws and regulations do not allow.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Weimin Li, Doctor principal investigator
West China Hospital
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Locally Advanced or Metastatic NSCLC, run by AstraZeneca at 16 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physician-reported clinical outcomes, PFS (time frame: From enrolment to follow-up of up to 36 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04207775, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2024.