Clinical trial · Observational
Real World Study in Locally Advanced or Metastatic NSCLC Patients, Progressed From First-line EGFR-TKI Therapy
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)
NCT04207775CI-TRIAL-00078769PISCEScompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To estimate parameters associated with treatment patterns and related clinical outcomes.Including physician reported PFS and OS.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced or Metastatic NSCLC | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- NSCLC
- description
- 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
Primary outcomes (9)
- measure
- Physician-reported clinical outcomes, PFS
- timeFrame
- From enrolment to follow-up of up to 36 months
- description
- from date of second-line treatment initiation until progression by RECIST1.1 criteria, or death
- measure
- Physician-reported clinical outcomes, OS
- timeFrame
- From enrolment to follow-up of up to 36 months
- description
- the date of second-line treatment initiation until death from any cause(only for patients receiving 2L CT and 2L TKI, separately)
- measure
- Time to initiate second line therapy from progression from 1L treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDTian 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 40717496