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

AstraZeneca

Status: Completed

Conditions: Locally Advanced or Metastatic NSCLC

Study type: Observational

Funder types: Industry

Identifiers

NCT04207775

D5160R00031

Details and patient eligibility

About

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

Full 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

Enrollment: 300 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

300 participants in 1 patient group

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