A Retrospective, Non-interventional, Multicenter, Observational Chart Review Study to Explore the Clinical Benefits of Retreatment With TKI in the Real World. (SEQUENCE)

AstraZeneca

Status: Completed

Conditions: Locally Advanced or Metastatic EGFR Mutated NSCLC.

Study type: Observational

Funder types: Industry

Identifiers

NCT01955681

NIS-OTW-XXX-2013/1

Details and patient eligibility

About

This is a retrospective, non-interventional, multicenter, observational chart review study to explore the clinical benefits of retreatment with TKI in the real world.

Full description

This study is designed to retrospectively review the medical and chemotherapy records of 300 patients with EGFR mutation positive adenocarcinoma NSCLC. Eligible patients are as follows: histologically or cytologically confirmed NSCLC, undergone EGFR-TKI retreatment sometime after the failure of the initial EGFR-TKI. After initial treatment, patients had been treated with chemotherapy and subsequently re-treated with EGFR-TKI will be identified. The target population will be derived from multicentre in Taiwan. The study aim is to evaluate clinical effect in re-administration of EGFR-TKI using retrospectively collected data from these eligible patients to provide valuable information.

Enrollment: 200 estimated patients

Sex: All

Ages: 20 to 150 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

1. Patients diagnosed with advanced adenocarcinoma or positive result of thyroid transcription factor 1 NSCLC

2. Positive Epidermal Growth Factor Receptor mutation result with sensitive mutation

3. Female or male aged ≧20 years

4. Patients treated with Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor and subsequently treated with chemotherapy before re-administration of Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor. Exclusion Criteria:

5. Patients with EGFR mutation status of positive exon 20 T790M mutation only. 2. Patients who are confirmed of squamous type NSCLC