Clinical trial NCT01955681: A Retrospective, Non-interventional, Multicenter, Observational Chart Review Study to Explore the Clinical Benefits of Retreatment With TKI in the Real World.
Official title: A Retrospective, Non-interventional Study to Evaluate EGFR-Tyrosine Kinase Inhibitor Retreatment in Patients With Locally Advanced or Metastatic EGFR Mutated NSCLC Who Previously Treated With EGFR-TKI as First-line Therapy and Chemotherapy as Second-line Therapy - SEQUENCE Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Locally Advanced or Metastatic EGFR Mutated NSCLC.
Keywords: Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor retrement.
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2013-10-07
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 150
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with locally advanced or metastatic Epidermal Growth Factor Receptor mutated Non-small-cell Lung Cancer who Previously Treated with Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor as First-line therapy and chemotherapy as second-line Therapy - SEQUENCE study

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

Detailed 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.

Eligibility 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:

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

Primary outcomes:
measure: The treatment duration of Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor re-administration
timeFrame: From the start of re-administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.
Secondary outcomes:
measure: Assessment of progression-free survival for initial, second EGFR-TKI treatment and chemotherapy between two Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor treatments.
timeFrame: From the start of administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.
measure: Assessment of overall survival for initial, second EGFR-TKI treatment and chemotherapy between two Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor treatments.
timeFrame: From the start of administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.
measure: Assessment of response rate for initial, second EGFR-TKI treatment and chemotherapy between two Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor treatments.
timeFrame: From the start of administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.
measure: Assessment of disease control rate for initial, second EGFR-TKI treatment and chemotherapy between two Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor treatments.
timeFrame: From the start of administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.
measure: Record treatment duration in the initial EGFR-TKI therapy and first time chemotherapy.
timeFrame: Between the initial EGFR-TKI therapy and first time chemotherapy.
measure: Record the reason(s) for treatment change for initial and re-administration of EGFR-TKI therapy and first time chemotherapy (second-line treatment).
timeFrame: From the start of administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.
measure: Explore relationships between efficacy of EGFR-TKI initial and re-administration and patient characteristics or EGFR TKI treatment characteristics.
timeFrame: EGFR-TKI initial and re-administration
measure: overall survival (OS), plasma CEA level and chemotherapy regimens ever used.
timeFrame: between first time chemotherapy and EGFR-TKI re-administration
measure: image peer review to evaluate tumour size retrospectively in different sequences of treatment
timeFrame: (1) initial and re-administration of EGFR-TKI therapy, (2) first time chemotherapy ever used (second-line treatment) after initial EGFR-TKI treatment.
measure: The reason(s) for the treatment change for initial and re-administration of EGFR-TKI therapy and first time chemotherapy (second-line treatment) after peer review
timeFrame: Initial and re-administration of EGFR-TKI therapy and first time chemotherapy (second-line treatment) after peer review.
Other outcomes:
Locations:
city: Chiayi
country: Taiwan
city: Kaohsiung
country: Taiwan
city: Taichung
country: Taiwan
city: Taipei
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
city: Tao Yuan
country: Taiwan
Study officials:
affiliation: Taipei Veterans General Hospital, Taiwan
name: Yuh-Min Chen
role: PRINCIPAL_INVESTIGATOR
affiliation: Veterans General Hospital -Taichung
name: Gee-Chen Chang
role: PRINCIPAL_INVESTIGATOR
affiliation: National Taiwan University Hospital
name: Chong-Jen Yu
role: PRINCIPAL_INVESTIGATOR
affiliation: Chang Gung Memorial Hospital
name: Cheng-Ta Yang
role: PRINCIPAL_INVESTIGATOR
affiliation: China Medical University Hospital
name: Te-Chun Hsia
role: PRINCIPAL_INVESTIGATOR
affiliation: Chang-Gung Memorial Hospital Kaohsiung
name: Meng-Chih Lin
role: PRINCIPAL_INVESTIGATOR
affiliation: Chang Gung Memorial Hospital, Chiayi
name: Ying-Huang Tsai
role: PRINCIPAL_INVESTIGATOR
References: