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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by AstraZeneca
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01955681
First received: September 30, 2013
Last updated: July 24, 2014
Last verified: July 2014
  Purpose

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


Condition
Locally Advanced or Metastatic EGFR Mutated NSCLC.

Study Type: Observational
Study Design: Time Perspective: Retrospective
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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • The treatment duration of Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor re-administration [ Time Frame: From the start of re-administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months. ] [ Designated as safety issue: No ]
    The median duration of re-administration of Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor will be summarized by days or months, if applicable. The range of this treatment duration will also be presented. All analyses will be performed on all eligible patients in this study.


Secondary Outcome Measures:
  • Assessment of progression-free survival for initial, second EGFR-TKI treatment and chemotherapy between two Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor treatments. [ Time Frame: From the start of administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months. ] [ Designated as safety issue: No ]
    The outcome of progression-free survival will be presented with median values and associated 95% CIs by Kaplan-Meier curve. PFS is defined as the time interval (in weeks) from the start date of a given treatment to the date of disease progression or death, respectively, which one is observed first. Subjects who did not progress or die without a reported progression will be censored on the date of their last tumor assessment.

  • Assessment of overall survival for initial, second EGFR-TKI treatment and chemotherapy between two Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor treatments. [ Time Frame: From the start of administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months. ] [ Designated as safety issue: No ]
    The outcome of overall survival will be presented with median values and associated 95% CIs by Kaplan-Meier curve. OS is defined as the time interval (in weeks) from the beginning of treatment until the date when death or lost to follow up is observed. For those subjects who have not died or lost to follow-up, survival duration will be censored at the last date the subject was known to be alive.

  • Assessment of response rate for initial, second EGFR-TKI treatment and chemotherapy between two Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor treatments. [ Time Frame: From the start of administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months. ] [ Designated as safety issue: No ]
    The outcome about response rate and the proportion of response rate are estimated by all evaluable patients. The 95% exact confidence interval will be constructed around the rates. The best response during treatment sequences is determined in accordance with the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines.

  • Assessment of disease control rate for initial, second EGFR-TKI treatment and chemotherapy between two Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor treatments. [ Time Frame: From the start of administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months. ] [ Designated as safety issue: No ]
    The outcome of disease control rate are estimated by all evaluable patients. The 95% exact confidence interval will be constructed around the rates. Disease Control Rate is defined as patients who are respond to treatment (including CR-complete respond, PR-partial respond or SD- Stable Disease).

  • Record treatment duration in the initial EGFR-TKI therapy and first time chemotherapy. [ Time Frame: Between the initial EGFR-TKI therapy and first time chemotherapy. ] [ Designated as safety issue: No ]
    Treatment duration in the initial EGFR-TKI therapy and first time chemotherapy.

  • Record the reason(s) for treatment change for initial and re-administration of EGFR-TKI therapy and first time chemotherapy (second-line treatment). [ Time Frame: From the start of administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months. ] [ Designated as safety issue: No ]
    Record the reason(s) for treatment change for initial and re-administration of EGFR-TKI therapy and first time chemotherapy (second-line treatment).

  • Explore relationships between efficacy of EGFR-TKI initial and re-administration and patient characteristics or EGFR TKI treatment characteristics. [ Time Frame: EGFR-TKI initial and re-administration ] [ Designated as safety issue: No ]
    Explore relationships between efficacy of EGFR-TKI initial and re-administration and patient characteristics (including demographics, histology, disease stage, sites of metastasis, ECOG PS) or EGFR TKI treatment characteristics (including EGFR mutation pattern, response to initial EGFR TKI or not, length of duration between first and second EGFR-TKI treatment)

  • overall survival (OS), plasma CEA level and chemotherapy regimens ever used. [ Time Frame: between first time chemotherapy and EGFR-TKI re-administration ] [ Designated as safety issue: No ]
    Explore overall survival (OS), plasma CEA level and chemotherapy regimens ever used between first time chemotherapy and EGFR-TKI re-administration (including the types and number of chemotherapy regimens, and treatment duration) for those patients who have the above data available.

  • image peer review to evaluate tumour size retrospectively in different sequences of treatment [ Time Frame: (1) initial and re-administration of EGFR-TKI therapy, (2) first time chemotherapy ever used (second-line treatment) after initial EGFR-TKI treatment. ] [ Designated as safety issue: No ]
    If the images are available, conduct image peer review to evaluate tumour size retrospectively in different sequences of treatment: (1) initial and re-administration of EGFR-TKI therapy, (2) first time chemotherapy ever used (second-line treatment) after initial EGFR-TKI treatment. Peer review time point includes baseline, best response and progression of last image while stopping treatment at each treatment mentioned above.

  • 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 [ Time Frame: Initial and re-administration of EGFR-TKI therapy and first time chemotherapy (second-line treatment) after peer review. ] [ Designated as safety issue: No ]
    Evaluate 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 and compare the difference of reason(s) for the treatment change between initiatial evaluation and after peer review.


Estimated Enrollment: 200
Study Start Date: December 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01955681

Contacts
Contact: Jennifer Chen 886-2737-8616 ClinicalTrialTransparency@astrazeneca.com

Locations
Taiwan
Research Site Recruiting
Kaohsiung, Taiwan
Research Site Recruiting
Taipei, Taiwan
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Yuh-Min Chen Taipei Veterans General Hospital, Taiwan
Principal Investigator: Gee-Chen Chang Veterans General Hospital -Taichung
Principal Investigator: Chong-Jen Yu National Taiwan University Hospital
Principal Investigator: Cheng-Ta Yang Chang-Gung Memorial Hospital Linkou
Principal Investigator: Te-Chun Hsia China Medical University Hospital
Principal Investigator: Meng-Chih Lin Chang-Gung Memorial Hospital Kaohsiung
Principal Investigator: Ying-Huang Tsai Chang-Gung Memorial Hospital ChiaYi
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01955681     History of Changes
Other Study ID Numbers: NIS-OTW-XXX-2013/1
Study First Received: September 30, 2013
Last Updated: July 24, 2014
Health Authority: Taiwan: Institutional Review Board

Keywords provided by AstraZeneca:
Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor retrement.

ClinicalTrials.gov processed this record on July 28, 2014