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Report for Clinical Trial NCT01955681

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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

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

NCT01955681 Locally Advanced or Metastatic EGFR Mutated NSCLC.


Primary Outcomes

Description: 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.

Measure: The treatment duration of Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor re-administration

Time: From the start of re-administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.

Secondary Outcomes

Description: 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.

Measure: Assessment of progression-free survival for initial, second EGFR-TKI treatment and chemotherapy between two Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor treatments.

Time: From the start of administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.

Description: 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.

Measure: Assessment of overall survival for initial, second EGFR-TKI treatment and chemotherapy between two Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor treatments.

Time: From the start of administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.

Description: 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.

Measure: Assessment of response rate for initial, second EGFR-TKI treatment and chemotherapy between two Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor treatments.

Time: From the start of administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.

Description: 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).

Measure: Assessment of disease control rate for initial, second EGFR-TKI treatment and chemotherapy between two Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor treatments.

Time: From the start of administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.

Description: Treatment duration in the initial EGFR-TKI therapy and first time chemotherapy.

Measure: Record treatment duration in the initial EGFR-TKI therapy and first time chemotherapy.

Time: Between the initial EGFR-TKI therapy and first time chemotherapy.

Description: Record the reason(s) for treatment change for initial and re-administration of EGFR-TKI therapy and first time chemotherapy (second-line treatment).

Measure: Record the reason(s) for treatment change for initial and re-administration of EGFR-TKI therapy and first time chemotherapy (second-line treatment).

Time: From the start of administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.

Description: 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)

Measure: Explore relationships between efficacy of EGFR-TKI initial and re-administration and patient characteristics or EGFR TKI treatment characteristics.

Time: EGFR-TKI initial and re-administration

Description: 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.

Measure: overall survival (OS), plasma CEA level and chemotherapy regimens ever used.

Time: between first time chemotherapy and EGFR-TKI re-administration

Description: 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.

Measure: image peer review to evaluate tumour size retrospectively in different sequences of treatment

Time: (1) initial and re-administration of EGFR-TKI therapy, (2) first time chemotherapy ever used (second-line treatment) after initial EGFR-TKI treatment.

Description: 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.

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

Time: Initial and re-administration of EGFR-TKI therapy and first time chemotherapy (second-line treatment) after peer review.

Time Perspective: Retrospective


There is one SNP

SNPs


1 T790M

Exclusion Criteria: 1. Patients with EGFR mutation status of positive exon 20 T790M mutation only. --- T790M ---



HPO Nodes