Status:
UNKNOWN
Dacomitinib Treatment Followed by 3rd Generation EGFR-TKI in Patients With EGFR Mutation Positive Advanced NSCLC
Lead Sponsor:
Peking Union Medical College
Conditions:
EGFR Activating Mutation
NSCLC Stage IV
Eligibility:
All Genders
18+ years
Brief Summary
This is a non-interventional, multi-center, ambispective cohort study in real world to describe the effectiveness and safety profile in patients with EGFR mutation-positive advanced NSCLC treated with...
Detailed Description
This is a multi-center observational study with both retrospective and prospective data collections to describe the effectiveness and safety of sequential dacomitinib and 3rd generation EGFR-TKI used ...
Eligibility Criteria
Inclusion
- A confirmed diagnosis of locally advanced or metastatic NSCLC.
- The tumor harbored common EGFR mutations (Del19, L858R) at start of first-line treatment
- Age ≥ 18 years
- Had never received any EGFR TKI therapy.
- Patients that treated with dacomitinib (Vizimpro®) as first-line treatment
- Confirmation of the T790M variant after first line dacomitinib treatment and receive any 3rd generation EGFR-TKI as second-line treatment.
- Asymptomatic CNS metastases allowed
- At least one lesion that can be accurately measured at baseline according to the RECIST 1.1, and which is suitable for accurate repeated measurements.
- Start second-line treatment with third generation EGFR TKI no later than 01 JAN2023（\>10 month before data cutoff date）
- All eligible patients are required to sign an informed consent before initiating the study
Exclusion
- Patients who received drug(s) other than 3rd generation EGFR-TKI as the second-line treatment and/or patients who received drug(s) other than Dacomitinib (Vizimpro®) as the first-line treatment
- Received or currently receiving dacomitinib from any interventional clinical trial
Key Trial Info
Start Date :
September 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 31 2024
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT04768491
Start Date
September 1 2020
End Date
October 31 2024
Last Update
February 24 2021
Active Locations (1)
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1
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China, 100021