NSCLC Stage IV Clinical Trial
Official title:
Real-world Study on Sequential Therapy With Dacomitinib as First-line Treatment Followed by 3rd Generation EGFR-TKI in Patients With EGFR Mutation Positive Advanced Non-Small Cell Lung Cancer
NCT number | NCT04768491 |
Other study ID # | NCC2439 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | September 1, 2020 |
Est. completion date | October 31, 2024 |
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 dacomitinib (Vizimpro®) as the first-line treatment followed by 3rd generation EGFR-TKI in case the T790M resistance mutation was developed.
Status | Recruiting |
Enrollment | 82 |
Est. completion date | October 31, 2024 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
China | National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking Union Medical College |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | time to treatment failure | To describe the time to treatment failure (TTF) of sequential dacomitinib and 3rd generation EGFR-TKI used in patients with EGFR mutation-positive NSCLC and T790M-aquired resistance in China. | up to 4 years | |
Secondary | progression-free survival | To describe the progression-free survival (PFS) of dacomitinib and 3rd generation EGFR-TKI used in patients with EGFR mutation-positive NSCLC with T790M-aquired resistance in China. | up to 4 years | |
Secondary | duration of treatment | To describe the duration of treatment (DOT) of dacomitinib and 3rd generation EGFR-TKI used in patients with EGFR mutation-positive NSCLC with T790M-aquired resistance respectively in China. | up to 4 years | |
Secondary | overall survival | To describe the overall survival (OS) of sequential dacomitinib and 3rd generation EGFR-TKI used in patients with EGFR mutation-positive NSCLC and T790M-aquired resistance in China. | up to 5 years |
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