EGFR Activating MutationNCT04768491
Dacomitinib Treatment Followed by 3rd Generation EGFR-TKI in Patients With EGFR Mutation Positive Advanced NSCLC
An observational study of EGFR Activating Mutation and NSCLC Stage IV, run by Peking Union Medical College at 1 site in China.
Trial 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 dacomitinib (Vizimpro®) as the first-line treatment followed by 3rd generation EGFR-TKI in case the T790M resistance… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- EGFR Activating Mutation, NSCLC Stage IV, NSCLC Stage IIIB
- What is being tested?
- Dacomitinib
- How many people
- 82 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2020to 31 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with EGFR mutation and advanced NSCLC
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, 100021
Dawei Wu, PhD, +86-10-877888495
About this study
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
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.
Read the 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 in patients with EGFR mutation-positive NSCLC with T790M-aquired resistance in a clinical practice setting. The study will include patients who were or will be diagnosed as advanced NSCLC with EGFR mutation positive and received dacomitinib as first-line treatment followed by second-line 3rd generation EGFR-TKI treatment in multiple tertiary care hospitals after Sep 1st, 2019. Patients' clinical information prior to the study initiation in each hospital will be collected retrospectively through chart review. After the study initiation, new patient enrollment will last till Dec 2022. Patients' clinical care after the study initiation will be followed up prospectively until the end of study. The interval of response evaluation is recommended to be every 2 to 3 months in the treatment period and the interval of follow-up is recommended to be every 2 to 3 months in the post-treatment period till the end of study in the prospective data collection period.
- Being tested
- Dacomitinib
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DacomitinibDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| dacomitinib treatment | 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 Receives: Drug: Dacomitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 4 years
Secondary outcomes (3)
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.
Measured: up to 4 years
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.
Measured: up to 4 years
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.
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2021
- Study start1 Sep 2020
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EGFR Activating MutationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junling Li, Peking Union Medical College
- Investigators
- Junling Li, MD, Study director, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04768491
- Sponsor's protocol ID
- NCC2439
- Status last verified
- Feb 2021
- First submitted
- 18 Feb 2021
- Last updated
- 24 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04768491
- Acronym / sponsor ID
- NCC2439
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Peking Union Medical CollegeUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 24 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 in patients with EGFR mutation-positive NSCLC with T790M-aquired resistance in a clinical practice setting. The study will include patients who were or will be diagnosed as advanced NSCLC with EGFR mutation positive and received dacomitinib as first-line treatment followed by second-line 3rd generation EGFR-TKI treatment in multiple tertiary care hospitals after Sep 1st, 2019. Patients' clinical information prior to the study initiation in each hospital will be collected retrospectively through chart review. After the study initiation, new patient enrollment will last till Dec 2022. Patients' clinical care after the study initiation will be followed up prospectively until the end of study. The interval of response evaluation is recommended to be every 2 to 3 months in the treatment period and the interval of follow-up is recommended to be every 2 to 3 months in the post-treatment period till the end of study in the prospective data collection period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dacomitinib treatment | – | Drug: DacomitinibSequential 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with EGFR mutation and advanced NSCLC
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dacomitinibeffectiveness 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. | Drug | dacomitinib treatment |
Primary outcome
time to treatment failure
Time frame: up to 4 years
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.
3 secondary outcomes
progression-free survival
Time frame: up to 4 years
duration of treatment
Time frame: up to 4 years
overall survival
Time frame: up to 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Junling Li, MD study director
Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of EGFR Activating Mutation and NSCLC Stage IV, run by Peking Union Medical College at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Puyuan Xing, PhD (+86-10-87788495, xingpuyuan@cicams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to treatment failure (time frame: up to 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2021.