EGFRNCT05663177
Almonertinib Plus Metronomic Oral Vinorelbine
An observational study of EGFR and NSCLC, run by Fujian Cancer Hospital.
Trial summary
To evaluate the efficacy of continuing osimertinib in conjunction with metronomic oral vinorelbine after limited progression on osimertinib, to provide clinical experience on the treatment strategy for these patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- EGFR, NSCLC, Third-generation TKI
- What is being tested?
- Almonertinib and metronomic oral vinorelbine
- Type of treatment
- Pill or oral medicine
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 20 Dec 2022to 1 Jun 2024
- How long will I take part?
- 3 Years
- 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: EGFR-mutant advanced NSCLC, disease progression on the third-generation TKI
Who may be able to join
- Non-small cell lung cancer diagnosed by histopathology or cytology;
- Previous molecular pathology was EGFR sensitive mutation;
- Stage IV;
- ECOG score 0-2;
- Prior to receiving the third generation of EGFR-TKI targeted therapy, and TKI targeted therapy showed limited progress;
- According to RECIST1.1 standards, there are measurable or evaluable lesions
- The patient has fully understood this study and voluntarily signed a written informed consent form;
- The estimated survival time is more than 3 months.
Who cannot join
- Histological or cytological confirmation of small cell lung cancer or squamous cell carcinoma at the first diagnosis;
- The progression of the third generation EGFR-TKI suggests histological transformation.
About this study
Official title: Almonertinib Plus Metronomic Oral Vinorelbine Beyond Limited Progression on Third-generation TKI in EGFR-mutant Advanced NSCLC，an Observational Study
To evaluate the efficacy of continuing osimertinib in conjunction with metronomic oral vinorelbine after limited progression on osimertinib, to provide clinical experience on the treatment strategy for these patients.
Read the detailed description
This study is a clinical observation study. The patients who comfirm the criteria will be treated with Almonertinib plus metronomic oral vinorelbine. The patients will be followed up until the tumor progressed, and the efficacy (PFS, ORR, DCR) of tumor therapy were evaluated.
Drug administration regimen: Ametinib 110mg once a day; Oral Vinorelbine 40mg three times a week for three weeks and Q28d for one course.
- Conditions
- EGFR, NSCLC, Third-generation TKI
- Being tested
- Almonertinib and metronomic oral vinorelbine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Almonertinib and metronomic oral vinorelbineDrug
Ametinib 110mg once a day; Oral Vinorelbine 40mg three times a week for three weeks and Q28d for one course.
| Study group | Role | What they receive |
|---|---|---|
| Study arm | Almonertinib plus metronomic oral vinorelbine Receives: Drug: Almonertinib and metronomic oral vinorelbine |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
progression-free survival
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Secondary outcomes (2)
ORR
Objective Response Rate
Measured: up to 12 months
DCR
Disease Control Rate
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2022
- Study start20 Dec 2022 (estimated)
- Primary completion20 Dec 2023 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EGFRStudies of the same condition, open and under way.
- More trials run by Fujian Cancer HospitalThe sponsor's other registered studies.
- 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
- 40 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05663177
- Sponsor's protocol ID
- SCOG005
- Status last verified
- Dec 2022
- First submitted
- 6 Dec 2022
- Last updated
- 23 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Almonertinib Plus Metronomic Oral Vinorelbine Beyond Limited Progression on Third-generation TKI in EGFR-mutant Advanced NSCLC，an Observational Study
- ClinicalTrials.gov ID
- NCT05663177
- Acronym / sponsor ID
- SCOG005
- Conditions
- EGFR, NSCLC, Third-generation TKI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Study start
- 20 Dec 2022 (estimated)
- Primary completion
- 20 Dec 2023 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 23 Dec 2022 (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.
To evaluate the efficacy of continuing osimertinib in conjunction with metronomic oral vinorelbine after limited progression on osimertinib, to provide clinical experience on the treatment strategy for these patients.
Detailed description
This study is a clinical observation study. The patients who comfirm the criteria will be treated with Almonertinib plus metronomic oral vinorelbine. The patients will be followed up until the tumor progressed, and the efficacy (PFS, ORR, DCR) of tumor therapy were evaluated.
Drug administration regimen: Ametinib 110mg once a day; Oral Vinorelbine 40mg three times a week for three weeks and Q28d for one course.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study arm | – | Drug: Almonertinib and metronomic oral vinorelbineAlmonertinib plus metronomic oral vinorelbine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- EGFR-mutant advanced NSCLC, disease progression on the third-generation TKI
Key inclusion criteria (8 listed)
- Non-small cell lung cancer diagnosed by histopathology or cytology;
- Previous molecular pathology was EGFR sensitive mutation;
- Stage IV;
- ECOG score 0-2;
- Prior to receiving the third generation of EGFR-TKI targeted therapy, and TKI targeted therapy showed limited progress;
Key exclusion criteria (2 listed)
- Histological or cytological confirmation of small cell lung cancer or squamous cell carcinoma at the first diagnosis;
- The progression of the third generation EGFR-TKI suggests histological transformation.
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 |
|---|---|---|
| Almonertinib and metronomic oral vinorelbineAmetinib 110mg once a day; Oral Vinorelbine 40mg three times a week for three weeks and Q28d for one course. | Drug | Study arm |
Primary outcome
PFS
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
progression-free survival
2 secondary outcomes
ORR
Time frame: up to 12 months
DCR
Time frame: up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2022.
- Individual participant dataSharing planned: No
Related trials for EGFR
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Recruiting
Short-Term Reduced Dietary Protein in ER+/HER2- Breast Cancer Patients During Neoadjuvant Chemotherapy
Breast Cancer, Hormone Receptor Positive / HER2-negative Breast Cancer
RecruitingPhase 3
Adding an Immunotherapy Drug, MEDI4736 (Durvalumab), to the Usual Chemotherapy Treatment (Paclitaxel, Cyclophosphamide, and Doxorubicin) for Stage II-III Breast Cancer
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8
RecruitingPhase 1/2
A Study of VRN110755 in Patients With EGFR-Mutant Non-Small Cell Lung Cancer
EGFR-Mutant Non-Small Cell Lung Cancer
Not yet recruitingObservational study
Beta-2-Trace Protein in Diabetic Nephropathy
Diabetic Nephropathy Type 2, Type 2 Diabetes Mellitus
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of EGFR and NSCLC, run by Fujian Cancer Hospital.
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 8 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 23 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months). 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 23 Dec 2022.