Non Small Cell Lung CancerNCT03647592
Real World Study on Erlotinib/Gefitinib Combined With Bevacizumab in Advanced Non-aquamous Non-small Cell Lung Cancer
An observational study of Non Small Cell Lung Cancer, run by Hunan Province Tumor Hospital at 1 site in China.
Trial summary
This study aims to explore the efficacy and safety of Erlotinib/Gefitinib combined with bevacizumab in the real world for advanced non-squamous cell lung cancer with EGFR mutation, explore new drug resistance mechanisms under the A+T regimen and consistency between plasma and tissue detection driving genes, and… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Erlotinib/Gefitinib combined with Bevacizumab
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2018to 1 Dec 2025
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 30 non-saquamous non-small cell lung cancer with EGFR mutation positive (19del/L858R) were inrolled in this study. ECOG PS 0-1 All the patients recieved the treatment of erlotinib combined with Bevacizumab.
Who may be able to join
- EGFR mutation(19del/L858R)
- advanced non-saquamous non-small cell lung cancer
- primary treatment of first diagnosis
- performance status（0-1)
Who cannot join
- other genes mutation
- saquamous
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hunan Provincal Tumor Hospital
Changsha, Hunan, 410013
Nong Yang, MD, +86 731 89762323, yangnong0217@163.com
Chunhua Zhou, MD, +86 731 89762321, zhouchunhua@hnszlyy.com
About this study
Official title: Real World Study to Evaluate the Efficacy and Resistant Mechanism of Erlotinib/Gefitinib Combined With Bevacizumab in First Line EGFR Mutation Positive Advanced Non-aquamous Non-small Cell Lung Cancer
This study aims to explore the efficacy and safety of Erlotinib/Gefitinib combined with bevacizumab in the real world for advanced non-squamous cell lung cancer with EGFR mutation, explore new drug resistance mechanisms under the A+T regimen and consistency between plasma and tissue detection driving genes, and finally assess the predictive value of plasma dynamic detection driving gene mutation profiles in predicting disease. The role of disease progression risk.
Read the detailed description
A retrospective study of 30 cases of advanced non-squamous non-small cell lung cancer (NSCLC) with EGFR mutation positive treated with A+T was conducted to observe the efficacy and safety of A+T regimen in the real world. Exploratory research contents are as follows: 1. Consistency between tissue gene test (NGS) and plasma gene test (NGS) at the initial diagnosis; 2. Consistency between tissue gene test (NGS) and plasma gene test (NGS) at the progression of A + T treatment; 3. New drug resistance mechanism of A + T treatment; 4. Plasma dynamics during A + T treatment. Detection (the first efficacy evaluation and a blood sampling before imaging PD) exploration and imaging progress sequence; 5. Plasma large panel dynamic drive gene mutation spectrum analysis to build disease progression risk model.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Erlotinib/Gefitinib combined with Bevacizumab
- Keywords
- Non-small Cell Lung Cancer, Bevacizumab, Erlotinib/Gefitinib, EGFR mutation positive
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erlotinib/Gefitinib combined with BevacizumabDrug
Also called treatment of A+T
Erlotlnib,150mg po qd/gefitinib 250mg po qd +Bevacizumab(15mg/kg),lvgtt,every 21 day ,evaluate every 2 months
| Study group | Role | What they receive |
|---|---|---|
| Cohorts 1 | patients with EGFR mutation-positive who received treatment of Erlotinib/Gefitinib Combined With Bevacizumab Receives: Drug: Erlotinib/Gefitinib combined with Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Progression free survival
Measured: Approximately 1 years
Secondary outcomes (2)
OS
Overall survival
Measured: Approximately 1 years
DCR
Disease control rate
Measured: Approximately 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2018
- Study start1 Jun 2018
- Primary completion31 Aug 2024 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies 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
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hunan Province Tumor Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongchang Zhang, Hunan Province Tumor Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03647592
- Sponsor's protocol ID
- WECAN
- Status last verified
- Dec 2023
- First submitted
- 23 Aug 2018
- Last updated
- 27 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Study to Evaluate the Efficacy and Resistant Mechanism of Erlotinib/Gefitinib Combined With Bevacizumab in First Line EGFR Mutation Positive Advanced Non-aquamous Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT03647592
- Acronym / sponsor ID
- WECAN
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- Non-small Cell Lung Cancer, Bevacizumab, Erlotinib/Gefitinib, EGFR mutation positive
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hunan Province Tumor HospitalUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 27 Aug 2018 (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 study aims to explore the efficacy and safety of Erlotinib/Gefitinib combined with bevacizumab in the real world for advanced non-squamous cell lung cancer with EGFR mutation, explore new drug resistance mechanisms under the A+T regimen and consistency between plasma and tissue detection driving genes, and finally assess the predictive value of plasma dynamic detection driving gene mutation profiles in predicting disease. The role of disease progression risk.
Detailed description
A retrospective study of 30 cases of advanced non-squamous non-small cell lung cancer (NSCLC) with EGFR mutation positive treated with A+T was conducted to observe the efficacy and safety of A+T regimen in the real world. Exploratory research contents are as follows: 1. Consistency between tissue gene test (NGS) and plasma gene test (NGS) at the initial diagnosis; 2. Consistency between tissue gene test (NGS) and plasma gene test (NGS) at the progression of A + T treatment; 3. New drug resistance mechanism of A + T treatment; 4. Plasma dynamics during A + T treatment. Detection (the first efficacy evaluation and a blood sampling before imaging PD) exploration and imaging progress sequence; 5. Plasma large panel dynamic drive gene mutation spectrum analysis to build disease progression risk model.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohorts 1 | – | Drug: Erlotinib/Gefitinib combined with Bevacizumabpatients with EGFR mutation-positive who received treatment of Erlotinib/Gefitinib Combined With Bevacizumab |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 30 non-saquamous non-small cell lung cancer with EGFR mutation positive (19del/L858R) were inrolled in this study. ECOG PS 0-1 All the patients recieved the treatment of erlotinib combined with Bevacizumab.
Key inclusion criteria (4 listed)
- EGFR mutation(19del/L858R)
- advanced non-saquamous non-small cell lung cancer
- primary treatment of first diagnosis
- performance status（0-1)
Key exclusion criteria (2 listed)
- other genes mutation
- saquamous
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 |
|---|---|---|
| Erlotinib/Gefitinib combined with BevacizumabAlso: treatment of A+TErlotlnib,150mg po qd/gefitinib 250mg po qd +Bevacizumab(15mg/kg),lvgtt,every 21 day ,evaluate every 2 months | Drug | Cohorts 1 |
Primary outcome
PFS
Time frame: Approximately 1 years
Progression free survival
2 secondary outcomes
OS
Time frame: Approximately 1 years
DCR
Time frame: Approximately 1 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2023.
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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.
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 Non Small Cell Lung Cancer, run by Hunan Province Tumor Hospital 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 4 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 27 Dec 2023. 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 Yongchang Z MD, MD (+8613873123436 ext. 7+861383123436, zhangyongchang@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: Approximately 1 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 27 Dec 2023.