Non Small Cell Lung Cancerpre-FLAMENCT06422546
A Prospective, Multicenter, Non-interventional, Real-world Study to Characterize Changes in Molecular Markers After Three Weeks of Targeted Therapy With Oxitinib in EGFRm NSCLC
An observational study of Non Small Cell Lung Cancer, run by Beijing Cancer Prevention & Treatment Society at 1 site in China.
Trial summary
To evaluate the characteristics of genetic variationmutations at baseline and 3 weeks after oxitinib treatment in EGFRm NSCLC Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- How many people
- 950 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2022to 15 Jun 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: stage IV metastatic or recurrent non-squamous EGFR-positive NSCLC
Who may be able to join
- ≥18 years old male or female
- Stage IV metastatic or recurrent non-squamous NSCLC that is newly diagnosed, histologically proven and not suitable for radical surgery or radiotherapy (AJCC V8);
- Without prior systemic antitumor therapy including EGFR-TKI or immunotherapy;
- EGFR positive in blood or tissue tested in local laboratory;
- Sufficient blood samples can be provided for molecular detection;
- Signed informed consent forms are available.
Who cannot join
- Patients were unable to collect plasma samples at baseline;
- The EGFR mutant status of the patient's blood specimen at baseline has not been verified by the central laboratory;
- The patient refused subsequent treatment with oxitinib; 4）The investigator determines that may affect the conduct of the clinical study and the judgement of the study results.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Prevention society
Beijing, Beijing Municipality, 100021
Qu Liudi, 18519773872, qld@bcpts.org.cn
Du Xueying, 18811792675, xueying.du@halmaorient.com
About this study
Official title: A Prospective, Multicenter, Non-interventional, Real-world Study to Characterize Changes in Molecular Markers After Three Weeks of Targeted Therapy With Oxitinib in Chinese Patients With Stage IV Metastatic or Recurrent Non-squamous EGFR-positive NSCLC
To evaluate the characteristics of genetic variationmutations at baseline and 3 weeks after oxitinib treatment in EGFRm NSCLC
Read the detailed description
Characteristics of EGFR gene mutation and efficacy of oxitinib treatment at baseline and after 3 weeks of treatment.To evaluate the mechanism of oxitinib treatment resistance and describe the characteristics of genetic variation associated with oxitinib treatment at baseline and 3 weeks after treatment.
- Conditions
- Non Small Cell Lung Cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in EGFR gene mutations
To characterize the changes in EGFR gene mutations at baseline and 3 weeks after oxitinib treatment
Measured: baseline and 3 weeks after oxitinib treatment
Secondary outcomes (1)
Characteristics of EGFR gene mutation and efficacy of oxitinib treatment
Characteristics of EGFR gene mutation and efficacy of oxitinib treatment at baseline and after 3 weeks of treatment
Measured: baseline and 3 weeks after oxitinib treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2024
- Study start15 Jan 2022
- Primary completion31 Jul 2024 (estimated)
- Study completion15 Jun 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 950 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Cancer Prevention & Treatment Society
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06422546
- Sponsor's protocol ID
- pre-FLAME
- Acronym
- pre-FLAME
- Status last verified
- May 2024
- First submitted
- 15 May 2024
- Last updated
- 21 May 2024
- 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 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Non-interventional, Real-world Study to Characterize Changes in Molecular Markers After Three Weeks of Targeted Therapy With Oxitinib in Chinese Patients With Stage IV Metastatic or Recurrent Non-squamous EGFR-positive NSCLC
- ClinicalTrials.gov ID
- NCT06422546
- Acronym / sponsor ID
- pre-FLAME / pre-FLAME
- Conditions
- Non Small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 950 participants (estimated)
- Lead sponsor
- Beijing Cancer Prevention & Treatment SocietyUniversity, hospital or other
- Collaborators
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Study start
- 15 Jan 2022 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 15 Jun 2025 (estimated)
- First posted
- 21 May 2024 (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 characteristics of genetic variationmutations at baseline and 3 weeks after oxitinib treatment in EGFRm NSCLC
Detailed description
Characteristics of EGFR gene mutation and efficacy of oxitinib treatment at baseline and after 3 weeks of treatment.To evaluate the mechanism of oxitinib treatment resistance and describe the characteristics of genetic variation associated with oxitinib treatment at baseline and 3 weeks after treatment.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- stage IV metastatic or recurrent non-squamous EGFR-positive NSCLC
Key inclusion criteria (6 listed)
- ≥18 years old male or female
- Stage IV metastatic or recurrent non-squamous NSCLC that is newly diagnosed, histologically proven and not suitable for radical surgery or radiotherapy (AJCC V8);
- Without prior systemic antitumor therapy including EGFR-TKI or immunotherapy;
- EGFR positive in blood or tissue tested in local laboratory;
- Sufficient blood samples can be provided for molecular detection;
Key exclusion criteria (3 listed)
- Patients were unable to collect plasma samples at baseline;
- The EGFR mutant status of the patient's blood specimen at baseline has not been verified by the central laboratory;
- The patient refused subsequent treatment with oxitinib; 4）The investigator determines that may affect the conduct of the clinical study and the judgement of the study results.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
changes in EGFR gene mutations
Time frame: baseline and 3 weeks after oxitinib treatment
To characterize the changes in EGFR gene mutations at baseline and 3 weeks after oxitinib treatment
1 secondary outcome
Characteristics of EGFR gene mutation and efficacy of oxitinib treatment
Time frame: baseline and 3 weeks after oxitinib treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- 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.
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 Beijing Cancer Prevention & Treatment Society 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 6 inclusion and 3 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 21 May 2024. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in EGFR gene mutations (time frame: baseline and 3 weeks after oxitinib treatment). 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 21 May 2024.