Non Small Cell Lung Cancerpre-FLAMENCT06422546
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy 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
A prospective ,multicenter ,non-interventional ,real-world study observing changes in molecular markers after three weeks of osimertinib targeted therapy 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
- 28 Dec 2021to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 IIIB,IIIC,IV or recurrent NSCLC
Who may be able to join
- Male or female,age ≥18 years.
- Newly diagnosed,histologically confirmed,and classified as stage IIIB,IIIC,IV or recurrent NSCLC which are not amenable to curative surgery or radiotherapy .
- No prior systemic antitumor therapy, including EGFR -TKIs or immunotherapy .
- Presence of an EGFR mutation confirmed by a local laboratory in blood or tissue samples .
- Adequate blood samples available for molecular testing .
- Provision of written informed consent .
Who cannot join
- Inability to provide plasma samples at baseline .
- Baseline blood EGFR mutation status not confirmed by the central laboratory .
- Refusal to receive subsequent treatment with osimertinib .
- Any condition that ,in the investigator's judgment ,could interfere with study procedures or confound outcome assessment .
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital Chinese
Beijing
Jie Wang, 13910704669, zlhuxi@163.com
About this study
Official title: A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers After Three Weeks of Osimertinib Targeted Therapy in Chinese Patients With Stage IIIB ,IIIC ,or IV Metastatic or Recurrent Non Squamous EGFR-positive Non-small Cell Lung Cancer
A prospective ,multicenter ,non-interventional ,real-world study observing changes in molecular markers after three weeks of osimertinib targeted therapy in EGFRm NSCLC
Read the detailed description
A prospective ,multicenter ,non-interventional ,real-world study observing changes in molecular markers after three weeks of osimertinib targeted therapy in Chinese patients with stage IIIB ,IIIC ,or IV metastatic or recurrent non squamous EGFR-positive non-small cell lung cancer
- 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.
describe the characteristics of EGFR mutations changes
To describe the characteristics of EGFR mutations changes at baseline and after three weeks of osimertinib treatment
Measured: baseline and after three weeks of osimertinib treatment
Secondary outcomes (1)
Characteristics of EGFR gene mutation and efficacy of oxitinib treatment
To evaluate the changes in EGFR mutations at baseline and after 3weeks treatment,and their correlation with the therapeutic efficacy of osimertinib .
Measured: baseline and after three weeks of osimertinib 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 start28 Dec 2021
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (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
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06422546
- Sponsor's protocol ID
- pre-FLAME
- Acronym
- pre-FLAME
- Status last verified
- Oct 2026
- First submitted
- 15 May 2024
- Last updated
- 2 Nov 2026
- 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 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers After Three Weeks of Osimertinib Targeted Therapy in Chinese Patients With Stage IIIB ,IIIC ,or IV Metastatic or Recurrent Non Squamous EGFR-positive Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06422546
- Acronym / sponsor ID
- pre-FLAME / pre-FLAME
- Conditions
- Non Small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- 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
- 28 Dec 2021 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (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.
A prospective ,multicenter ,non-interventional ,real-world study observing changes in molecular markers after three weeks of osimertinib targeted therapy in EGFRm NSCLC
Detailed description
A prospective ,multicenter ,non-interventional ,real-world study observing changes in molecular markers after three weeks of osimertinib targeted therapy in Chinese patients with stage IIIB ,IIIC ,or IV metastatic or recurrent non squamous EGFR-positive non-small cell lung cancer
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 IIIB,IIIC,IV or recurrent NSCLC
Key inclusion criteria (6 listed)
- Male or female,age ≥18 years.
- Newly diagnosed,histologically confirmed,and classified as stage IIIB,IIIC,IV or recurrent NSCLC which are not amenable to curative surgery or radiotherapy .
- No prior systemic antitumor therapy, including EGFR -TKIs or immunotherapy .
- Presence of an EGFR mutation confirmed by a local laboratory in blood or tissue samples .
- Adequate blood samples available for molecular testing .
Key exclusion criteria (4 listed)
- Inability to provide plasma samples at baseline .
- Baseline blood EGFR mutation status not confirmed by the central laboratory .
- Refusal to receive subsequent treatment with osimertinib .
- Any condition that ,in the investigator's judgment ,could interfere with study procedures or confound outcome assessment .
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
describe the characteristics of EGFR mutations changes
Time frame: baseline and after three weeks of osimertinib treatment
To describe the characteristics of EGFR mutations changes at baseline and after three weeks of osimertinib treatment
1 secondary outcome
Characteristics of EGFR gene mutation and efficacy of oxitinib treatment
Time frame: baseline and after three weeks of osimertinib treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No
Related trials for Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Comparing TAK-928 With Docetaxel in Adults With Non-Small Cell Lung Cancer
IO Resistant Squamous and Nonsquamous NSCLC
RecruitingPhase 3
MK-3475A±Calderasib (MK-1084) in Completely Resected Stage IIA-IIIB (N2) KRAS G12Cm NSCLC (MK-1084-013)
Non-small Cell Lung Cancer
Not yet recruitingPhase 1
A Phase 1 Trial of KAN-001 With Pembrolizumab, With or Without Chemotherapy, in Participants With PD-L1-Positive Non-Small Cell Lung Cancer
Non-Small Cell Lung Cancer
RecruitingObservational study
Assessing Benefits and Harms of Cannabis/Cannabinoid Use Among Cancer Patients Treated in Community Oncology Clinics
Breast Carcinoma, Colorectal Carcinoma
RecruitingPhase 2
Testing Osimertinib as a Treatment for Lung Cancers With an EGFR Exon 20 Change
Advanced Lung Non-Small Cell Carcinoma, Recurrent Lung Non-Small Cell Carcinoma
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.
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 4 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: looking for participants now, as of the sponsor's last update on 2 Nov 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
describe the characteristics of EGFR mutations changes (time frame: baseline and after three weeks of osimertinib 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 2 Nov 2026.