Non-small Cell Lung CancerPhase 2NCT05445310
Adjuvant Furmonertinib in Stage IA With High Risk Factors and Stage IB Non-small Cell Lung Cancer
A Phase 2 study testing Furmonertinib in people with Non-small Cell Lung Cancer, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This is a prospective, single arm study to investigate the efficacy and safety furmonertinib 80mg/d as adjuvant treatment for 3 years post surgery of stage IA with high-risk factors and stage IB non-small cell lung cancer. A total of 114 patients would be enrolled. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Furmonertinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteChina
- Study dates
- 6 Aug 2022to 1 Jul 2026
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Received radical resection of non-small cell lung cancer without prior anti-tumor therapies including radiotherapy, chemotherapy, target therapy and immunotherapy.
- Histologically diagnosed Non-small cell lung cancer based on the judgement of at least 2 pathologists.
- Stage IA with high risk factors including micropapillae or solid components, vascular invasion, spread through air spaces, low differentiation, tumor budding and insufficient lymph node dissection; Stage IB with or without high-risk factors. The pathological stage is based on the 8th edition of AJCC lung cancer staging.
- EGFR mutation positive according to NGS testing by tissue, including deletions in exon 19, L858R, S768I, G719X, L861Q, T790M mutations et al.
- ECOG performance status 0-1.
- Sufficient organ function in liver, renal, kidney and hematology.
- With written signed informed consent form, ability to report adverse events, and good adherence to clinical study.
Who cannot join
- Lung cancer with small cell or neuroendocrine cancer cell.
- EGFR exon 20 insertion positive.
- Concurrent with other diver mutations including alterations in ALK, ROS1, MET et al.
- Women who are pregnant or breastfeeding.
- Use of CYP3A4 strong depressant within 7 days or CYP3A4 strong inducer within 21 days prior to initial administration, use of other anti-tumor treatment including traditional Chinese medicine within 14 days before enrollment.
- Concurrent with other malignancies excluding carcinoma in situ.
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- With uncontrolled systematic diseases such as active bleeding, unstable angina, heart infarction within 1 year, chronic heart failure and uncontrolled hypertension and diabetes mellitus; with active infection of HBV, HCV or HIV, or other infections requiring injection of antibiotics.
- Gastrointestinal disorders which may affect drug taking or absorption.
- With history of QT prolongation or relative risk factors including heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome et al.
- With history of interstitial lung disease or relative risk.
- Allergic to any component of furmonertinib tablet.
- Mental illness or drug abuse.
- Live vaccination within 30 days before enrollment.
- Other situation judged by investigator such as failure to follow the rules of study.
- Attending another study of investigational drug, or received other study drugs or medical devices with 4 weeks before enrollment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hopital
Beijing
Ruixuan Geng, MD, ginkrice@sina.com
About this study
Official title: Adjuvant Furmonertinib in Stage IA With High Risk Factors and Stage IB Non-small Cell Lung Cancer: a Prospective Single-arm Study
This is a prospective, single arm study to investigate the efficacy and safety furmonertinib 80mg/d as adjuvant treatment for 3 years post surgery of stage IA with high-risk factors and stage IB non-small cell lung cancer. A total of 114 patients would be enrolled. The primary endpoint is the disease-free survival rate at 3 years.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Furmonertinib
- 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.
FurmonertinibDrug
Furmonertinib 80mg/d
| Study group | Role | What they receive |
|---|---|---|
| Furmonertinib | Experimental | Patients will receive furmonertinib 80mg/d for 3 years or until disease recurrence or treatment cessation for other reasons. Receives: Drug: Furmonertinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival rate at 3 years
The rate of survival patients without disease recurrence at 3 years
Measured: 3 years following the first dose of study drug
Secondary outcomes (4)
Overall survival rate at 3 years
The rate of survival patients at 3 years
Measured: 3 years following the first dose of study drug
Median disease-free survival
The median time from the enrollment to the disease recurrence or death depending on the protocol
Measured: Approximately 3 years following the first dose of study drugs
Median overall survival
The median time from the enrollment to death of any cause depending on the protocol
Measured: Approximately 5 years following the first dose of study drugs
Adverse events
The number of patients with adverse events and the severity according to CTCAE v5.0
Measured: Approximately 3 years following the first dose of study drugs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study start6 Aug 2022
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2026 (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.
- More trials run by Peking Union Medical College 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05445310
- Sponsor's protocol ID
- AST-PMR2201
- Status last verified
- May 2022
- First submitted
- 15 Jun 2022
- Last updated
- 16 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Blinded IPD are to be shared on the requirements of supervision department and overall results of the study are to be published on academic conferences and journals.
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Furmonertinib in Stage IA With High Risk Factors and Stage IB Non-small Cell Lung Cancer: a Prospective Single-arm Study
- ClinicalTrials.gov ID
- NCT05445310
- Acronym / sponsor ID
- AST-PMR2201
- Conditions
- Non-small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 6 Aug 2022 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 6 Jul 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.
This is a prospective, single arm study to investigate the efficacy and safety furmonertinib 80mg/d as adjuvant treatment for 3 years post surgery of stage IA with high-risk factors and stage IB non-small cell lung cancer. A total of 114 patients would be enrolled. The primary endpoint is the disease-free survival rate at 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Furmonertinib | Experimental | Drug: FurmonertinibPatients will receive furmonertinib 80mg/d for 3 years or until disease recurrence or treatment cessation for other reasons. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Received radical resection of non-small cell lung cancer without prior anti-tumor therapies including radiotherapy, chemotherapy, target therapy and immunotherapy.
- Histologically diagnosed Non-small cell lung cancer based on the judgement of at least 2 pathologists.
- Stage IA with high risk factors including micropapillae or solid components, vascular invasion, spread through air spaces, low differentiation, tumor budding and insufficient lymph node dissection; Stage IB with or without high-risk factors. The pathological stage is based on the 8th edition of AJCC lung cancer staging.
- EGFR mutation positive according to NGS testing by tissue, including deletions in exon 19, L858R, S768I, G719X, L861Q, T790M mutations et al.
- ECOG performance status 0-1.
Key exclusion criteria (15 listed)
- Lung cancer with small cell or neuroendocrine cancer cell.
- EGFR exon 20 insertion positive.
- Concurrent with other diver mutations including alterations in ALK, ROS1, MET et al.
- Women who are pregnant or breastfeeding.
- Use of CYP3A4 strong depressant within 7 days or CYP3A4 strong inducer within 21 days prior to initial administration, use of other anti-tumor treatment including traditional Chinese medicine within 14 days before enrollment.
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 |
|---|---|---|
| FurmonertinibFurmonertinib 80mg/d | Drug | Furmonertinib |
Primary outcome
Disease-free survival rate at 3 years
Time frame: 3 years following the first dose of study drug
The rate of survival patients without disease recurrence at 3 years
4 secondary outcomes
Overall survival rate at 3 years
Time frame: 3 years following the first dose of study drug
Median disease-free survival
Time frame: Approximately 3 years following the first dose of study drugs
Median overall survival
Time frame: Approximately 5 years following the first dose of study drugs
Adverse events
Time frame: Approximately 3 years following the first dose of study drugs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
- Individual participant dataSharing planned: No. Blinded IPD are to be shared on the requirements of supervision department and overall results of the study are to be published on academic conferences and journals.
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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?
A Phase 2 study testing Furmonertinib in people with Non-small Cell Lung Cancer, run by Peking Union Medical College 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 7 inclusion and 15 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 16 Feb 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Ruixuan Geng, MD (86-10-69158753, ginkrice@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival rate at 3 years (time frame: 3 years following the first dose of study drug). 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 16 Feb 2023.