NSCLCPhase 2ATHEMNCT05165355
Adjuvant Targeted-therapy for Patients With Resected High-risk EGFR-mutant Stage IB-IIA Non-small Cell Lung Carcinoma
A Phase 2 study testing Furmonertinib in people with NSCLC and EGF-R Positive Non-Small Cell Lung Cancer, run by Tongji University at 1 site in China.
Trial summary
This is a single-armed study designed to evaluate the safety and efficacy of adjuvant targeted-therapy in patients with epidermal growth factor receptor mutation positive stage IB-IIA non-small cell lung carcinoma and high-risk of recurrence following complete tumor resection. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- NSCLC, EGF-R Positive Non-Small Cell Lung Cancer
- What is being tested?
- Furmonertinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 28 Dec 2021to Feb 2025
- 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
- Subjects aged ≥18 and ≤75 years old；
- ECOG performance status score 0-1；
- Stage ⅠB-ⅡA（according to the 8th Edition of the AJCC Staging system）；
- Complete surgical resection of the primary NSCLC is mandatory；
- Histologically confirmed diagnosis of high-risk pathological subtype (micropapillary, solid pattern or spread through air spaces [STAS], etc.);
- The tumour harbours one of the most common EGFR mutations (19del or L858R) ;
- Normal organ and bone marrow function measured before the study as defined below:
- 1) Hemoglobin (HGB)≥90g/L 2) White blood cell count (WBC) is 4.0~10×10^9/L 3) Absolute value of neutrophil (ANC)≥1.5×10^9/L 4) Platelet (PLT) count≥100×109/L 5) Serum total bilirubin (TBIL)≤1.5×ULN 6) AST and/or ALT≤2.5×ULN 7) International normalized ratio（INR）≤1.5 and activated partial thromboplastin time (APTT) is normal 8) Serum creatinine (SCr)≤1.5 × ULN 8. No previous systemic anti-tumor therapy for malignant tumor, such as chemotherapy, radiotherapy or hormonotherapy. No history of other malignancies, subjects with prostate cancer who received hormone therapy and had more than 5 years of DFS were excluded; 9. Subjects have voluntarily participated, signed and dated informed consent.
Who cannot join
- Double primary lung cancer or multiple primary lung cancer;
- Subjects with mental illness;
- Presence or concomitant hemorrhagic diseases;
- Pregnancy or lactation;
- Known or suspected to be allergic to Furmonertinib and / or other components of their preparations.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200080
Jiang Fan, MD, 02163240090, fan_jiang@tongji.edu.cn
Jiang Fan, MD
About this study
Official title: A Phase II, Single-armed Study to Assess the Efficacy and Safety of Furmonertinib in Patients With Epidermal Growth Factor Receptor Mutation Positive Stage IB-IIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection.
This is a single-armed study designed to evaluate the safety and efficacy of adjuvant targeted-therapy in patients with epidermal growth factor receptor mutation positive stage IB-IIA non-small cell lung carcinoma and high-risk of recurrence following complete tumor resection.
The primary endpoint: 2-year DFS rate; The second endpoint: DFS
- Conditions
- NSCLC, EGF-R Positive Non-Small Cell Lung Cancer
- Being tested
- Furmonertinib
- Keywords
- NSCLC, EGFR mutation, adjuvant therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FurmonertinibDrug
Furmonertinib (80 mg orally, once daily) for 3 years.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Furmonertinib (80 mg orally, once daily) for 3 years. Receives: Drug: Furmonertinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Free Survival (DFS) rate at 2 years
Assess the Efficacy of Adjuvant Furmonertinib as Measured by 2-year Disease Free Survival (DFS) rate.
Measured: From date of receiving therapy until date of disease recurrence or death (by any cause in the absence of recurrence), up to approximately 4 years. Assessed at 2 years.
Secondary outcomes (1)
Disease Free Survival (DFS)
Assess the Efficacy of Adjuvant Furmonertinib as Measured by Disease Free Survival (DFS).
Measured: From date of receiving therapy until date of disease recurrence or death (by any cause in the absence of recurrence), up to approximately 4 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2021
- Study start28 Dec 2021
- Primary completionNov 2024 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiang Fan, Tongji University
- Investigators
- Jiang Fan, MD, Principal investigator, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05165355
- Sponsor's protocol ID
- SGHDOT 21-12
- Acronym
- ATHEM
- Status last verified
- Jan 2022
- First submitted
- 20 Dec 2021
- Last updated
- 18 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 18 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Single-armed Study to Assess the Efficacy and Safety of Furmonertinib in Patients With Epidermal Growth Factor Receptor Mutation Positive Stage IB-IIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection.
- ClinicalTrials.gov ID
- NCT05165355
- Acronym / sponsor ID
- ATHEM / SGHDOT 21-12
- Conditions
- NSCLC, EGF-R Positive Non-Small Cell Lung Cancer
- Keywords
- NSCLC, EGFR mutation, adjuvant therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Tongji UniversityUniversity, hospital or other
- Study start
- 28 Dec 2021 (actual)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 21 Dec 2021 (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 single-armed study designed to evaluate the safety and efficacy of adjuvant targeted-therapy in patients with epidermal growth factor receptor mutation positive stage IB-IIA non-small cell lung carcinoma and high-risk of recurrence following complete tumor resection.
The primary endpoint: 2-year DFS rate; The second endpoint: DFS
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: FurmonertinibFurmonertinib (80 mg orally, once daily) for 3 years. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects aged ≥18 and ≤75 years old；
- ECOG performance status score 0-1；
- Stage ⅠB-ⅡA（according to the 8th Edition of the AJCC Staging system）；
- Complete surgical resection of the primary NSCLC is mandatory；
- Histologically confirmed diagnosis of high-risk pathological subtype (micropapillary, solid pattern or spread through air spaces [STAS], etc.);
Key exclusion criteria (5 listed)
- Double primary lung cancer or multiple primary lung cancer;
- Subjects with mental illness;
- Presence or concomitant hemorrhagic diseases;
- Pregnancy or lactation;
- Known or suspected to be allergic to Furmonertinib and / or other components of their preparations.
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 (80 mg orally, once daily) for 3 years. | Drug | Experimental group |
Primary outcome
Disease Free Survival (DFS) rate at 2 years
Time frame: From date of receiving therapy until date of disease recurrence or death (by any cause in the absence of recurrence), up to approximately 4 years. Assessed at 2 years.
Assess the Efficacy of Adjuvant Furmonertinib as Measured by 2-year Disease Free Survival (DFS) rate.
1 secondary outcome
Disease Free Survival (DFS)
Time frame: From date of receiving therapy until date of disease recurrence or death (by any cause in the absence of recurrence), up to approximately 4 years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2022.
- 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.
Jiang Fan, MD principal investigator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
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 NSCLC and EGF-R Positive Non-Small Cell Lung Cancer, run by Tongji University 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 8 inclusion and 5 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 18 Jan 2022. 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 Jiang Fan, MD (15901013210, fan_jiang@tongji.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Free Survival (DFS) rate at 2 years (time frame: From date of receiving therapy until date of disease recurrence or death (by any cause in the absence of recurrence), up to approximately 4 years. Assessed at 2 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 18 Jan 2022.