FurmonertinibPhase 2NCT05465343
Furmonertinib in EGFR-Mutant NSCLC With Brain Metastases (iFORCE)
A Phase 2 study testing Furmonertinib 160 mg, Q.D. in people with Furmonertinib and EGFR-mutation, run by Peking Union Medical College at 1 site in China.
Trial summary
This study is a single-arm, open-label, prospective phase II trial. The aim of this phase II study is to evaluate the efficacy and safety of Furmonertinib in patients with EGFR mutation (including 19del or 21L858R or T790M) in advanced NSCLC with brain metastases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Furmonertinib, EGFR-mutation, NSCLC
- What is being tested?
- Furmonertinib 160 mg, Q.D.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 11 Jul 2022to 12 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.Male or Female aged ≥18 years old; 2.ECOG PS 0-2; 3.Histologically or cytopathologically confirmed non-small cell lung cancer (NSCLC) ; Tumor tissue samples or blood samples are confirmed to be EGFR mutations (including 19del or 21L858R or T790M); 4.Patients with brain metastases previously treated (chemotherapy, TKI), or intracranial progression after brain radiotherapy； 5.Life expectancy >3 months; 6.Without meningeal metastases; 7.According to mRECIST, the subject has at least 1 intracranial measurable lesion (≥ 5mm); 8.Adequate organ function (28 days before enrollment), including:
- Blood routine examination HB≥90 g/L（No blood transfusion within 14 days prior to enrollment） ANC≥1.5×109 /L PLT≥100×109 /L
- Biochemical examination TBIL≤1.5 times ULN AST and ALT≤2.5 times ULN (with liver metastasis, AST and ALT≤5 times ULN) Cr≤1×ULN，CrCL ≥50 mL /min (according to Cockcroft-Gault formula) PT/INR≤1.5 times ULN; aPTT≤1.5 times ULN (If the subject is receiving anticoagulation, PT or aPTT is within the therapeutic range expected for anticoagulant use) 9.No systemic corticosteroid therapy within 4 weeks prior to treatment; 10.Males of reproductive potential or females of potential pregnancy must take effective contraceptive measures (eg, oral contraceptives, intrauterine devices, abstinence or barrier contraception combined with spermicide) during the study and and within 12 months after drug discontinuation; 11.Being able to understand and voluntarily participate in the study, and sign the informed consent form, with good compliance and for follow-up.
Who cannot join
- 1.Known or suspected allergy to Furmonertinib or other components; 2.With EGFR Ex20ins mutation; 3.Subjects who have received other anti-tumor therapy within four weeks prior to the first dose of the study or who have failed to recover (≤ grade 1) from an adverse event resulting from prior treatment; 4.Any of the following cardiac criteria:
- QTc>470 ms on ECG at resting state, when the first abnormality occurs, the test is repeated 2 times within 48h, and the average result of 3 times is calculated.
- Various clinically significant abnormalities in rhythm, conduction, and resting ECG patterns, such as complete left bundle branch block, third-degree atrioventricular block, second-degree atrioventricular block, PR interval >250msec, etc.
- Factors that may increase the risk of QTc prolongation or the risk of arrhythmic events.
- 5.Pregnant or breastfeeding women; 6.Known hepatitis C virus (positive HCV Ab) or human immunodeficiency virus (positive HIV antibody) infection, positive HBsAg or HBCAb with positive HBV DNA copy number (>500 IU/ml); 7.Previous interstitial lung disease (ILD); 8.Having severe or uncontrolled systemic disease, including active opportunistic infection or progressive (severe) infection, uncontrolled diabetes, cardiovascular disease (III or IV heart failure by NYHA Functional Classification, second degree or greater atrioventricular block, myocardial infarction or unstable arrhythmia or unstable angina within the past 6 months, cerebral infarction within 3 months, etc.), pulmonary disease (interstitial pneumonia, obstructive pulmonary disease and history of symptomatic bronchospasm); 9.Meningeal metastases. Intracranial metastases with CNS symptoms may be enrolled if the metastases can be adequately treated and CNS symptoms can be restored to a level less than or equal to CTCAE1 and remain stable prior to enrollment; 10.Received a live vaccination within 4 weeks prior to the start of study treatment; 11.Major surgery (excluding diagnostic surgery) within 4 weeks prior to the start of treatment; 12.Known history of mental disease or drug abuse, and currently having an attack or still taking drugs; 13.Serious gastrointestinal dysfunction, or disease that may affect the intake, transportation or absorption of investigational product; 14.History of other malignant tumors within 3 years, except for cured basal cell carcinoma and cervical carcinoma in situ; 15.According to the investigators, subjects with other serious acute or chronic disease, mental disease , laboratory abnormalities that may increase the risk or interfere with the interpretation of study results are excluded; 16.Subjects who are or have been involved in other clinical studies within 4 weeks; 17.According to the investigator, subjects may not complete this study or may not comply with the requirements of this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Furmonertinib in Patients With EGFR Mutations in Advanced NSCLC With Brain Metastases: A Prospective, Open-label, Phase II Trial（iFORCE）
This study is a single-arm, open-label, prospective phase II trial. The aim of this phase II study is to evaluate the efficacy and safety of Furmonertinib in patients with EGFR mutation (including 19del or 21L858R or T790M) in advanced NSCLC with brain metastases.
- Conditions
- Furmonertinib, EGFR-mutation, NSCLC, Brain Metastases
- Being tested
- Furmonertinib 160 mg, Q.D.
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Furmonertinib 160 mg, Q.D.Drug
Furmonertinib 160 mg orally once daily in previously treated groups
| Study group | Role | What they receive |
|---|---|---|
| previously treated | Experimental | advanced NSCLC previously treated with systemic therapy, including chemotherapy and targeted therapy Receives: Drug: Furmonertinib 160 mg, Q.D. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intracranial Progression Free Survival (iPFS)
The time from the first does of the study drugs to the intracranial progression of the disease or death for any reason.
Measured: Approximately 18 months after the first patient begin study treatment
Secondary outcomes (7)
Intracranial Objective Response Rate (iORR)
Proportion of subjects whose intracranial tumors were assessed as complete response(CR) or partial response(PR) according to mRECIST.
Measured: Approximately 12 weeks after the first patient begin study treatment
Intracranial Disease Control Rate (iDCR)
Proportion of subjects whose intracranial tumors were assessed as complete response(CR), partial response(PR), or stable disease(SD) according to mRECIST.
Measured: Approximately 18 months from the first patient begin study treatment
Objective Response Rate (ORR)
Proportion of subjects whose tumors were assessed as complete response(CR) or partial response(PR) according to RECIST 1.1.
Measured: Approximately 12 weeks following the first dose of study drug
Disease Control Rate (DCR)
Proportion of subjects whose tumors were assessed as CR, PR or stable disease (SD) according to RECIST 1.1.
Measured: Approximately 18 months from the first patient begin study treatment
Disease progression free survival (PFS)
The time from the first does of the study drugs to the progression of the disease or death for any reason.
Measured: Approximately 18 months after the first patient begin study treatment
Overall survival (OS)
The time from the first does of the study drugs to the death for any reason.
Measured: Approximately 24 months after the first patient begin study treatment
Adverse Events (AEs)
The number of patients with adverse events and the severity according to CTCAE v5.0
Measured: From the start of study drug to 28 days after the last dose of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2022
- Study start11 Jul 2022
- Primary completion12 Dec 2025
- Study completion12 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FurmonertinibStudies 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junling Li, Peking Union Medical College
- Investigators
- Junling Li, Professor, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05465343
- Sponsor's protocol ID
- NCC3050
- Status last verified
- Dec 2025
- First submitted
- 15 Jul 2022
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- 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 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Furmonertinib in Patients With EGFR Mutations in Advanced NSCLC With Brain Metastases: A Prospective, Open-label, Phase II Trial（iFORCE）
- ClinicalTrials.gov ID
- NCT05465343
- Acronym / sponsor ID
- NCC3050
- Conditions
- Furmonertinib, EGFR-mutation, NSCLC, Brain Metastases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Peking Union Medical CollegeUniversity, hospital or other
- Study start
- 11 Jul 2022 (actual)
- Primary completion
- 12 Dec 2025 (actual)
- Study completion
- 12 Dec 2025 (actual)
- First posted
- 19 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 study is a single-arm, open-label, prospective phase II trial. The aim of this phase II study is to evaluate the efficacy and safety of Furmonertinib in patients with EGFR mutation (including 19del or 21L858R or T790M) in advanced NSCLC with brain metastases.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| previously treated | Experimental | Drug: Furmonertinib 160 mg, Q.D.advanced NSCLC previously treated with systemic therapy, including chemotherapy and targeted therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1.Male or Female aged ≥18 years old; 2.ECOG PS 0-2; 3.Histologically or cytopathologically confirmed non-small cell lung cancer (NSCLC) ; Tumor tissue samples or blood samples are confirmed to be EGFR mutations (including 19del or 21L858R or T790M); 4.Patients with brain metastases previously treated (chemotherapy, TKI), or intracranial progression after brain radiotherapy； 5.Life expectancy >3 months; 6.Without meningeal metastases; 7.According to mRECIST, the subject has at least 1 intracranial measurable lesion (≥ 5mm); 8.Adequate organ function (28 days before enrollment), including:
- Blood routine examination HB≥90 g/L（No blood transfusion within 14 days prior to enrollment） ANC≥1.5×109 /L PLT≥100×109 /L
- Biochemical examination TBIL≤1.5 times ULN AST and ALT≤2.5 times ULN (with liver metastasis, AST and ALT≤5 times ULN) Cr≤1×ULN，CrCL ≥50 mL /min (according to Cockcroft-Gault formula) PT/INR≤1.5 times ULN; aPTT≤1.5 times ULN (If the subject is receiving anticoagulation, PT or aPTT is within the therapeutic range expected for anticoagulant use) 9.No systemic corticosteroid therapy within 4 weeks prior to treatment; 10.Males of reproductive potential or females of potential pregnancy must take effective contraceptive measures (eg, oral contraceptives, intrauterine devices, abstinence or barrier contraception combined with spermicide) during the study and and within 12 months after drug discontinuation; 11.Being able to understand and voluntarily participate in the study, and sign the informed consent form, with good compliance and for follow-up.
Key exclusion criteria (5 listed)
- 1.Known or suspected allergy to Furmonertinib or other components; 2.With EGFR Ex20ins mutation; 3.Subjects who have received other anti-tumor therapy within four weeks prior to the first dose of the study or who have failed to recover (≤ grade 1) from an adverse event resulting from prior treatment; 4.Any of the following cardiac criteria:
- QTc>470 ms on ECG at resting state, when the first abnormality occurs, the test is repeated 2 times within 48h, and the average result of 3 times is calculated.
- Various clinically significant abnormalities in rhythm, conduction, and resting ECG patterns, such as complete left bundle branch block, third-degree atrioventricular block, second-degree atrioventricular block, PR interval >250msec, etc.
- Factors that may increase the risk of QTc prolongation or the risk of arrhythmic events.
- 5.Pregnant or breastfeeding women; 6.Known hepatitis C virus (positive HCV Ab) or human immunodeficiency virus (positive HIV antibody) infection, positive HBsAg or HBCAb with positive HBV DNA copy number (>500 IU/ml); 7.Previous interstitial lung disease (ILD); 8.Having severe or uncontrolled systemic disease, including active opportunistic infection or progressive (severe) infection, uncontrolled diabetes, cardiovascular disease (III or IV heart failure by NYHA Functional Classification, second degree or greater atrioventricular block, myocardial infarction or unstable arrhythmia or unstable angina within the past 6 months, cerebral infarction within 3 months, etc.), pulmonary disease (interstitial pneumonia, obstructive pulmonary disease and history of symptomatic bronchospasm); 9.Meningeal metastases. Intracranial metastases with CNS symptoms may be enrolled if the metastases can be adequately treated and CNS symptoms can be restored to a level less than or equal to CTCAE1 and remain stable prior to enrollment; 10.Received a live vaccination within 4 weeks prior to the start of study treatment; 11.Major surgery (excluding diagnostic surgery) within 4 weeks prior to the start of treatment; 12.Known history of mental disease or drug abuse, and currently having an attack or still taking drugs; 13.Serious gastrointestinal dysfunction, or disease that may affect the intake, transportation or absorption of investigational product; 14.History of other malignant tumors within 3 years, except for cured basal cell carcinoma and cervical carcinoma in situ; 15.According to the investigators, subjects with other serious acute or chronic disease, mental disease , laboratory abnormalities that may increase the risk or interfere with the interpretation of study results are excluded; 16.Subjects who are or have been involved in other clinical studies within 4 weeks; 17.According to the investigator, subjects may not complete this study or may not comply with the requirements of this study.
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 |
|---|---|---|
| Furmonertinib 160 mg, Q.D.Furmonertinib 160 mg orally once daily in previously treated groups | Drug | previously treated |
Primary outcome
Intracranial Progression Free Survival (iPFS)
Time frame: Approximately 18 months after the first patient begin study treatment
The time from the first does of the study drugs to the intracranial progression of the disease or death for any reason.
7 secondary outcomes
Intracranial Objective Response Rate (iORR)
Time frame: Approximately 12 weeks after the first patient begin study treatment
Intracranial Disease Control Rate (iDCR)
Time frame: Approximately 18 months from the first patient begin study treatment
Objective Response Rate (ORR)
Time frame: Approximately 12 weeks following the first dose of study drug
Disease Control Rate (DCR)
Time frame: Approximately 18 months from the first patient begin study treatment
Disease progression free survival (PFS)
Time frame: Approximately 18 months after the first patient begin study treatment
Overall survival (OS)
Time frame: Approximately 24 months after the first patient begin study treatment
Adverse Events (AEs)
Time frame: From the start of study drug to 28 days after the last dose of study drug
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- 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.
Junling Li, Professor principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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 160 mg, Q.D. in people with Furmonertinib and EGFR-mutation, run by Peking Union Medical College 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 3 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: finished, as of the sponsor's last update on 19 Dec 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intracranial Progression Free Survival (iPFS) (time frame: Approximately 18 months after the first patient begin study 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 19 Dec 2025.