Non-Small Cell Lung CancerPhase 2NCT05379803
High-dose Furmonertinib for First-line Treatment of EGFR Mutated NSCLC With Central Nervous System (CNS) Metastases
A Phase 2 study testing Furmonertinib in people with Non-Small Cell Lung Cancer, run by Hunan Province Tumor Hospital at 1 site in China.
Trial summary
EGFR mutated NSCLC patiens with CNS metastases have poor prognosis. High-dose furmonertinib (160mg/day) have produced high CNS PFS and ORR in second-line for EGFR T790M mutated NSCLC. Whether EGFR mutated NSCLC with CNS metastases can benefit from first-line treatment of high-dose furmonertinib has not been reported. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- 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
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2022to 31 Mar 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
- Signed written informed consent before any study-related procedure.
- Age ≥ 18 years.
- ECOG PS of 0 to 1 at screening,and with no clinically significant deterioration in the previous 2 weeks.
- Expected survival ≥12 weeks.
- Histologically or cytologically confirmed metastatic Non-Small Cell Lung Cancer (International Association for the Study of Lung Cancer and Joint Committee on the American Classification of Cancer, TNM Lung cancer stage 8). Documented validated results from local testing of either tumor tissue or blood confirming the presence of EGFR 19del or exon 21del L858R mutation. These mutations above may exist alone or together.
- According to RECIST 1.1, patients must have at least one central nervous system (CNS) metastatic tumor lesion at baseline that meets the following requirements: accurately and repeatably measurable at baseline, have no radiotherapy or biopsy.
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- Patients who have untreated for advanced/metastatic non-small cell lung cancer, including chemotherapy, biological therapy, targeted therapy, immunotherapy, or experimental therapy, prior to initiation of study drug therapy. Patients who have received adjuvant therapy or neoadjuvant therapy (chemotherapy and/or radiotherapy) are allowed to enroll if there is no progression within 6 months of treatment. Patients who have received topical therapy (radiotherapy or perfusion therapy) are allowed to enroll if the lesion within the local therapeutic area is non-targeted.
- For premenopausal women with childbearing potential, a pregnancy test must be performed within 14 days before the first dose, and the pregnancy test (blood or urine test) must be negative; female subjects must not be lactating;
- Willing to use contraception.
- Voluntary and agree to follow the study treatment protocol as well as follow-up plan, and can accept the oral medicine treatment.
Who cannot join
- Small cell lung carcinoma;
- History of hypersensitivity to active or inactive excipients of investigational agent with a similar chemical structure.
- Confirmed EGFR 20 exon insertion mutations at any time after the initial diagnosis.
- Patient who receive prior treatment including any of the following:
- Any Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI).
- The patients who have received intrapleural perfusion therapy can only be enrolled 28 days or more after the pleural effusion is stable;
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- Major surgery within 4 weeks of the first dose of investigational agent.
- Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of investigational agent;
- CYP3A4 strong inhibitor or strong inducer is used within 7 days prior to the first dose, or need to receive these drugs during the study period.
- Traditional Chinese medicine and traditional Chinese medicine preparations with anti-tumor as indications and with adjuvant treatment of tumor is used within 7 days prior to the first dose, or need to receive these drugs during the study period.
- Patients who are receiving drugs known to prolong QTc interval or may cause torsade de pointe and need to continue to receive these drugs during the study period.
- The time from the treatment with any other investigational product or its analogue to the first dose does not exceed 5 half-lives of the drug or 14 days, whichever is longer.
- Prior treatment with any systemic anti-cancer therapy for advanced Non-Small Cell Lung Cancer (NSCLC) including chemotherapy, biologic therapy, target therapy, immunotherapy, or any investigational drug, except neoadjuvant or adjuvant therapy before 6 months prior to the first dose investigational treatment.
- At the beginning of study treatment, any unresolved toxic reaction to prior treatment is present, which exceeds Grade 1 in accordance with Common Terminology Criteria for Adverse Events (CTCAE) (except for alopecia), and exceeds Grade 2 for prior platinum treatment-related neuropathy.
- Spinal cord compression; symptomatic and unstable brain metastases, except for those patients who have completed definitive therapy, are not on steroids, and have a stable neurological status for at least 2 weeks after completion of the definitive therapy and steroids.
- Diagnosed other malignant tumors or had a history of other malignant tumors in last 5 years, except for skin basal cell carcinoma, cervical carcinoma in situ and breast ductal carcinoma in situ which have been effectively controlled;
- Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of investigational agent.
- Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diatheses, and active infection, which in the Investigator's opinion makes it undesirable for the patient to participate in the trial.
- Past medical history of Interstitial Lung Disease (ILD), drug-induced Interstitial Lung Disease, radiation pneumonitis that required steroid treatment, or any evidence of clinically active Interstitial Lung Disease.
- Any evidence of corneal injury:
- Inadequate bone marrow reserve or organ function.
- QT prolongation or any clinically important abnormalities in rhythm and heart function.
- Patients who may have poor compliance with the research procedures and requirements, etc., as judged by investigators.
- Pregnancy or lactation.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hunan Cancer hospital
Changsha, Hunan
Yongchang Zhang, MD, +86 731 89762321, zhangyongchang@csu.edu.cn
About this study
Official title: A Single Arm, Multicenter Clinical Study of High-dose Furmonertinib in First-line Treatment of EGFR Mutated NSCLC With Central Nervous System (CNS) Metastases
EGFR mutated NSCLC patiens with CNS metastases have poor prognosis. High-dose furmonertinib (160mg/day) have produced high CNS PFS and ORR in second-line for EGFR T790M mutated NSCLC. Whether EGFR mutated NSCLC with CNS metastases can benefit from first-line treatment of high-dose furmonertinib has not been reported. This study aims to investigate the efficacy and safety of high dose furmonertinib in first-line treatment of EGFR mutated NSCLC patiens.
Read the detailed description
This is a single arm, multicenter clinical study and will recruit about 40 EGFR mutated NSCLC patients with CNS metastases in China. Furmonertinib is a third generation Epidermal Growth Factor Receptor (EGFR) tyrosine kinase inhibitor (TKI) .The recruited patients will receive high-dose furmonertinib (160mg/day) as first-line treatment. Whether EGFR mutated NSCLC with CNS metastases can benefit from first-line treatment of high-dose furmonertinib has not been reported. This study aims to investigate the efficacy and safety of high dose furmonertinib in first-line treatment of EGFR mutated NSCLC patiens.
- 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
Also called AST2818
furmonertinib 160 mg orally QD
| Study group | Role | What they receive |
|---|---|---|
| Furmonertinib | Experimental | furmonertinib 160 mg orally QD Receives: Drug: Furmonertinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Progression-free survival (PFS) is defined as the time from beginning of study treatment until the date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the patient withdraws from randomized therapy or receives another anti-cancer therapy prior to progression.
Measured: The primary analysis of Progression-free survival (PFS) based on investigator assessment will occur when PFS maturity is observed at approximately 26 months after the first patient begin study treatment
Secondary outcomes (3)
Central nervous system (CNS) progression-free survival
CNS PFS is defined as the time from beginning of study treatment until the date of objective progression of central nervous system or death (by any cause in the absence of CNS progression), regardless of whether the patient withdraws from study treatment or receives another anti-cancer therapy prior to progression.
Measured: Central nervous system (CNS) progression-free survival (PFS) analysis based on investigator assessment will occur at approximately 26 months after the first patient begin study treatment.
Objective Response Rate
defined as the number (%) of patients with response of Complete Response or Partial Response.
Measured: Objective Response Rate analysis will occur when Progression-free survival (PFS) maturity is observed at approximately 26 months from the first patient begin study treatment.
Disease Control Rate
defined as the number (%) of patients with CNS lesion response of Complete Response or Partial Response.
Measured: Disease Control Rate analysis will occur when Progression-free survival (PFS) maturity is observed at approximately 26 months from the first patient begin study treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start1 May 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hunan Province Tumor Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongchang Zhang, Hunan Province Tumor Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05379803
- Sponsor's protocol ID
- FORCE
- Status last verified
- Sep 2024
- First submitted
- 13 May 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yan H, Jiang W, Xiong Y, Liu L, Zhang R, Ruan Z, Huang Z, Dai J, Tian F, Zhou C, Wang Z, Yang H, Tao W, Zheng H, Xu Q, Yang N, Zeng L, Zhang Y. High-dose furmonertinib as first-line treatment for untreated EGFR-mutated advanced NSCLC with central nervous system metastases: A phase 2 trial. Cell Rep Med. 2026 Jul 21;7(7):102904. doi: 10.1016/j.xcrm.2026.102904. Epub 2026 Jun 30.
PubMed 42379171
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm, Multicenter Clinical Study of High-dose Furmonertinib in First-line Treatment of EGFR Mutated NSCLC With Central Nervous System (CNS) Metastases
- ClinicalTrials.gov ID
- NCT05379803
- Acronym / sponsor ID
- FORCE
- Conditions
- Non-Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hunan Province Tumor HospitalUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 18 May 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.
EGFR mutated NSCLC patiens with CNS metastases have poor prognosis. High-dose furmonertinib (160mg/day) have produced high CNS PFS and ORR in second-line for EGFR T790M mutated NSCLC. Whether EGFR mutated NSCLC with CNS metastases can benefit from first-line treatment of high-dose furmonertinib has not been reported. This study aims to investigate the efficacy and safety of high dose furmonertinib in first-line treatment of EGFR mutated NSCLC patiens.
Detailed description
This is a single arm, multicenter clinical study and will recruit about 40 EGFR mutated NSCLC patients with CNS metastases in China. Furmonertinib is a third generation Epidermal Growth Factor Receptor (EGFR) tyrosine kinase inhibitor (TKI) .The recruited patients will receive high-dose furmonertinib (160mg/day) as first-line treatment. Whether EGFR mutated NSCLC with CNS metastases can benefit from first-line treatment of high-dose furmonertinib has not been reported. This study aims to investigate the efficacy and safety of high dose furmonertinib in first-line treatment of EGFR mutated NSCLC patiens.
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: Furmonertinibfurmonertinib 160 mg orally QD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Signed written informed consent before any study-related procedure.
- Age ≥ 18 years.
- ECOG PS of 0 to 1 at screening,and with no clinically significant deterioration in the previous 2 weeks.
- Expected survival ≥12 weeks.
- Histologically or cytologically confirmed metastatic Non-Small Cell Lung Cancer (International Association for the Study of Lung Cancer and Joint Committee on the American Classification of Cancer, TNM Lung cancer stage 8). Documented validated results from local testing of either tumor tissue or blood confirming the presence of EGFR 19del or exon 21del L858R mutation. These mutations above may exist alone or together.
Key exclusion criteria (24 listed)
- Small cell lung carcinoma;
- History of hypersensitivity to active or inactive excipients of investigational agent with a similar chemical structure.
- Confirmed EGFR 20 exon insertion mutations at any time after the initial diagnosis.
- Patient who receive prior treatment including any of the following:
- Any Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI).
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 |
|---|---|---|
| FurmonertinibAlso: AST2818furmonertinib 160 mg orally QD | Drug | Furmonertinib |
Primary outcome
Progression-free survival
Time frame: The primary analysis of Progression-free survival (PFS) based on investigator assessment will occur when PFS maturity is observed at approximately 26 months after the first patient begin study treatment
Progression-free survival (PFS) is defined as the time from beginning of study treatment until the date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the patient withdraws from randomized therapy or receives another anti-cancer therapy prior to progression.
3 secondary outcomes
Central nervous system (CNS) progression-free survival
Time frame: Central nervous system (CNS) progression-free survival (PFS) analysis based on investigator assessment will occur at approximately 26 months after the first patient begin study treatment.
Objective Response Rate
Time frame: Objective Response Rate analysis will occur when Progression-free survival (PFS) maturity is observed at approximately 26 months from the first patient begin study treatment.
Disease Control Rate
Time frame: Disease Control Rate analysis will occur when Progression-free survival (PFS) maturity is observed at approximately 26 months from the first patient begin study treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Derived from this study: PubMed 42379171Yan H, Jiang W, Xiong Y, Liu L, Zhang R, Ruan Z, Huang Z, Dai J, Tian F, Zhou C, Wang Z, Yang H, Tao W, Zheng H, Xu Q, Yang N, Zeng L, Zhang Y. High-dose furmonertinib as first-line treatment for untreated EGFR-mutated advanced NSCLC with central nervous system metastases: A phase 2 trial. Cell Rep Med. 2026 Jul 21;7(7):102904. doi: 10.1016/j.xcrm.2026.102904. Epub 2026 Jun 30.
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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 Hunan Province Tumor 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 10 inclusion and 24 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 19 Sep 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.
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 Nong C Yang, MD (+8613873123436 ext. +8613873123436, yangnongpi@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: The primary analysis of Progression-free survival (PFS) based on investigator assessment will occur when PFS maturity is observed at approximately 26 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?
On the ClinicalTrials.gov record for NCT05379803, which also lists 1 linked publication.
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 Sep 2024.