NSCLCPhase 1FAVOURNCT04858958
Study of FURMONERTINIB in Patients With NSCLC Having Exon 20 Insertion Mutation
A Phase 1 study testing Furmonertinib 160mg and Furmonertinib 240mg in people with NSCLC, run by Allist Pharmaceuticals, Inc. at 1 site in China.
Trial summary
This is a phase Ⅰb multi-center clinical study. To explore the preliminary efficacy and safety of Furmonertinib Mesilate at different doses in locally advanced or metastatic NSCLC patients with EGFR exon 20 insertion mutation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- NSCLC
- What is being tested?
- Furmonertinib 160mg and Furmonertinib 240mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 10 Aug 2020to 25 Jun 2025
- Phase
- Phase 1
- 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
- Man or woman aged ≥18 years;
- Histologically or cytopathologically confirmed primary non-small cell lung cancer (NSCLC) with predominant non-squamous cell histology;
- The treated patients must have radiological disease progression following the last anti-tumor therapy; and the treatment-naïve patients must have documented positive EGFR exon 20 insertion mutation by laboratory tests prior to enrollment;
- Subjects meeting either of the following conditions (in accordance with the AJCC 8th edition TNM stage classification for lung cancer):
- Treated patients: patients with locally advanced (judged by investigators as not suitable for surgery or radiotherapy) or metastatic NSCLC who are confirmed to have radiological or pathological disease progression during or after the last systematic anti-tumor therapy before the first dose of investigational product
- Treatment-naïve patients: patients with locally advanced (judged by investigators as not suitable for surgery or radiotherapy) or metastatic NSCLC who have no prior systematic anti-tumor therapy before the first dose of investigational product. If the time from the completion of adjuvant or neoadjuvant therapy to the first disease progression is > 6 months, the patients will be eligible for enrollment to the study; if it is ≤6 months, the patients will be regarded as treated patients and evaluated in accordance with the criteria for treated patients
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- Having at least one measurable lesion (in accordance with RECIST1.1). Note: measurable lesion can neither be subject to local therapy as radiotherapy nor used for biopsy in screening period; if there is only one measurable lesion, this lesion will be permitted to be biopsied. However, the baseline radiological examination can be performed for this lesion at least 14 days after biopsy.
- Adequate organ function as shown in the laboratory test, including:
- Life expectancy >12 weeks after the first dose of investigational product;
- Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose of investigational product; female subjects of non-childbearing potential may not undergo pregnancy test or contraception. Non-childbearing potential is defined as: 50 years and above, no use of hormone therapy and amenorrhea for at least 12 months; or having received sterilization operation. Female subjects at childbearing age and male subjects agree to take effective contraceptive measures during the study and within 6 months after drug discontinuation;
- Being able to understand and voluntarily participate in the study, and sign the informed consent form.
Who cannot join
- NSCLC with predominant squamous cell histology, small cell lung cancer or neuroendocrine carcinoma indicated by Histology or cytology test;
- Expected to receive other anti-tumor therapy other than the investigational product during the study;
- Treatment-naïve patients: having previously received systematic anti-tumor therapy targeting EGFR pathway (marketed drugs or drugs under development, EGFR TKI or antibody)
- Treated patients: having previously received systematic anti-tumor therapy with 3rd-generation EGFR TKI (marketed drugs or drugs under development) ;
- Having received the following therapies:
- Having been irradiated for >30% bone marrow or a large area within 4 weeks prior to the first dose of investigational product;
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- Having received major surgery within 4 weeks prior to the first dose of investigational product or plan to receive major surgery during the study with exception of the surgical procedures to establish vascular access, biopsy through mediastinoscopy or thoracoscopy;
- Use of a potent CYP3A4 inhibitor within 7 days prior to the first dose of investigational product or a potent CYP3A4 inducer within 21 days prior to the first dose of investigational product; use of the traditional Chinese medicine or traditional Chinese medicine preparation with tumor indication, or traditional Chinese medicine or traditional Chinese medicine preparation with adjuvant anti-tumor effect within two weeks prior to the first dose of investigational product or expected to be required during the study;
- Having participated in the clinical trial and received the investigational product or device within 4 weeks or at least 5 half-lives prior to the first dose of investigational product;
- Having received other anti-tumor drugs within 14 days prior to the first dose of investigational product;
- Concurrent spinal cord compression or symptomatic brain metastasis. Subjects with stable brain metastasis will be eligible. Stable brain metastasis is defined as the patients who have completed regular treatment for brain metastasis, are clinically stable or asymptomatic for at least two weeks and do not need steroid therapy. If the investigator considers there is no indication of immediate radical treatment, patients with asymptomatic brain metastasis will be eligible.
- The toxicity caused by previous anti-tumor therapy has not recovered to ≤CTCAE grade 1 (CTCAE 5.0) ( except alopecia, sequelae of previous platinum-related neurotoxicity) or the level specified in the inclusion/exclusion criteria;
- Unstable pleural effusion or peritoneal effusion with obvious symptoms; those with stable clinical symptoms for at least 28 days after drainage of pleural effusion or ascites will be eligible;
- Having a history of other malignant tumor, or other concurrent malignant tumors (except those that have undergone radical operation and have no recurrence within 5 years post operation, e.g., cervical carcinoma in situ, basal cell carcinoma of skin and papillary thyroid carcinoma);
- Previous interstitial lung disease (ILD), drug-induced interstitial lung disease, radiation pneumonitis requiring steroid therapy; or having the clinical manifestations of suspected interstitial lung disease;
- Having severe or uncontrolled systemic disease requiring treatment that is considered by investigators as ineligible for the study, including hypertension, diabetes, chronic heart failure (NYHA Functional Classification III-IV), unstable angina pectoris, myocardial infarction within one year, active hemorrhagic disease, etc.;
- Left ventricular ejection fraction (LVEF) <50% on echocardiography;
- Clinically significant prolonged QT interval or other arrhythmia or clinical status considered by investigators that may increase the risk of prolonged QT interval; for example, QTc>470 ms on ECG at resting state, complete left bundle branch block, degree III atrioventricular block, congenital long QT syndrome, serious hypokalemia, or current use of drugs that may lead to prolonged QT interval;
- Serious gastrointestinal dysfunction, or disease that may affect the intake, transportation or absorption of investigational product;
- Known hepatitis B virus (positive HBsAg), hepatitis C virus (positive HCV Ab) or human immunodeficiency virus (positive HIV antibody) infection;
- Infectious disease requiring intravenous medication;
- Known history of mental disease or drug abuse, and currently having an attack or still taking drugs;
- Known or suspected allergy to Furmonertinib or other components of its preparation;
- Female subjects or female partners of male subjects who are pregnant or lactating, or plan to be pregnant during the study;
- Poor compliance, inability to comply with the study procedures, restriction or requirements;
- Other conditions that are considered by investigators as unsuitable to participate in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase Ib, Randomized, Open-label, Multi-center Study to Evaluate the Preliminary Efficacy and Safety of Furmonertinib Mesilate in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutation
This is a phase Ⅰb multi-center clinical study. To explore the preliminary efficacy and safety of Furmonertinib Mesilate at different doses in locally advanced or metastatic NSCLC patients with EGFR exon 20 insertion mutation.
The study plans to enroll 30 subjects, including 20 treated patients and 10 treatment-naïve patients. The subjects with disease progression after previous systematic anti-tumor therapy will be randomized to receive Furmonertinib Mesilate 160 mg/day (N=10) or 240 mg/day (N=10), respectively. The treatment-naïve patients do not need to be randomized and all will receive Furmonertinib Mesilate 240 mg/day (N=10) until disease progression, death or intolerability.
Read more
The primary endpoint is ORR; the secondary study endpoints include DCR, DOR, DepOR, PFS, OS, CNS ORR, safety and the PK profile of Furmonertinib Mesilate and its metabolites (AST5902).
In addition, the peripheral blood ctDNA will be collected and analyzed in this study
- Conditions
- NSCLC
- Being tested
- Furmonertinib 160mg, Furmonertinib 240mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Furmonertinib 160mgDrug
randomized to 160mg QD
Furmonertinib 240mgDrug
randomized to 240mg QD
| Study group | Role | What they receive |
|---|---|---|
| treated subjects will receive Furmonertinib 160mg/day, | Experimental | treated subjects will receive Furmonertinib 160mg/day, QD, PO, under fasted state, until progressive disease, death or intolerability. Receives: Drug: Furmonertinib 160mg |
| treated subjects will receive Furmonertinib 240mg/day, | Experimental | treated subjects will receive Furmonertinib 160mg/day, QD, PO, under fasted state, until progressive disease, death or intolerability. Receives: Drug: Furmonertinib 240mg |
| treatment-naïve subjects will receive Furmonertinib 240mg/day | Experimental | Treatment naïve patients with EGFR exon 20 insertion mutation positive NSCLC Receives: Drug: Furmonertinib 240mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR, objective response rate
The proportion of subjects who achieve Complete Response (CR) and Partial Response (PR) by the best response from the first dose of Furmonertinib to the end of study.
Measured: up to 12 months
Secondary outcomes (3)
DCR,
The proportion of subjects who achieve CR, PR, and Stable Disease (SD) by the best response from the first dose of Furmonertinib to the end of study.
Measured: up to 12 months
DOR
The proportion of subjects who achieve CR, PR, and Stable Disease (SD) by the best response from the first dose of Furmonertinib to the end of study.
Measured: up to 12 months
PFS
PFS is defined as the time from randomization or start of study treatment until objective tumor progression or death depending on study protocol
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start10 Aug 2020
- Primary completion5 Dec 2024
- Study completion25 Jun 2025
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.
- More trials run by Allist Pharmaceuticals, Inc.The 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allist Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Baohui C Han, PHd, Principal investigator, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04858958
- Sponsor's protocol ID
- Protocol No.: ALSC012AST2818
- Acronym
- FAVOUR
- Status last verified
- Aug 2026
- First submitted
- 12 Apr 2021
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib, Randomized, Open-label, Multi-center Study to Evaluate the Preliminary Efficacy and Safety of Furmonertinib Mesilate in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutation
- ClinicalTrials.gov ID
- NCT04858958
- Acronym / sponsor ID
- FAVOUR / Protocol No.: ALSC012AST2818
- Conditions
- NSCLC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Allist Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Aug 2020 (actual)
- Primary completion
- 5 Dec 2024 (actual)
- Study completion
- 25 Jun 2025 (actual)
- First posted
- 26 Apr 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 phase Ⅰb multi-center clinical study. To explore the preliminary efficacy and safety of Furmonertinib Mesilate at different doses in locally advanced or metastatic NSCLC patients with EGFR exon 20 insertion mutation.
The study plans to enroll 30 subjects, including 20 treated patients and 10 treatment-naïve patients. The subjects with disease progression after previous systematic anti-tumor therapy will be randomized to receive Furmonertinib Mesilate 160 mg/day (N=10) or 240 mg/day (N=10), respectively. The treatment-naïve patients do not need to be randomized and all will receive Furmonertinib Mesilate 240 mg/day (N=10) until disease progression, death or intolerability.
The primary endpoint is ORR; the secondary study endpoints include DCR, DOR, DepOR, PFS, OS, CNS ORR, safety and the PK profile of Furmonertinib Mesilate and its metabolites (AST5902).
In addition, the peripheral blood ctDNA will be collected and analyzed in this study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| treated subjects will receive Furmonertinib 160mg/day, | Experimental | Drug: Furmonertinib 160mgtreated subjects will receive Furmonertinib 160mg/day, QD, PO, under fasted state, until progressive disease, death or intolerability. |
| treated subjects will receive Furmonertinib 240mg/day, | Experimental | Drug: Furmonertinib 240mgtreated subjects will receive Furmonertinib 160mg/day, QD, PO, under fasted state, until progressive disease, death or intolerability. |
| treatment-naïve subjects will receive Furmonertinib 240mg/day | Experimental | Drug: Furmonertinib 240mgTreatment naïve patients with EGFR exon 20 insertion mutation positive NSCLC |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Man or woman aged ≥18 years;
- Histologically or cytopathologically confirmed primary non-small cell lung cancer (NSCLC) with predominant non-squamous cell histology;
- The treated patients must have radiological disease progression following the last anti-tumor therapy; and the treatment-naïve patients must have documented positive EGFR exon 20 insertion mutation by laboratory tests prior to enrollment;
- Subjects meeting either of the following conditions (in accordance with the AJCC 8th edition TNM stage classification for lung cancer):
- Treated patients: patients with locally advanced (judged by investigators as not suitable for surgery or radiotherapy) or metastatic NSCLC who are confirmed to have radiological or pathological disease progression during or after the last systematic anti-tumor therapy before the first dose of investigational product
Key exclusion criteria (26 listed)
- NSCLC with predominant squamous cell histology, small cell lung cancer or neuroendocrine carcinoma indicated by Histology or cytology test;
- Expected to receive other anti-tumor therapy other than the investigational product during the study;
- Treatment-naïve patients: having previously received systematic anti-tumor therapy targeting EGFR pathway (marketed drugs or drugs under development, EGFR TKI or antibody)
- Treated patients: having previously received systematic anti-tumor therapy with 3rd-generation EGFR TKI (marketed drugs or drugs under development) ;
- Having received the following therapies:
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 160mgrandomized to 160mg QD | Drug | treated subjects will receive Furmonertinib 160mg/day, |
| Furmonertinib 240mgrandomized to 240mg QD | Drug | treated subjects will receive Furmonertinib 240mg/day,, treatment-naïve subjects will receive Furmonertinib 240mg/day |
Primary outcome
ORR, objective response rate
Time frame: up to 12 months
The proportion of subjects who achieve Complete Response (CR) and Partial Response (PR) by the best response from the first dose of Furmonertinib to the end of study.
3 secondary outcomes
DCR,
Time frame: up to 12 months
DOR
Time frame: up to 12 months
PFS
Time frame: up to 12 months
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 14 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
Baohui C Han, PHd principal investigator
Shanghai Chest Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Furmonertinib 160mg and Furmonertinib 240mg in people with NSCLC, run by Allist Pharmaceuticals, Inc. 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 11 inclusion and 26 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 14 Aug 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
ORR, objective response rate (time frame: up to 12 months). 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 14 Aug 2026.