NSCLCPhase 1NCT04958967

Phase Ib Study of FURMONERTINIB in Patients with NSCLC Having Exon 20 Insertion Mutation

A Phase 1 study testing Furmonertinib 240mg and Furmonertinib 160mg in people with NSCLC, run by Allist Pharmaceuticals, Inc. at 1 site in China.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

This is a phase 1 multi-center clinical study. To explore the 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 240mg and Furmonertinib 160mg
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: 1 siteChina
Study dates: 1 Oct 2021to 1 Aug 2022
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;
Treated patients: progress or intolerance after receiving at least one and no more than three lines of systemic treatment (including at least one chemotherapy or immunotherapy) for locally advanced or metastatic NSCLC disease; If the completion time of adjuvant or neoadjuvant treatment is less than or equal to 6 months from the time of the first disease progression, it is evaluated in accordance with the criteria for treated patients Treatment-naïve patients t without any systemic anti-tumor therapy for locally advanced or metastatic NSCLC; If the completion time of adjuvant or neoadjuvant treatment is more than 6 months from the time of first disease progression, the patients be eligible for enrollment to the study;
The Participants should provide enough ctDNA in peripheral blood during the screening period, and at the same time, they should provide enough advanced tumor tissue sections as far as possible for central laboratory testing to confirm the mutation type of EGFR 20 exon (please refer to the manual of central laboratory for details);
Participants meeting either of the following conditions (in accordance with the AJCC 8th edition TNM stage classification for lung cancer):
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.

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Adequate organ function as shown in the laboratory test, including: 1)Absolute neutrophil count (ANC) ≥ 1.5 × 109/L; platelet count (PLT) ≥ 100 × 109/L; hemoglobin (HGB) ≥ 90 g/L; 2)Serum total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN), AST and ALT ≤ 2.5 × ULN (total bilirubin ≤ 3 × ULN, AST and ALT ≤ 5 × ULN in patients with hepatic metastasis); 3)Creatinine clearance (CrCL) ≥ 50 ml/min (using Cockcroft- Gault formula); Prothrombin time (PT) ≤ 1.5 × ULN;
ECOG PS score 0-1 at screening, no obvious exacerbation of disease within 2 weeks prior to screening;
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

Any potential participant who meets any of the following criteria will be excluded fromparticipating in the study:
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;
Treated patients: having previously received systematic anti-tumor therapy with 3rd-generation EGFR TKI (marketed drugs or drugs under development) ;
1）Therapeutic drugs (such as dzd9008, tak788, jnj-372, bocitinib, etc.) for EGFR 20 exon insertion mutation; 2)The third generation of EGFR TKI (marketed or in research drug); 3） The first and second generation EGFR TKI (marketed drugs or drugs in Research) targeting the insertion mutation of EGFR 20 exon had objective remission;
Having received the following therapies:

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Having been irradiated for >30% bone marrow or a large area within 4 weeks prior to the first dose of investigational product;
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 14 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;

Trial locations and contacts

1 site in 1 country.

China1 site

Shanghai Chest hospital
Shanghai

Other trials in China

About this study

Official title: A Phase Ib Open-Label, Randomization Multi-Center Study to Evaluate Efficacy and Safety of FURMONERTINIB MESILATE in PATIENTS with LOCALLY ADVANCED or METASTATIC NON-SMALL CELL LUNG CANCER HARBOURING EGFR EXON 20 INSERTION MUTATION

The study plans to enroll 20subjects, including 20 treated patients aThe subjects will receive Furmonertinib Mesilate 240 mg/day or 160mg/day until disease progression, death or intolerability.

The primary endpoint is Overall Response Rate (ORR) as Assessed by the Independent Review Committee (IRC); the secondary study endpoints include ORR（ Assessed by the Investigator），DCR，DOR，DpR，PFS，OS，CNS ORR（ Assessed by the Independent Review Committee） In addition, the peripheral blood ctDNA will be collected and analyzed in this study

Conditions: NSCLC
Being tested: Furmonertinib 240mg, Furmonertinib 160mg

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Furmonertinib 240mgDrug
treated subjects will receive Furmonertinib 240mg/day
Furmonertinib 160mgDrug
treated subjects will receive Furmonertinib 160mg/day

Study groups in NCT04958967
Study group	Role	What they receive
treated subjects will receive Furmonertinib 240mg/day,	Experimental	treated subjects will receive Furmonertinib 240mg/day, QD, PO, under fasted state, until progressive disease, death or intolerability. Receives: Drug: Furmonertinib 240mg
treated subjects will receive Furmonertinib 160mg/day	Experimental	treated subjects will receive Furmonertinib 160 mg/day, QD, PO, under fasted state, until progressive disease, death or intolerability. Receives: Drug: Furmonertinib 160mg

What is being measured

The primary outcome is the main question the study is designed to answer.

ORR, objective response rate
IRC assessed objective response rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 in participants with epidermal growth factor receptor EGFRmutations. These outcome is based on the visual assessment of tumor size in morphological images provided by computed tomography (CT) or magnetic resonance imaging.ORR is defined as the percentage of participants achieving complete response (CR) and partial response (PR) per RECIST version 1.1. CR: Disappearance of all extranodal target lesions; PR: At least a 30% decrease in Sum of the Longest Diameters (SLD) of target lesions, taking as a reference the baseline SLD.
Measured: up to 12 months

Secondary outcomes (3)

Duration of Response (DOR)
Duration of response is defined as the time interval from the time that the measurement criteria are first met for CR/PR (whichever is first recorded) until the first date that PD is objectively documented.
Measured: up to 2 years
Disease Control Rate (DCR)
DCR is defined as the percentage of participants who have achieved CR, PR, or stable disease (SD) (in the case of SD, measurements must have met the SD criteria at least once after study entry at a minimum interval of 42 days) after the initiation of study drug.
Measured: up to 2 years
Progression Free Survival (PFS)
PFS is defined as the time interval from the date of randomization until the first date at which the criteria for progressive disease (PD) according to RECIST version 1.1 are met or death, whichever occurs first.
Measured: up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 20211 Aug 2022

First posted12 Jul 2021
Study start1 Oct 2021 (estimated)
Primary completion1 May 2022 (estimated)
Study completion1 Aug 2022 (estimated)

Why it stopped: The protocol need to review

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: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04958967
Sponsor's protocol ID: ALSC015AST2818
Status last verified: Jul 2021
First submitted: 5 Jul 2021
Last updated: 14 Mar 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
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A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
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RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer

All NSCLC trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase Ib Open-Label, Randomization Multi-Center Study to Evaluate Efficacy and Safety of FURMONERTINIB MESILATE in PATIENTS with LOCALLY ADVANCED or METASTATIC NON-SMALL CELL LUNG CANCER HARBOURING EGFR EXON 20 INSERTION MUTATION
ClinicalTrials.gov ID: NCT04958967
Acronym / sponsor ID: ALSC015AST2818
Conditions: NSCLC
Phase: Phase 1
Study type: Interventional
Recruitment status: WithdrawnReason stopped: The protocol need to review
Enrolment: 0 participants (actual)
Lead sponsor: Allist Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Study start: 1 Oct 2021 (estimated)
Primary completion: 1 May 2022 (estimated)
Study completion: 1 Aug 2022 (estimated)
First posted: 12 Jul 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.

The study plans to enroll 20subjects, including 20 treated patients aThe subjects will receive Furmonertinib Mesilate 240 mg/day or 160mg/day until disease progression, death or intolerability.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
treated subjects will receive Furmonertinib 240mg/day,	Experimental	Drug: Furmonertinib 240mgtreated subjects will receive Furmonertinib 240mg/day, QD, PO, under fasted state, until progressive disease, death or intolerability.
treated subjects will receive Furmonertinib 160mg/day	Experimental	Drug: Furmonertinib 160mgtreated subjects will receive Furmonertinib 160 mg/day, QD, PO, under fasted state, until progressive disease, death or intolerability.

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;
Treated patients: progress or intolerance after receiving at least one and no more than three lines of systemic treatment (including at least one chemotherapy or immunotherapy) for locally advanced or metastatic NSCLC disease; If the completion time of adjuvant or neoadjuvant treatment is less than or equal to 6 months from the time of the first disease progression, it is evaluated in accordance with the criteria for treated patients Treatment-naïve patients t without any systemic anti-tumor therapy for locally advanced or metastatic NSCLC; If the completion time of adjuvant or neoadjuvant treatment is more than 6 months from the time of first disease progression, the patients be eligible for enrollment to the study;
The Participants should provide enough ctDNA in peripheral blood during the screening period, and at the same time, they should provide enough advanced tumor tissue sections as far as possible for central laboratory testing to confirm the mutation type of EGFR 20 exon (please refer to the manual of central laboratory for details);
Participants meeting either of the following conditions (in accordance with the AJCC 8th edition TNM stage classification for lung cancer):

Key exclusion criteria (27 listed)

Any potential participant who meets any of the following criteria will be excluded fromparticipating in the study:
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;
Treated patients: having previously received systematic anti-tumor therapy with 3rd-generation EGFR TKI (marketed drugs or drugs under development) ;
1）Therapeutic drugs (such as dzd9008, tak788, jnj-372, bocitinib, etc.) for EGFR 20 exon insertion mutation; 2)The third generation of EGFR TKI (marketed or in research drug); 3） The first and second generation EGFR TKI (marketed drugs or drugs in Research) targeting the insertion mutation of EGFR 20 exon had objective remission;

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 240mgtreated subjects will receive Furmonertinib 240mg/day	Drug	treated subjects will receive Furmonertinib 240mg/day,
Furmonertinib 160mgtreated subjects will receive Furmonertinib 160mg/day	Drug	treated subjects will receive Furmonertinib 160mg/day

Primary outcome

ORR, objective response rate
Time frame: up to 12 months
IRC assessed objective response rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 in participants with epidermal growth factor receptor EGFRmutations. These outcome is based on the visual assessment of tumor size in morphological images provided by computed tomography (CT) or magnetic resonance imaging.ORR is defined as the percentage of participants achieving complete response (CR) and partial response (PR) per RECIST version 1.1. CR: Disappearance of all extranodal target lesions; PR: At least a 30% decrease in Sum of the Longest Diameters (SLD) of target lesions, taking as a reference the baseline SLD.

3 secondary outcomes

Duration of Response (DOR)
Time frame: up to 2 years
Disease Control Rate (DCR)
Time frame: up to 2 years
Progression Free Survival (PFS)
Time frame: up to 2 years

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
Individual participant dataSharing planned: No

Related trials for NSCLC

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer

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.

The record lists no contact. Use the official record to reach the sponsor.

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 240mg and Furmonertinib 160mg 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 27 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: withdrawn, as of the sponsor's last update on 14 Mar 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 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 was withdrawn before enrolling participants, so there are no results.

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?

On the ClinicalTrials.gov record for NCT04958967.

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 Mar 2025.