NSCLCPhase 2NCT05466149
Efficacy and Safety of Furmonertinib in Patients With Locally Advanced or Metastatic NSCLC With EGFR Exon 20 Insertion
A Phase 2 study testing Furmonertinib in people with NSCLC, run by Allist Pharmaceuticals, Inc. at 1 site in China.
Trial summary
This is a Phase 2, Multicenter, Open-Label Study to Assess the Efficacy and Safety of Furmonertinib in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Mutations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC
- What is being tested?
- Furmonertinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 27 Sep 2022to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Age ≥ 18 years at time of signing Informed Consent Form
- Histologically or cytologically documented, locally advanced or metastatic NSCLC not amenable to curative surgery or radiotherapy
- Documented validated results from local or central testing (as designated by the Sponsor) of blood or tumor tissue confirming the presence of an EGFR exon 20 insertion mutation
- Documented radiologic progression on or after prior platinum-based chemotherapy (with or without anti-PD1/PD-L1 agents) in the locally advanced or metastatic setting
- Documented radiologic disease progression during or after the last systemic anticancer therapy before the first dose of furmonertinib
- Measurable disease per RECIST v1.1
Show all 11Show fewer
- ECOG performance status of 0 or 1
- Life expectancy of ≥ 12 weeks
- Patients with CNS metastases are eligible, provided they meet all of the following criteria: Measurable disease outside the CNS; No ongoing requirement for corticosteroids as therapy for CNS metastases, with corticosteroids discontinued for ≥ 2 weeks prior to enrollment; No ongoing symptoms attributed to CNS metastases; No active CNS metastases or spinal cord compression (i.e., progressing or requiring anticonvulsants or corticosteroids for symptomatic control); No evidence of interim CNS disease progression between the completion of CNS-directed therapy and the screening radiographic study; Time since whole brain radiation therapy (WBRT) is ≥ 21 days prior to first dose of study treatment, time since stereotactic radiosurgery (SRS) is ≥ 7 days prior to first dose of study treatment, or time since surgical resection is ≥ 28 days
- Adequate hematologic and organ function within 14 days prior to initiation of study treatment
- For women of childbearing potential or men who are not surgically sterile: Agreement to remain abstinent or use contraception, and agreement to refrain from donating eggs or sperm
Who cannot join
- Prior treatment with any EGFR-targeting agents (e.g., EGFR tyrosine kinase inhibitors [TKIs], monoclonal antibodies, or bispecific antibodies).
- More than 3 prior systemic anticancer therapy regimens for locally advanced or metastatic NSCLC
- Inability or unwillingness to swallow pills
- Severe acute or chronic infections
- Previous interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis requiring steroid therapy; or having the clinical manifestations of suspected ILD
- History of or active clinically significant cardiovascular dysfunction
Show all 9Show fewer
- Mean resting corrected QT interval (QTc) > 470 msec, obtained from triplicate ECGs, using the screening clinic ECG machine derived Fridericia's formula (QTcF) value
- Clinically significant prolonged QT interval or other arrhythmia or clinical status considered by investigators that may increase the risk of prolonged QT interval (e.g., complete left bundle branch block, degree III atrioventricular block, second-degree heart block, PR interval > 250 msec, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first-degree relatives, serious hypokalemia, heart failure) or current use of the drugs that may lead to prolonged QT interval.
- AEs from prior anticancer therapy that have not resolved to Grade ≤ 1 except for alopecia, vitiligo, endocrinopathy managed with replacement therapy, or Grade ≤ 2 peripheral neuropathy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2, Multicenter, Open-Label Study to Assess the Efficacy and Safety of Furmonertinib in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Mutations
This is a Phase 2, Multicenter, Open-Label Study to Assess the Efficacy and Safety of Furmonertinib in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Mutations.
The study plans to enroll approximately 100 patients from approximately 70 sites. Patients are locally advanced or metastatic NSCLC with EGFR exon 20 insertions who have progressed during or after platinum-based chemotherapy. Furmonertinib Mesilate will be treated 240 mg QD until disease progression or unacceptable toxicity.
Primary endpoint is ORR. Secondary endpoints include DOR, DCR, DepOR, PFS, OS, CNS ORR, CNS DOR, CNS PFS, safety and the PK profile of Furmonertinib Mesilate and its metabolites (AST5902).
- Conditions
- NSCLC
- Being tested
- Furmonertinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FurmonertinibDrug
Also called AST2818
240mg QD on a continuous dosing schedule.
| Study group | Role | What they receive |
|---|---|---|
| Furmonertinib 240mg QD | Experimental | Treating patients of locally advanced or metastatic NSCLC with EGFR exon 20 insertions who have progressed during or after platinum-based chemotherapy. Receives: Drug: Furmonertinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR, Objective Response Rate
Percentage of patients with a confirmed CR or PR relative to the total number of patients.
Measured: Approximately 7.5 months following the last patient enrolled
Secondary outcomes (9)
DOR, Duration of response
Time from first documented evidence of confirmed CR or PR until the first documented evidence of disease progression or death, whichever occurs earlier
Measured: Approximately 7.5 months following the last patient enrolled
DCR, Disease control rate
Proportion of patients with CR, PR, or SD
Measured: Approximately 7.5 months following the last patient enrolled
Depth of response
Maximum reduction in BICR and investigator assessment using RECIST v1.1 compared to baseline
Measured: Approximately 7.5 months following the last patient enrolled
PFS, Progression Free Survival
Time from first dose date to the first occurrence of disease progression, or death from any cause, whichever occurs first
Measured: Approximately 7.5 months following the last patient enrolled
OS, Overall Survival
Time from first dose to death from any cause
Measured: Approximately 3 years following the last patient enrolled
CNS ORR, CNS DOR, CNS PFS
Evaluated by BICR per modified RECIST criteria in patients with CNS lesion(s) on baseline brain scan
Measured: Approximately 7.5 months following the last patient enrolled
Adverse Events
Incidence and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0).
Measured: Until 28 days from the last dose of study drugs or initiation of a new anticancer treatment
Maximum Plasma Concentration [Cmax]
Plasma concentrations of furmonertinib and its major metabolite (AST5902) at specified time points
Measured: Approximately 7.5 months following the last patient enrolled
Minimum Plasma Concentration [Cmin]
Plasma concentrations of furmonertinib and its major metabolite (AST5902) at specified time points
Measured: Approximately 7.5 months following the last patient enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start27 Sep 2022
- Primary completion27 Jun 2025
- Study completionDec 2026 (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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Allist Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05466149
- Sponsor's protocol ID
- FURMO-003
- Status last verified
- Aug 2026
- First submitted
- 14 Jul 2022
- Last updated
- 14 Aug 2026
- Results posted
- 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 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Open-Label Study to Assess the Efficacy and Safety of Furmonertinib in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Mutations
- ClinicalTrials.gov ID
- NCT05466149
- Acronym / sponsor ID
- FURMO-003
- Conditions
- NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Allist Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Sep 2022 (actual)
- Primary completion
- 27 Jun 2025 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 20 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 is a Phase 2, Multicenter, Open-Label Study to Assess the Efficacy and Safety of Furmonertinib in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Mutations.
The study plans to enroll approximately 100 patients from approximately 70 sites. Patients are locally advanced or metastatic NSCLC with EGFR exon 20 insertions who have progressed during or after platinum-based chemotherapy. Furmonertinib Mesilate will be treated 240 mg QD until disease progression or unacceptable toxicity.
Primary endpoint is ORR. Secondary endpoints include DOR, DCR, DepOR, PFS, OS, CNS ORR, CNS DOR, CNS PFS, safety and the PK profile of Furmonertinib Mesilate and its metabolites (AST5902).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Furmonertinib 240mg QD | Experimental | Drug: FurmonertinibTreating patients of locally advanced or metastatic NSCLC with EGFR exon 20 insertions who have progressed during or after platinum-based chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥ 18 years at time of signing Informed Consent Form
- Histologically or cytologically documented, locally advanced or metastatic NSCLC not amenable to curative surgery or radiotherapy
- Documented validated results from local or central testing (as designated by the Sponsor) of blood or tumor tissue confirming the presence of an EGFR exon 20 insertion mutation
- Documented radiologic progression on or after prior platinum-based chemotherapy (with or without anti-PD1/PD-L1 agents) in the locally advanced or metastatic setting
- Documented radiologic disease progression during or after the last systemic anticancer therapy before the first dose of furmonertinib
Key exclusion criteria (9 listed)
- Prior treatment with any EGFR-targeting agents (e.g., EGFR tyrosine kinase inhibitors [TKIs], monoclonal antibodies, or bispecific antibodies).
- More than 3 prior systemic anticancer therapy regimens for locally advanced or metastatic NSCLC
- Inability or unwillingness to swallow pills
- Severe acute or chronic infections
- Previous interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis requiring steroid therapy; or having the clinical manifestations of suspected ILD
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: AST2818240mg QD on a continuous dosing schedule. | Drug | Furmonertinib 240mg QD |
Primary outcome
ORR, Objective Response Rate
Time frame: Approximately 7.5 months following the last patient enrolled
Percentage of patients with a confirmed CR or PR relative to the total number of patients.
9 secondary outcomes
DOR, Duration of response
Time frame: Approximately 7.5 months following the last patient enrolled
DCR, Disease control rate
Time frame: Approximately 7.5 months following the last patient enrolled
Depth of response
Time frame: Approximately 7.5 months following the last patient enrolled
PFS, Progression Free Survival
Time frame: Approximately 7.5 months following the last patient enrolled
OS, Overall Survival
Time frame: Approximately 3 years following the last patient enrolled
CNS ORR, CNS DOR, CNS PFS
Time frame: Approximately 7.5 months following the last patient enrolled
Adverse Events
Time frame: Until 28 days from the last dose of study drugs or initiation of a new anticancer treatment
Maximum Plasma Concentration [Cmax]
Time frame: Approximately 7.5 months following the last patient enrolled
Minimum Plasma Concentration [Cmin]
Time frame: Approximately 7.5 months following the last patient enrolled
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- 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 2 study testing Furmonertinib 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 9 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: under way, not looking for participants, 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 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?
This study is still under way. Results are not available in the source record yet.
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: Approximately 7.5 months following the last patient enrolled). 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.