Non-Small Cell Lung Cancer (NSCLC)Phase 1NCT05364073
Study of Furmonertinib in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Activating, Including Uncommon, Epidermal Growth Factor Receptor (EGFR) or Human Epidermal Growth Factor Receptor 2 (HER2) Mutations
A Phase 1 study testing Furmonertinib in people with Non-Small Cell Lung Cancer (NSCLC) and Metastatic Non-Small Cell Lung Cancer, run by ArriVent BioPharma, Inc. at 42 sites in 11 countries.
Trial summary
This is a Phase 1b, open-label, multi-center, dose-escalation and dose expansion study designed to evaluate the safety, pharmacokinetics (PK), and preliminary antitumor activity of furmonertinib in patients with advanced or metastatic non-small cell lung cancer (NSCLC) with activating, including uncommon, Epidermal… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer (NSCLC), Metastatic Non-Small Cell Lung Cancer, Advanced 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
- 160 participants
- Where
- 42 sitesin 11 countries
- Study dates
- 30 Jun 2022to 31 Dec 2026
- Phase
- Phase 1
- 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
- Histologically or cytologically documented, locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) not amenable to curative surgery or radiotherapy.
- Disease that has progressed after at least one available standard therapy; or for whom standard therapy has proven to be ineffective or intolerable; or for whom a clinical trial of an investigational agent is a recognized standard of care.
- Documented radiologic disease progression during or after the last systemic anti-cancer therapy before the first dose of furmonertinib.
- For patients with Epidermal Growth Factor Receptor (EGFR) mutations sensitive to osimertinib, the patient must have received osimertinib prior to study enrollment in regions where osimertinib is approved, including the US.
- Stage 1 dose escalation and backfill cohorts and Stage 2 Cohorts 1, 2, 3 and 4:
- -Patients with CNS metastases (including leptomeningeal disease) may be eligible if meeting additional protocol specified criteria.
Show all 22Show fewer
- Stage 1 Dose Escalation and Backfill Cohorts Inclusion Criteria:
- Documented validated results from local testing of tumor tissue or blood confirming the presence of an activating, including uncommon, EGFR mutation or HER2 exon 20 insertion mutation performed at a CLIA-or equivalently certified laboratory.
- Stage 2 Cohort 1 Previously Treated, Locally Advanced or Metastatic NSCLC Patients with EGFR Exon 20 Insertion Mutations Inclusion Criteria
- Documented validated results from local testing of either tumor tissue or blood confirming the presence of EGFR Exon 20 insertion mutations, performed at a CLIA- or equivalently certified laboratory.
- The patient must have experienced disease progression or have intolerance to treatment with platinum-based chemotherapy.
- Stage 2 Cohort 2 Previously treated, Locally Advanced or Metastatic NSCLC Patients with HER2 Exon 20 Insertion Mutations Inclusion Criteria
- Documented validated results from local testing of either tumor tissue or blood confirming the presence of HER2 Exon 20 insertion mutations, performed at a CLIA- or equivalently certified laboratory.
- The patient must have experienced disease progression or have intolerance to treatment with platinum-based chemotherapy.
- In regions in which fam-trastuzumab deruxtecan-nxki is approved and available for adult patients with unresectable or metastatic NSCLC whose tumors have activating HER2 exon 20 mutations, the patient must have received or be considered not appropriate to receive fam-trastuzumab deruxtecan-nxki.
- Stage 2 Cohort 3 Previously Treated, Locally Advanced or Metastatic NSCLC Patients with EGFR Activating Mutations Mutations, who are not eligible for Cohorts 1 and 4 Inclusion Criteria
- Documented validated results from local testing of either tumor tissue or blood confirming the presence of an EGFR activating mutation, performed at a CLIA- or equivalently certified laboratory.
- The patient must have experienced disease progression or have intolerance to treatment with the standard of care EGFR TKI.
- Patients with CNS metastases may be eligible if meeting additional protocol specified criteria.
- Stage 2 Cohort 4 Untreated or Previously Treated EGFR TKI-Naïve, Locally Advanced or Metastatic NSCLC Patients with EGFR Uncommon Mutations excluding EGFR Exon 20 insertions Inclusion Criteria
- Previously untreated in the locally advanced or metastatic setting or have progressed after at least 1 available standard therapy, or for whom standard therapy has proven to be ineffective, intolerable, or considered inappropriate
- Documented validated results from local testing of either tumor tissue or blood confirming the presence of an EGFR Uncommon mutation, performed at a CLIA- or equivalently certified laboratory a. Representative mutations include, but are not limited to, G719X, S768I, E709X, G779F, L747X, V774M, E709_T710delinsD, R776C/H, G724S, E736K, I740_K745dup, N771G, K757M/R, V769L/M, T854X, T751_I759delinsN
Who cannot join
- Treatment with chemotherapy, targeted therapy, biologic therapy or an investigational agent as anti-cancer therapy within 3 or 3 elimination weeks or five half-lives prior to initiation of furmonertinib, whichever is shorter, or endocrine therapy within 2 weeks prior to initiation of furmonertinib.
- Radiation therapy as cancer therapy within 4 weeks prior to initiation of furmonertinib.
- Palliative radiation to bone metastases within 2 weeks prior to initiation of furmonertinib.
- AE from prior anticancer therapy that have not resolved to Grade ≤ 1 except for alopecia or Grade ≤ 2 peripheral neuropathy.
- Stage 2 Cohort 4 Untreated or Previously Treated EGFR TKI-Naïve, Locally Advanced or Metastatic NSCLC Patients with EGFR Uncommon Mutations Exclusion Criteria
- Prior treatment with any EGFR TKIs
- Progression during neoadjuvant or adjuvant therapy (e.g., chemotherapy, radiotherapy, immunotherapy or investigational agents) or within 12 months of completion of above therapies.
Trial locations and contacts
42 sites in 11 countries.
42 sites in 11 countries
China14 sites
Allist Investigative Site
Beijing, Beijing Municipality, 101119
Allist Investigative Site
Changchun, Jilin, 130012
Allist Investigative Site
Chaoyang, Beijing Municipality, 100021
Allist Investigative Site
Chongqing, Chongqing Municipality, 400030
Allist Investigative Site
Harbin, Heilongjiang, 150081
Allist Investigative Site
Hefei, Anhui, 230001
Allist Investigative Site
Jinan, Shandong, 250021
Allist Investigative Site
Jinan, Shandong, 250117
Allist Investigative Site
Nanchang, Jianxi, 330008
Allist Investigative Site
Taiyuan, Shanxi, 030013
Allist Investigative Site
Wuhan, Hubei, 430022
Allist Investigative Site
Xuzhou, Jiangsu, 221000
Allist Investigative Site
Zhengzhou, Henan, 450003
Allist Investigative Site
Zhengzhou, Henan, 450052
United States7 sites
ArriVent Investigative Site
Celebration, Florida, 34747
ArriVent Investigative Site
Detroit, Michigan, 48202
ArriVent Investigative Site
Fairfax, Virginia, 22031
ArriVent Investigative Site
Houston, Texas, 77030
ArriVent Investigative Site
Prescott, Arizona, 86301
ArriVent Investigative Site
Sacramento, California, 95817
ArriVent Investigative Site
Whittier, California, 90603
Japan4 sites
ArriVent Investigative Site
Chiba, Chiba, 260-0013
Arrivent Investigative Site
Chūō, Tokyo, 104-0045
Arrivent Investigative Site
Koto-Ku, Tokyo, 135-8550
Arrivent Investigative Site
Ōsaka-sayama, Osaka, 589-8511
Spain4 sites
ArriVent Investigative Site
Barcelona, 08035
ArriVent Investigative Site
Madrid, 28033
ArriVent Investigative Site
Madrid, 28050
ArriVent Investigative Site
Valencia, 46026
Australia3 sites
ArriVent Investigative Site
Blacktown, New South Wales, 2148
ArriVent Investigative Site
Heidelberg, Victoria, 3084
ArriVent Investigative Site
St Leonards, New South Wales, 2065
France3 sites
ArriVent Investigative Site
Lyon, 69373
Arrivent Investigative Site
Toulouse, 31059
Arrivent Investigative Site
Villejuif, 94800
Canada2 sites
Arrivent Investigative Site
Edmonton, T6G 1Z2
Arrivent Investigative Site
Toronto, M5G 2M9
South Korea2 sites
Arrivent Investigative Site
Gwangju, 61469
Arrivent Investigative Site
Seoul, 2447
Netherlands1 site
Arrivent Investigative Site
Amsterdam, North Holland, 1066 CX
About this study
Official title: A Phase 1b Dose Escalation and Dose Expansion Study Evaluating the Safety, Pharmacokinetics, and Antitumor Activity of Furmonertinib in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Activating Epidermal Growth Factor Receptor (EGFR) or Human Epidermal Growth Factor Receptor 2 (HER2) Mutations
This is a Phase 1b, open-label, multi-center, dose-escalation and dose expansion study designed to evaluate the safety, pharmacokinetics (PK), and preliminary antitumor activity of furmonertinib in patients with advanced or metastatic non-small cell lung cancer (NSCLC) with activating, including uncommon, Epidermal Growth Factor Receptor (EGFR) or Human Epidermal Growth Factor Receptor 2 (HER2) mutations. Patients will be enrolled into one of 2 stages: Stage 1 (Dose Escalation and Backfill Cohorts) and Stage 2 (Dose Expansion).
- Conditions
- Non-Small Cell Lung Cancer (NSCLC), Metastatic Non-Small Cell Lung Cancer, Advanced Non-Small Cell Lung Cancer, HER2 Exon 20 Mutations, EGFR Exon 20 Mutations, EGFR Uncommon Mutations, Including G719X and S768I
- Being tested
- Furmonertinib
- Keywords
- Non-small cell lung cancer (NSCLC), Metastatic Non-Small Cell Lung Cancer, Advanced Non-Small Cell Lung Cancer, EGFR, HER2, Exon 20 Insertion Mutations, HER2 kinase domain mutations, Epidermal Growth Factor Receptor (EGFR) kinase domain mutations, Exon 20, Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Mutations, HER2 Exon 20 Insertion Mutations, Tyrosine Kinase Inhibitor (TKI), Human Epidermal Growth Factor Receptor 2 (HER2), Epidermal Growth Factor Receptor (EGFR), EGFR uncommon mutations, EGFR atypical mutations, EGFR rare mutations, V774M, G719X, S768I
- 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 tablet
FurmonertinibDrug
Also called AST2818
Furmonertinib tablet
FurmonertinibDrug
Also called AST2818
Furmonertinib tablet
FurmonertinibDrug
Also called AST2818
Furmonertinib tablet
FurmonertinibDrug
Also called AST2818
Furmonertinib tablet
| Study group | Role | What they receive |
|---|---|---|
| Stage 1 Dose Escalation and Backfill | Experimental | Experimental: Previously treated patients with advanced or metastatic NSCLC with activating EGFR or HER2 mutations Receives: Drug: Furmonertinib |
| Stage 2 Expansion Cohort 1 | Experimental | Previously Treated NSCLC Patients with EGFR Exon 20 Insertion Mutations Receives: Drug: Furmonertinib |
| Stage 2 Expansion Cohort 2 | Experimental | Previously treated NSCLC Patients with HER2 Exon 20 Insertion Mutations Receives: Drug: Furmonertinib |
| Stage 2 Expansion Cohort 3 | Experimental | Previously treated NSCLC Patients with EGFR Activating Mutations, who are not eligible for Cohorts 1 and 4 Receives: Drug: Furmonertinib |
| Stage 2 Expansion Cohort 4 | Experimental | Untreated or Previously treated EGFR TKI Naïve NSCLC Patients with EGFR Uncommon Mutations, excluding EGFR exon 20 insertion mutations Receives: Drug: Furmonertinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stage 1: Number of incidence and severity of adverse events (AEs) as a measure of safety and tolerability of Furmonertinib
Measured: Up to 36 months after first dose
Stage 2: Overall Response Rate (ORR)
Measured: Up to 36 months after first dose
Secondary outcomes (21)
Stage 1: Overall Response Rate
Measured: Up to 36 months after first dose
Stage 1: Duration of Response (DOR)
Measured: Up to 36 months after first dose
Stage 1: Disease Control Rate
Measured: Up to 36 months after first dose
Stage 1: Progression Free Survival
Measured: Up to 36 months after first dose
Stage 1: Depth of Response
Measured: Up to 36 months after first dose
Stage 1: Overall survival
Measured: Up to 36 months after first dose
Stage 1: Central Nervous System ORR
Measured: Up to 36 months after first dose
Stage 1: Central Nervous System DOR
Measured: Up to 36 months after first dose
Stage 1: Plasma concentrations of furmonertinib and its major metabolite (AST5902)
Measured: Up to 36 months after first dose
Stage 1, Cohort 1, Backfill only: Plasma concentrations of furmonertinib and its major metabolite (AST5902)
Measured: Up to 36 months after first dose
Stage 1, Cohort 1, Backfill only: Plasma concentrations of midazolam and its metabolite (1-OH-midazolam)
Measured: Up to 36 months after first dose
Stage 2, all cohorts: Duration of Response
Measured: Up to 36 months after first dose
Stage 2, all cohorts: Disease Control Rate
Measured: Up to 36 months after first dose
Stage 2, all cohorts: Progression Free Survival
Measured: Up to 36 months after first dose
Stage 2, all cohorts: Depth of Response
Measured: Up to 36 months after first dose
Stage 2, all cohorts: Overall survival
Measured: Up to 36 months after first dose
Stage 2, all cohorts: Central Nervous System ORR
Measured: Up to 36 months after first dose
Stage 2, all cohorts: Central Nervous System DOR
Measured: Up to 36 months after first dose
Stage 2, Cohort 4 only: Overall Response Rate
Measured: Up to 36 months after first dose
Stage 2, all cohorts: Number of incidence and severity of AEs as a measure of safety and tolerability of Furmonertinib
Measured: Up to 36 months after first dose
Stage 2, all cohorts: Plasma concentrations of furmonertinib and its major metabolite (AST5902)
Measured: Up to 36 months after first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2022
- Study start30 Jun 2022
- Primary completion3 Jun 2025
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung Cancer (NSCLC)Studies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- ArriVent BioPharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jamuna Thimmarayappa, Study director, ArriVent BioPharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05364073
- Sponsor's protocol ID
- FURMO-002
- Status last verified
- Mar 2026
- First submitted
- 6 Apr 2022
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Dose Escalation and Dose Expansion Study Evaluating the Safety, Pharmacokinetics, and Antitumor Activity of Furmonertinib in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Activating Epidermal Growth Factor Receptor (EGFR) or Human Epidermal Growth Factor Receptor 2 (HER2) Mutations
- ClinicalTrials.gov ID
- NCT05364073
- Acronym / sponsor ID
- FURMO-002
- Conditions
- Non-Small Cell Lung Cancer (NSCLC), Metastatic Non-Small Cell Lung Cancer, Advanced Non-Small Cell Lung Cancer, HER2 Exon 20 Mutations, EGFR Exon 20 Mutations, EGFR Uncommon Mutations, Including G719X and S768I
- Keywords
- Non-small cell lung cancer (NSCLC), Metastatic Non-Small Cell Lung Cancer, Advanced Non-Small Cell Lung Cancer, EGFR, HER2, Exon 20 Insertion Mutations, HER2 kinase domain mutations, Epidermal Growth Factor Receptor (EGFR) kinase domain mutations
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 160 participants (actual)
- Lead sponsor
- ArriVent BioPharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Jun 2022 (actual)
- Primary completion
- 3 Jun 2025 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 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.
This is a Phase 1b, open-label, multi-center, dose-escalation and dose expansion study designed to evaluate the safety, pharmacokinetics (PK), and preliminary antitumor activity of furmonertinib in patients with advanced or metastatic non-small cell lung cancer (NSCLC) with activating, including uncommon, Epidermal Growth Factor Receptor (EGFR) or Human Epidermal Growth Factor Receptor 2 (HER2) mutations. Patients will be enrolled into one of 2 stages: Stage 1 (Dose Escalation and Backfill Cohorts) and Stage 2 (Dose Expansion).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Stage 1 Dose Escalation and Backfill | Experimental | Drug: FurmonertinibExperimental: Previously treated patients with advanced or metastatic NSCLC with activating EGFR or HER2 mutations |
| Stage 2 Expansion Cohort 1 | Experimental | Drug: FurmonertinibPreviously Treated NSCLC Patients with EGFR Exon 20 Insertion Mutations |
| Stage 2 Expansion Cohort 2 | Experimental | Drug: FurmonertinibPreviously treated NSCLC Patients with HER2 Exon 20 Insertion Mutations |
| Stage 2 Expansion Cohort 3 | Experimental | Drug: FurmonertinibPreviously treated NSCLC Patients with EGFR Activating Mutations, who are not eligible for Cohorts 1 and 4 |
| Stage 2 Expansion Cohort 4 | Experimental | Drug: FurmonertinibUntreated or Previously treated EGFR TKI Naïve NSCLC Patients with EGFR Uncommon Mutations, excluding EGFR exon 20 insertion mutations |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Histologically or cytologically documented, locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) not amenable to curative surgery or radiotherapy.
- Disease that has progressed after at least one available standard therapy; or for whom standard therapy has proven to be ineffective or intolerable; or for whom a clinical trial of an investigational agent is a recognized standard of care.
- Documented radiologic disease progression during or after the last systemic anti-cancer therapy before the first dose of furmonertinib.
- For patients with Epidermal Growth Factor Receptor (EGFR) mutations sensitive to osimertinib, the patient must have received osimertinib prior to study enrollment in regions where osimertinib is approved, including the US.
- -Patients with CNS metastases (including leptomeningeal disease) may be eligible if meeting additional protocol specified criteria.
Key exclusion criteria (7 listed)
- Treatment with chemotherapy, targeted therapy, biologic therapy or an investigational agent as anti-cancer therapy within 3 or 3 elimination weeks or five half-lives prior to initiation of furmonertinib, whichever is shorter, or endocrine therapy within 2 weeks prior to initiation of furmonertinib.
- Radiation therapy as cancer therapy within 4 weeks prior to initiation of furmonertinib.
- Palliative radiation to bone metastases within 2 weeks prior to initiation of furmonertinib.
- AE from prior anticancer therapy that have not resolved to Grade ≤ 1 except for alopecia or Grade ≤ 2 peripheral neuropathy.
- Stage 2 Cohort 4 Untreated or Previously Treated EGFR TKI-Naïve, Locally Advanced or Metastatic NSCLC Patients with EGFR Uncommon Mutations Exclusion Criteria
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 tablet | Drug | Stage 1 Dose Escalation and Backfill |
| FurmonertinibAlso: AST2818Furmonertinib tablet | Drug | Stage 2 Expansion Cohort 1 |
| FurmonertinibAlso: AST2818Furmonertinib tablet | Drug | Stage 2 Expansion Cohort 2 |
| FurmonertinibAlso: AST2818Furmonertinib tablet | Drug | Stage 2 Expansion Cohort 3 |
| FurmonertinibAlso: AST2818Furmonertinib tablet | Drug | Stage 2 Expansion Cohort 4 |
Primary outcome
Stage 1: Number of incidence and severity of adverse events (AEs) as a measure of safety and tolerability of Furmonertinib
Time frame: Up to 36 months after first dose
Stage 2: Overall Response Rate (ORR)
Time frame: Up to 36 months after first dose
21 secondary outcomes
Stage 1: Overall Response Rate
Time frame: Up to 36 months after first dose
Stage 1: Duration of Response (DOR)
Time frame: Up to 36 months after first dose
Stage 1: Disease Control Rate
Time frame: Up to 36 months after first dose
Stage 1: Progression Free Survival
Time frame: Up to 36 months after first dose
Stage 1: Depth of Response
Time frame: Up to 36 months after first dose
Stage 1: Overall survival
Time frame: Up to 36 months after first dose
Stage 1: Central Nervous System ORR
Time frame: Up to 36 months after first dose
Stage 1: Central Nervous System DOR
Time frame: Up to 36 months after first dose
Stage 1: Plasma concentrations of furmonertinib and its major metabolite (AST5902)
Time frame: Up to 36 months after first dose
Stage 1, Cohort 1, Backfill only: Plasma concentrations of furmonertinib and its major metabolite (AST5902)
Time frame: Up to 36 months after first dose
Stage 1, Cohort 1, Backfill only: Plasma concentrations of midazolam and its metabolite (1-OH-midazolam)
Time frame: Up to 36 months after first dose
Stage 2, all cohorts: Duration of Response
Time frame: Up to 36 months after first dose
Stage 2, all cohorts: Disease Control Rate
Time frame: Up to 36 months after first dose
Stage 2, all cohorts: Progression Free Survival
Time frame: Up to 36 months after first dose
Stage 2, all cohorts: Depth of Response
Time frame: Up to 36 months after first dose
Stage 2, all cohorts: Overall survival
Time frame: Up to 36 months after first dose
Stage 2, all cohorts: Central Nervous System ORR
Time frame: Up to 36 months after first dose
Stage 2, all cohorts: Central Nervous System DOR
Time frame: Up to 36 months after first dose
Stage 2, Cohort 4 only: Overall Response Rate
Time frame: Up to 36 months after first dose
Stage 2, all cohorts: Number of incidence and severity of AEs as a measure of safety and tolerability of Furmonertinib
Time frame: Up to 36 months after first dose
Stage 2, all cohorts: Plasma concentrations of furmonertinib and its major metabolite (AST5902)
Time frame: Up to 36 months after first dose
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 13 Mar 2026.
- 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.
Jamuna Thimmarayappa study director
ArriVent BioPharma
42 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Furmonertinib in people with Non-Small Cell Lung Cancer (NSCLC) and Metastatic Non-Small Cell Lung Cancer, run by ArriVent BioPharma, Inc. at 42 sites in 11 countries.
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 22 inclusion and 7 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 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in China, United States, Japan, Spain, Australia and 6 more countries. 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?
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?
Stage 1: Number of incidence and severity of adverse events (AEs) as a measure of safety and tolerability of Furmonertinib (time frame: Up to 36 months after first dose). The study lists 2 primary outcomes in all. 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 13 Mar 2026.