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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05364073




Registration number
NCT05364073
Ethics application status
Date submitted
6/04/2022
Date registered
6/05/2022
Date last updated
19/07/2024

Titles & IDs
Public title
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
Scientific 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
Secondary ID [1] 0 0
FURMO-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Small Cell Lung Cancer (NSCLC) 0 0
Metastatic Non-Small Cell Lung Cancer 0 0
Advanced Non-Small Cell Lung Cancer 0 0
HER2 Exon 20 Mutations 0 0
EGFR Exon 20 Mutations 0 0
EGFR Uncommon Mutations, Including G719X and S768I 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Furmonertinib
Treatment: Drugs - Furmonertinib
Treatment: Drugs - Furmonertinib
Treatment: Drugs - Furmonertinib
Treatment: Drugs - Furmonertinib

Experimental: Stage 1 Dose Escalation and Backfill - Experimental: Previously treated patients with advanced or metastatic NSCLC with activating EGFR or HER2 mutations

Experimental: Stage 2 Expansion Cohort 1 - Previously Treated NSCLC Patients with EGFR Exon 20 Insertion Mutations

Experimental: Stage 2 Expansion Cohort 2 - Previously treated NSCLC Patients with HER2 Exon 20 Insertion Mutations

Experimental: Stage 2 Expansion Cohort 3 - Previously treated NSCLC Patients with EGFR Activating Mutations, who are not eligible for Cohorts 1 and 4

Experimental: Stage 2 Expansion Cohort 4 - Untreated or Previously treated EGFR TKI Naïve NSCLC Patients with EGFR Uncommon Mutations, excluding EGFR exon 20 insertion mutations


Treatment: Drugs: Furmonertinib
Furmonertinib tablet

Treatment: Drugs: Furmonertinib
Furmonertinib tablet

Treatment: Drugs: Furmonertinib
Furmonertinib tablet

Treatment: Drugs: Furmonertinib
Furmonertinib tablet

Treatment: Drugs: Furmonertinib
Furmonertinib tablet
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Stage 1: Number of incidence and severity of adverse events (AEs) as a measure of safety and tolerability of Furmonertinib
Timepoint [1] 0 0
Up to 36 months after first dose
Primary outcome [2] 0 0
Stage 2: Overall Response Rate (ORR)
Timepoint [2] 0 0
Up to 36 months after first dose
Secondary outcome [1] 0 0
Stage 1: Overall Response Rate
Timepoint [1] 0 0
Up to 36 months after first dose
Secondary outcome [2] 0 0
Stage 1: Duration of Response (DOR)
Timepoint [2] 0 0
Up to 36 months after first dose
Secondary outcome [3] 0 0
Stage 1: Disease Control Rate
Timepoint [3] 0 0
Up to 36 months after first dose
Secondary outcome [4] 0 0
Stage 1: Progression Free Survival
Timepoint [4] 0 0
Up to 36 months after first dose
Secondary outcome [5] 0 0
Stage 1: Depth of Response
Timepoint [5] 0 0
Up to 36 months after first dose
Secondary outcome [6] 0 0
Stage 1: Overall survival
Timepoint [6] 0 0
Up to 36 months after first dose
Secondary outcome [7] 0 0
Stage 1: Central Nervous System ORR
Timepoint [7] 0 0
Up to 36 months after first dose
Secondary outcome [8] 0 0
Stage 1: Central Nervous System DOR
Timepoint [8] 0 0
Up to 36 months after first dose
Secondary outcome [9] 0 0
Stage 1: Plasma concentrations of furmonertinib and its major metabolite (AST5902)
Timepoint [9] 0 0
Up to 36 months after first dose
Secondary outcome [10] 0 0
Stage 1, Cohort 1, Backfill only: Plasma concentrations of furmonertinib and its major metabolite (AST5902)
Timepoint [10] 0 0
Up to 36 months after first dose
Secondary outcome [11] 0 0
Stage 1, Cohort 1, Backfill only: Plasma concentrations of midazolam and its metabolite (1-OH-midazolam)
Timepoint [11] 0 0
Up to 36 months after first dose
Secondary outcome [12] 0 0
Stage 2, all cohorts: Duration of Response
Timepoint [12] 0 0
Up to 36 months after first dose
Secondary outcome [13] 0 0
Stage 2, all cohorts: Disease Control Rate
Timepoint [13] 0 0
Up to 36 months after first dose
Secondary outcome [14] 0 0
Stage 2, all cohorts: Progression Free Survival
Timepoint [14] 0 0
Up to 36 months after first dose
Secondary outcome [15] 0 0
Stage 2, all cohorts: Depth of Response
Timepoint [15] 0 0
Up to 36 months after first dose
Secondary outcome [16] 0 0
Stage 2, all cohorts: Overall survival
Timepoint [16] 0 0
Up to 36 months after first dose
Secondary outcome [17] 0 0
Stage 2, all cohorts: Central Nervous System ORR
Timepoint [17] 0 0
Up to 36 months after first dose
Secondary outcome [18] 0 0
Stage 2, all cohorts: Central Nervous System DOR
Timepoint [18] 0 0
Up to 36 months after first dose
Secondary outcome [19] 0 0
Stage 2, Cohort 4 only: Overall Response Rate
Timepoint [19] 0 0
Up to 36 months after first dose
Secondary outcome [20] 0 0
Stage 2, all cohorts: Number of incidence and severity of AEs as a measure of safety and tolerability of Furmonertinib
Timepoint [20] 0 0
Up to 36 months after first dose
Secondary outcome [21] 0 0
Stage 2, all cohorts: Plasma concentrations of furmonertinib and its major metabolite (AST5902)
Timepoint [21] 0 0
Up to 36 months after first dose

Eligibility
Key inclusion criteria
Key

* 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.

Stage 1 Dose Escalation and Backfill Cohorts

- 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

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/06/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2025
Actual
Sample size
Target
170
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
ArriVent Investigative Site - Blacktown
Recruitment hospital [2] 0 0
ArriVent Investigative Site - St Leonards
Recruitment hospital [3] 0 0
ArriVent Investigative Site - Heidelberg
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment postcode(s) [3] 0 0
3084 - Heidelberg
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas
Country [6] 0 0
United States of America
State/province [6] 0 0
Virginia
Country [7] 0 0
Canada
State/province [7] 0 0
Edmonton
Country [8] 0 0
Canada
State/province [8] 0 0
Toronto
Country [9] 0 0
China
State/province [9] 0 0
Anhui
Country [10] 0 0
China
State/province [10] 0 0
Beijing
Country [11] 0 0
China
State/province [11] 0 0
Chongqing
Country [12] 0 0
China
State/province [12] 0 0
Guizhou
Country [13] 0 0
China
State/province [13] 0 0
Heilongjiang
Country [14] 0 0
China
State/province [14] 0 0
Henan
Country [15] 0 0
China
State/province [15] 0 0
Hubei
Country [16] 0 0
China
State/province [16] 0 0
Jiangsu
Country [17] 0 0
China
State/province [17] 0 0
Jianxi
Country [18] 0 0
China
State/province [18] 0 0
Jilin
Country [19] 0 0
China
State/province [19] 0 0
Shan Dong
Country [20] 0 0
China
State/province [20] 0 0
Shandong
Country [21] 0 0
China
State/province [21] 0 0
Shanghai
Country [22] 0 0
China
State/province [22] 0 0
Shanxi
Country [23] 0 0
France
State/province [23] 0 0
Lyon
Country [24] 0 0
France
State/province [24] 0 0
Toulouse
Country [25] 0 0
France
State/province [25] 0 0
Villejuif
Country [26] 0 0
Italy
State/province [26] 0 0
Medolla
Country [27] 0 0
Japan
State/province [27] 0 0
Chiba
Country [28] 0 0
Japan
State/province [28] 0 0
Osaka
Country [29] 0 0
Japan
State/province [29] 0 0
Tokyo
Country [30] 0 0
Korea, Republic of
State/province [30] 0 0
Gwangju
Country [31] 0 0
Korea, Republic of
State/province [31] 0 0
Seoul
Country [32] 0 0
Netherlands
State/province [32] 0 0
Noord-Holland
Country [33] 0 0
Spain
State/province [33] 0 0
Barcelona
Country [34] 0 0
Spain
State/province [34] 0 0
Madrid
Country [35] 0 0
Spain
State/province [35] 0 0
Valencia
Country [36] 0 0
United Kingdom
State/province [36] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
ArriVent BioPharma, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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 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).
Trial website
https://clinicaltrials.gov/study/NCT05364073
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Morgan Lam
Address 0 0
ArriVent BioPharma
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Nichole Baio
Address 0 0
Country 0 0
Phone 0 0
628-277-4836
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05364073