Brief Summary
Global, Phase 3, randomized, multicenter, open-label study evaluating the efficacy and safety of furmonertinib (firmonertinib) at 2 dose levels (160 mg once daily \[QD\] and 240 mg QD) compared to platinum-based chemotherapy in previously untreated patients with locally advanced or metastatic non-squamous Non-Small Cell Lung Cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) exon 20 insertion mutations. A target of approximately 375 patients will be randomized in a 1:1:1 ratio to treatment with furmonertinib 240 mg QD, furmonertinib 160 mg QD, or platinum-based chemotherapy.
Brief Title
Study to Compare Furmonertinib to Platinum-Based Chemotherapy for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Mutations (FURVENT)
Categories
Completion Date
Completion Date Type
Estimated
Conditions
Metastatic Non-Small Cell Lung Cancer
Advanced Non-Small Cell Lung Cancer
EGFR Exon 20 Mutations
Eligibility Criteria
Key Inclusion Criteria:
* Histologically or cytologically documented, locally advanced or metastatic non-squamous Non-Small Cell Lung Cancer (NSCLC) not amenable to curative surgery or radiotherapy.
* Documented results of the presence of an Epidermal Growth Factor Receptor (EGFR) exon 20 insertion mutation in tumor tissue or blood from local or central testing.
* No prior systemic anticancer therapy regimens received for locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) including prior treatment with any Epidermal Growth Factor Receptor (EGFR)-targeting agents (e.g., previous (EGFR) TKIs, monoclonal antibodies, or bispecific antibodies).
* Patients who have received prior neo-adjuvant and/or adjuvant chemotherapy, immunotherapy, or chemo radiotherapy for non-metastatic disease (excluding EGFR-TKIs) must have experienced a treatment free interval of at least 12 months.
* Patients with a history of treated CNS metastases or new asymptomatic CNS metastases are eligible.
* Histologically or cytologically documented, locally advanced or metastatic non-squamous Non-Small Cell Lung Cancer (NSCLC) not amenable to curative surgery or radiotherapy.
* Documented results of the presence of an Epidermal Growth Factor Receptor (EGFR) exon 20 insertion mutation in tumor tissue or blood from local or central testing.
* No prior systemic anticancer therapy regimens received for locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) including prior treatment with any Epidermal Growth Factor Receptor (EGFR)-targeting agents (e.g., previous (EGFR) TKIs, monoclonal antibodies, or bispecific antibodies).
* Patients who have received prior neo-adjuvant and/or adjuvant chemotherapy, immunotherapy, or chemo radiotherapy for non-metastatic disease (excluding EGFR-TKIs) must have experienced a treatment free interval of at least 12 months.
* Patients with a history of treated CNS metastases or new asymptomatic CNS metastases are eligible.
Inclusion Criteria
Key Inclusion Criteria:
* Histologically or cytologically documented, locally advanced or metastatic non-squamous Non-Small Cell Lung Cancer (NSCLC) not amenable to curative surgery or radiotherapy.
* Documented results of the presence of an Epidermal Growth Factor Receptor (EGFR) exon 20 insertion mutation in tumor tissue or blood from local or central testing.
* No prior systemic anticancer therapy regimens received for locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) including prior treatment with any Epidermal Growth Factor Receptor (EGFR)-targeting agents (e.g., previous (EGFR) TKIs, monoclonal antibodies, or bispecific antibodies).
* Patients who have received prior neo-adjuvant and/or adjuvant chemotherapy, immunotherapy, or chemo radiotherapy for non-metastatic disease (excluding EGFR-TKIs) must have experienced a treatment free interval of at least 12 months.
* Patients with a history of treated CNS metastases or new asymptomatic CNS metastases are eligible.
* Histologically or cytologically documented, locally advanced or metastatic non-squamous Non-Small Cell Lung Cancer (NSCLC) not amenable to curative surgery or radiotherapy.
* Documented results of the presence of an Epidermal Growth Factor Receptor (EGFR) exon 20 insertion mutation in tumor tissue or blood from local or central testing.
* No prior systemic anticancer therapy regimens received for locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) including prior treatment with any Epidermal Growth Factor Receptor (EGFR)-targeting agents (e.g., previous (EGFR) TKIs, monoclonal antibodies, or bispecific antibodies).
* Patients who have received prior neo-adjuvant and/or adjuvant chemotherapy, immunotherapy, or chemo radiotherapy for non-metastatic disease (excluding EGFR-TKIs) must have experienced a treatment free interval of at least 12 months.
* Patients with a history of treated CNS metastases or new asymptomatic CNS metastases are eligible.
Gender
All
Gender Based
false
Keywords
Non-Small Cell Lung Cancer (NSCLC)
Exon 20
Furmonertinib
Firmonertinib
AST2818
FURMO-004
Drug-Therapy
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT05607550
Org Class
Industry
Org Full Name
ArriVent BioPharma, Inc.
Org Study Id
FURMO-004
Overall Status
Active, not recruiting
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
A Global, Phase 3, Randomized, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Furmonertinib Compared to Platinum-Based Chemotherapy as First-Line Treatment for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Mutations (FURVENT)
Primary Outcomes
Outcome Measure
Progression Free Survival (PFS) determined by blinded independent central review (BICR)
Outcome Time Frame
Up to 32 months after first dose
Secondary Ids
Secondary Id
2022-502977-41-00
Secondary Outcomes
Outcome Time Frame
Up to 62 months after first dose
Outcome Measure
Overall Survival (OS)
Outcome Time Frame
Up to 36 months after first dose
Outcome Measure
PFS determined by investigator assessment
Outcome Time Frame
Up to 36 months after first dose
Outcome Measure
Overall response rate (ORR)
Outcome Time Frame
Up to 36 months after first dose
Outcome Measure
Duration of response (DOR)
Outcome Time Frame
Up to 36 months after first dose
Outcome Measure
Time to second Progression Free Survival (PFS2)
Outcome Time Frame
Up to 36 months after first dose
Outcome Measure
PFS by blinded independent central review (BICR) in patients with a history or presence of brain metastases at baseline
Outcome Time Frame
Randomization up to ≤30 days after last dose
Outcome Measure
Time to central nervous system (CNS) metastases by BICR
Outcome Time Frame
Randomization up to ≤30 days after last dose
Outcome Measure
CNS ORR evaluated by BICR
Outcome Time Frame
Randomization up to ≤30 days after last dose
Outcome Measure
CNS DOR evaluated by BICR
Outcome Time Frame
Randomization up to ≤30 days after last dose
Outcome Measure
CNS PFS evaluated by BICR
Outcome Description
QLQ-C30 is a cancer-specific questionnaire comprised of 5 functional scales (physical, role, cognitive, emotional, and social functioning); 3 symptom scales (fatigue, pain, and nausea/vomiting); and a global health status/quality-of-life (QoL) scale. Six single-item scales are also included (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties).
Outcome Time Frame
Randomization up to ≤30 days after last dose
Outcome Measure
Change in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (QLQ-C30)
Outcome Description
QLQ-LC13 is a cancer-specific questionnaire which comprises of 13 questions assessing lung cancer-associated symptoms (cough, hemoptysis, dyspnea, and site-specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy, and alopecia), and use of pain medication.
Outcome Time Frame
Randomization up to ≤30 days after last dose
Outcome Measure
Change in EORTC QLQ Lung Cancer Module Core 13 (QLQ LC13)
Outcome Description
NSCLC-SAQ consists of 7 items assessing 5 NSCLC symptom concepts: cough, pain, dyspnea, fatigue, and poor appetite.
Outcome Time Frame
Randomization up to ≤30 days after last dose
Outcome Measure
Change in Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC SAQ)
Outcome Time Frame
Up to 36 months after first dose
Outcome Measure
Number of incidence and severity of adverse events (AEs) as a measure of safety and tolerability of Furmonertinib
Outcome Time Frame
Up to 36 months after first dose
Outcome Measure
Plasma concentrations of furmonertinib and its major metabolite (AST5902)
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Balazs Halmos
Investigator Email
bahalmos@montefiore.org