Study to Compare Furmonertinib to Platinum-Based Chemotherapy for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

• Sponsor: ArriVent BioPharma, Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05607550
• Collaborator: Allist Pharmaceuticals, Inc. (Industry)
• Enrollment: 375
• Locations: 38
• Arms: 3
• Anticipated Duration (Months): 62
• Patients Per Site: 9.9
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

Global, Phase 3, randomized, multicenter, open-label study evaluating the efficacy and safety of furmonertinib 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 NSCLC with 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.

Condition or Disease	Intervention/Treatment	Phase
Non-Small Cell Lung Cancer; Carcinoma, Non-Small-Cell Lung; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Antineoplastic Agents; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Protein Kinase Inhibitors	Drug: furmonertinib 240 mg; Drug: furmonertinib 160 mg; Drug: platinum-based chemotherapy	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 375 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 With Epidermal Growth Factor Receptor Exon 20 Insertion Mutations
• Anticipated Study Start Date: Dec 15, 2022
• Anticipated Primary Completion Date: Aug 15, 2025
• Anticipated Study Completion Date: Feb 15, 2028

Arms and Interventions

Arm	Intervention/Treatment
Experimental: furmonertinib 240 mg furmonertinib tablet	Drug: furmonertinib 240 mg; furmonertinib tablet; Other Names: AST2818
Experimental: furmonertinib 160 mg furmonertinib tablet	Drug: furmonertinib 160 mg; furmonertinib tablet; Other Names: AST2818
Active Comparator: platinum-based chemotherapy carboplatin or cisplatin based on investigator's choice + pemetrexed intravenously	Drug: platinum-based chemotherapy; (carboplatin or cisplatin based on investigator's choice) + pemetrexed intravenously (IV)

Outcome Measures

Primary Outcome Measures

1. Progression Free Survival (PFS) determined by blinded independent central review (BICR) [Up to 32 months after first dose]

Secondary Outcome Measures

1. Overall Survival (OS) [Up to 62 months after first dose]

2. PFS determined by investigator assessment [Up to 36 months after first dose]

3. Overall response rate (ORR) [Up to 36 months after first dose]

4. Duration of response (DOR) [Up to 36 months after first dose]

5. Time to second Progression Free Survival (PFS2) [Up to 36 months after first dose]

6. PFS by blinded independent central review (BICR) in patients with a history or presence of brain metastases at baseline [Up to 36 months after first dose]

7. Time to central nervous system (CNS) metastases by BICR [Randomization up to ≤30 days after last dose]

8. CNS ORR evaluated by BICR [Randomization up to ≤30 days after last dose]

9. CNS DOR evaluated by BICR [Randomization up to ≤30 days after last dose]

10. CNS PFS evaluated by BICR [Randomization up to ≤30 days after last dose]

11. Change in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (QLQ-C30) [Randomization up to ≤30 days after last dose]

    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).

12. Change in EORTC QLQ Lung Cancer Module Core 13 (QLQ LC13) [Randomization up to ≤30 days after last dose]

    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.

13. Change in Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC SAQ) [Randomization up to ≤30 days after last dose]

    NSCLC-SAQ consists of 7 items assessing 5 NSCLC symptom concepts: cough, pain, dyspnea, fatigue, and poor appetite.

14. Number of incidence and severity of adverse events (AEs) as a measure of safety and tolerability of Furmonertinib [Up to 36 months after first dose]

15. Plasma concentrations of furmonertinib and its major metabolite (AST5902) [Up to 36 months after first dose]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Key Inclusion Criteria:

• Histologically or cytologically documented, locally advanced or metastatic non-squamous NSCLC not amenable to curative surgery or radiotherapy.

• Documented validated results confirming the presence of an 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 NSCLC including prior treatment with any 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 chemoradiotherapy for non-metastatic disease 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arrivent Investigative Site	Yuma	Arizona	United States	85364
2	Arrivent Investigative Site	Fayetteville	Arkansas	United States	72703
3	Arrivent Investigative Site	Fullerton	California	United States	92835
4	Arrivent Investigative Site	Long Beach	California	United States	90806
5	Arrivent Investigative Site	Napa	California	United States	94558
6	Arrivent Investigative Site	San Diego	California	United States	92123
7	Arrivent Investigative Site	Santa Barbara	California	United States	93105
8	Arrivent Investigative Site	Santa Rosa	California	United States	95403
9	Arrivent Investigative Site	Whittier	California	United States	90602
10	Arrivent Investigative Site	Hartford	Connecticut	United States	06102
11	Arrivent Investigative Site	Fort Lauderdale	Florida	United States	33308
12	Arrivent Investigative Site	Ocala	Florida	United States	34474
13	Arrivent Investigative Site	Peoria	Illinois	United States	61615
14	Arrivent Investigative Site	Indianapolis	Indiana	United States	46250
15	Arrivent Investigative Site	Bethesda	Maryland	United States	20817
16	Arrivent Investigative Site	Frederick	Maryland	United States	21702
17	Arrivent Investigative Site	Rockville	Maryland	United States	20850
18	Arrivent Investigative Site	Fairhaven	Massachusetts	United States	02719
19	Arrivent Investigative Site	Lansing	Michigan	United States	48912
20	Arrivent Investigative Site	Bolivar	Missouri	United States	65613
21	Arrivent Investigative Site	Saint Joseph	Missouri	United States	64507
22	Arrivent Investigative Site	Omaha	Nebraska	United States	68130
23	Arrivent Investigative Site	Englewood	New Jersey	United States	07631
24	Arrivent Investigative Site	Florham Park	New Jersey	United States	07932
25	Arrivent Investigative Site	Goldsboro	North Carolina	United States	27534
26	Arrivent Investigative Site	Cincinnati	Ohio	United States	45220
27	Arrivent Investigative Site	Tulsa	Oklahoma	United States	74146
28	Arrivent Investigative Site	Salem	Oregon	United States	97301
29	Arrivent Investigative Site	Gettysburg	Pennsylvania	United States	17325
30	Arrivent Investigative Site	Greenville	South Carolina	United States	29607
31	Arrivent Investigative Site	Sioux Falls	South Dakota	United States	57117
32	ArriVent Investigative Site	Memphis	Tennessee	United States	38120
33	Arrivent Investigative Site	Dallas	Texas	United States	75230
34	Arrivent Investigative Site	Houston	Texas	United States	77030
35	Arrivent Investigative Site	Ogden	Utah	United States	84405
36	Arrivent Investigative Site	Salt Lake City	Utah	United States	84106
37	ArriVent Investigative Site	Fairfax	Virginia	United States	22031
38	Arrivent Investigative Site	Tacoma	Washington	United States	98405

Sponsors and Collaborators

• ArriVent BioPharma, Inc.
• Allist Pharmaceuticals, Inc.

Investigators

• Study Director: Morgan Lam, ArriVent BioPharm

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ArriVent BioPharma, Inc.
• ClinicalTrials.gov Identifier: NCT05607550
• Other Study ID Numbers: FURMO-004
• First Posted: Nov 7, 2022
• Last Update Posted: Dec 16, 2022
• Last Verified: Dec 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by ArriVent BioPharma, Inc.: NSCLC; Metastatic Non-Small Cell Lung Cancer; Advanced Non-Small Cell Lung Cancer; EGFR; Exon 20 Insertion Mutations; EGFR kinase domain mutations; Exon 20; EGFR Exon 20 Insertion Mutations; Tyrosine Kinase Inhibitor (TKI); Platinum-based chemotherapy; Chemotherapy; Cisplatin; Carboplatin; Pemetrexed; Furmonertinib
• Additional relevant MeSH terms: Carcinoma; Lung Neoplasms; Neoplasms; Carcinoma, Non-Small-Cell Lung; Neoplasms by Site; Respiratory Tract Neoplasms; Bronchial Neoplasms; Carcinoma, Bronchogenic; Lung Diseases; Respiratory Tract Diseases; Aflutinib

Study Results

No Results Posted as of Dec 16, 2022