NCT05379803 is a Phase 2 clinical trial of Furmonertinib in Non-Small Cell Lung Cancer, sponsored by Hunan Province Tumor Hospital.

Who is sponsoring NCT05379803?

NCT05379803 is sponsored by Hunan Province Tumor Hospital.

What drugs are being tested in NCT05379803?

Interventions in NCT05379803: Furmonertinib.

What condition does NCT05379803 study?

NCT05379803 studies Non-Small Cell Lung Cancer.

Is NCT05379803 still recruiting?

NCT05379803 is currently recruiting now. Last updated 19 September 2024.

Last reviewed 2024-09-19 · How we verify

NCT05379803

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

High-dose Furmonertinib for First-line Treatment of EGFR Mutated NSCLC With Central Nervous System (CNS) Metastases

Recruiting now Phase 2 Last updated 19 September 2024

What this trial tests

Phase 2 trial testing Furmonertinib in Non-Small Cell Lung Cancer in 40 participants. Currently enrolling.

Timeline

1 May 2022

Primary endpoint
31 December 2024

31 March 2025

Quick facts

Lead sponsor	Hunan Province Tumor Hospital
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	1 May 2022
Primary completion	31 December 2024
Estimated completion	31 March 2025
Sites	1 location across China

Drugs / interventions tested

Furmonertinib — full drug profile →

Conditions studied

Non-Small Cell Lung Cancer — all drugs for Non-Small Cell Lung Cancer →

Sponsor

Hunan Province Tumor Hospital

Who can join

18 and older, any sex, with Non-Small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

EGFR mutated NSCLC patiens with CNS metastases have poor prognosis. High-dose furmonertinib (160mg/day) have produced high CNS PFS and ORR in second-line for EGFR T790M mutated NSCLC. Whether EGFR mutated NSCLC with CNS metastases can benefit from first-line treatment of high-dose furmonertinib has not been reported. This study aims to investigate the efficacy and safety of high dose furmonertinib in first-line treatment of EGFR mutated NSCLC patiens.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

Spotlight on Furmonertinib (Alflutinib, AST2818). The Swiss Army Knife (del19, L858R, T790M, Exon 20 Insertions, "uncommon-G719X, S768I, L861Q") Among the Third-Generation EGFR TKIs?
Zhang SS, Ou SI. · · 2022 · cited 22× · PMID 36317157 · DOI 10.2147/lctt.s385437
Central nervous system efficacy of furmonertinib (AST2818) in patients with EGFR T790M mutated non-small cell lung cancer: a pooled analysis from two phase 2 studies.
Hu X, Zhang S, Ma Z, Feng J, et al · · 2023 · cited 16× · PMID 37118803 · DOI 10.1186/s12916-023-02865-z
First report of furmonertinib as a first-line treatment in advanced lung adenocarcinoma patients harboring EGFR exon 20 insertion mutations after the kinase domain αC-helix: Two case reports and a literature review.
Han H, Zhang X, Liu X, Zhao J, et al · · 2023 · cited 6× · PMID 38206746 · DOI 10.1097/md.0000000000036667
Clinical Features, Molecular Biology, and the Metastatic Microenvironment in Lung Cancer Brain Metastases: Implications for Treatment Decisions.
Zhu Y, He D, Hou Z, Lan M, et al · · 2025 · cited 2× · PMID 40719284 · DOI 10.1002/advs.202502626
The current landscape, advancements, and prospects in the treatment of patients with EGFR exon 20 insertion mutations warrant scientific elucidation.
Man X, Sun X, Chen C, Xiang Y, et al · · 2024 · cited 2× · PMID 38919530 · DOI 10.3389/fonc.2024.1367204

Verify or expand the search:

Other trials of Furmonertinib

Trials testing the same drug.

NCT07482605 — Furmonertinib Plus Radiotherapy for EGFR+ NSCLC With Pleural Effusion · Phase 2 · not yet recruiting
NCT07304739 — Furmonertinib Combined With Intrathecal Chemotherapy and Stereotactic Radiotherapy (SRT) for EGFR-Mutated NSCLC Patients · Phase 2 · recruiting
NCT07193160 — Sacituzumab Tirumotecan in Combination With Furmonertinib as Second-line Treatment for EGFR-mutant Advanced or Metastati · Phase 2 · not yet recruiting
NCT06674343 — Furmonertinib 160mg as First-line Treatment in Locally Advanced or Metastatic NSCLC With EGFR Classical Mutations · Phase 3 · recruiting
NCT06319950 — High-dose Furmonertinib Versus Osimertinib in Advanced EGFRm NSCLC Patients With Brain Metastases · Phase 2 · not yet recruiting

Other recruiting trials for Non-Small Cell Lung Cancer

Currently open trials in the same condition.

NCT07140315 — DK222 Study at Hopkins · Phase 1 · recruiting
NCT07487883 — Cadherin 3(CDH3)-Targeted PET in Lung Malignant Tumors · recruiting
NCT07413757 — CHOICE:Decision Factor of EGFR-TKI in Chinese IV NSCLC · recruiting
NCT07460999 — Singing Training vs Usual Care 6-18 Months After Surgical Resection for Non-small Cell Lung Cancer (NSCLC) · NA · recruiting
NCT07479277 — Progel Platinum for Air Leak Reduction After VATS Lobectomy for NSCLC · NA · recruiting

Other Hunan Province Tumor Hospital trials

Trials by the same sponsor.

NCT06706219 — Efficacy and Safety of Sacituzumab Tirumotecan (SKB264) in Combination With Toripalimab in Patients With Initially Unres · Phase 2 · not yet recruiting
NCT07001995 — Limertinib Plus Carboplatin and Etoposide for EGFR-mutant NSCLC With SCLC Transformation After EGFR-TKI Progression · Phase 2 · not yet recruiting
NCT07477808 — Megestrol Acetate for First-Line Treatment of Malnourished Non-Small Cell Lung Cancer · Phase 3 · not yet recruiting
NCT07251582 — Effect of Infusion Timing on Pathologic Response to Neoadjuvant Immunotherapy in Resectable Non-Small Cell Lung Cancer · Phase 3 · recruiting
NCT06477055 — The Recurrence Gene Profiles of Adjuvant Osimertinib Therapy in Resected Non-Small-Cell Lung Cancer · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05379803 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Hunan Province Tumor Hospital
Last refreshed: 19 September 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05379803.

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