Ivesa (firmonertinib) / Allist, ArriVent - LARVOL DELTA

Phase II study of firmonertinib in patients with previously treated advanced/metastatic non-small cell lung cancer (mNSCLC) with EGFR exon 20 insertion (ex20ins) mutations (ESMO 2025) - P2, P3 | "These results support firmo as a valuable treatment option for this pts population. Firmo is also under evaluation in a global, randomized Ph III trial for 1L NSCLC pts w/ex20ins (FURVENT; NCT05607550) and has completed enrollment."

Clinical • EGFR exon 20 • Metastases • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Furmonertinib in EGFR-mutated NSCLC with or without CNS metastasis: A systematic review and meta-analysis (ELCC 2026) - No abstract available

Retrospective data • Review • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • EGFR

First-line oral vinorelbine plus furmonertinib in refractory epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC): a multicenter, non-randomized, two-cohort study (ELCC 2026) - No abstract available

Clinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Firmonertinib plus 4 cycles platinum-pemetrexed as first-line treatment for EGFR-mutant locally advanced or metastatic NSCLC(FLAMES): Study design and preliminary outcomes (ELCC 2026) - No abstract available

Clinical • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • EGFR

Prolonged survival in EGFR exon 20 insertion mutant lung adenocarcinoma: case report of sequential osimertinib and furmonertinib with research trend analysis. (PubMed, Front Med (Lausanne)) - "This analysis demonstrated a growing global research focus on third-generation EGFR-TKIs and variant-specific treatment strategies for EGFR ex20ins-mutant NSCLC, supporting the rationale underpinning the therapeutic approach adopted in this report. Sequential high-dose third-generation EGFR-TKIs may offer clinically meaningful benefit in selected EGFR ex20ins cases; however, this strategy remains non-standard and should be regarded as hypothesis-generating, warranting further prospective evaluation."

IO biomarker • Journal • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • ETV6 • PD-L1 • SETD2 • SMAD4 • TP53

Exploration of the Efficacy and Safety of metronomic chemotherapy with vinorelbine capsules combined with third-generation EGFR-TKI as First-Line Treatment in Elderly Patients with Advanced Non-Small Cell Lung Cancer with EGFR Mutations (ChiCTR) - P=N/A | N=66 | Not yet recruiting | Sponsor: Beijing hospital; Beijing hospital

New trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • PD-L1

Favorable response to third-generation TKI furmonertinib in a patient with early-stage non-small cell lung cancer​ harboring rare compound EGFR mutations: Exon 18 G719C and Exon 20 S768I - A Case Report. (PubMed, Front Oncol) - "Here, we describe a case of early-stage non-small cell lung cancer (NSCLC) harboring a G719C+S768I compound mutation that achieved complete remission following treatment with furmonertinib. These findings suggest that furmonertinib may represent a promising therapeutic option to improve cure rates in this subset of patients."

Journal • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Zipalertinib-A Novel Treatment Opportunity for Non-Small Cell Lung Cancers with Exon 20 Insertions and Uncommon EGFR Mutations. (PubMed, Cancers (Basel)) - "The role and the integration of therapies targeting exon20ins or uncommon mutations into the first- and second-line treatment armamentarium for NSCLC patients is not yet fully established, and the therapeutic impact of monotherapies (e.g., sunvozertinib, firmonertinib) versus combinations with standard platinum-based chemotherapy (e.g., zipalertinib, amivantamab) currently still lacks robust evidence to further change the therapeutic landscape for these patients. Therefore, results from the ongoing trials are eagerly awaited and are expected to shed some light on these open questions."

Journal • Review • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

A Single-Arm, Multicenter, Phase II Clinical Trial of Firmonertinib in Combination With Definitive Radiotherapy for Patients With Stage III Unresectable Pulmonary Adenocarcinoma Harboring Positive EGFR Uncommon Driver Mutations (ChiCTR) - P2 | N=15 | Not yet recruiting | Sponsor: Hunan Cancer Hospital; Hunan Cancer Hospital

New P2 trial • Lung Adenocarcinoma • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Neoadjuvant 160mg Furmonertinib and Cisplatin/Pemetrexed in EGFR Mutated Stage II-IIIB Resectable NSCLC: A prospective multicenter single-arm clinical study (ChiCTR) - P2 | N=27 | Not yet recruiting | Sponsor: Army Medical Center of PLA; Army Medical Center of PLA

New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

A Multicenter Exploratory Clinical trail （BEACON）of Furmonertinib Combined with Chemotherapy or Furmonertinib Monotherapy as First-Line Treatment for Patients with EGFR-Mutated Advanced Non-Small Cell Lung Cancer (NSCLC) with Brain Metastases (ChiCTR) - P=N/A | N=60 | Completed | Sponsor: Dongguan People's Hospital; Dongguan People's Hospital

New trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Pulsatile High-dose Furmonertinib in EGFR-mutant NSCLC with Leptomeningeal Metastasis (ChiCTR) - P=N/A | N=42 | Not yet recruiting | Sponsor: Guangdong Provincial Hospital of Traditional Chinese Medicine; Guangdong Provincial Hospital of Traditional Chinese Medicine

New trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

The Design for a Phase II, Randomized, Multicenter Study of CtDNA-Guided Treatment With Furmonertinib Combined Therapy or Furmonertinib Alone for Untreated Advanced EGFR Mutant Non-small-cell Lung Cancer Patients: The FOCUS-C Study. (PubMed, Clin Lung Cancer) - P2 | "This study will evaluate the efficacy and tolerability of furmonertinib plus carboplatin and pemetrexed with or without bevacizumab verses furmonertinib alone in untreated patients with advanced EGFR mutant NSCLC without EGFR clearance."

Circulating tumor DNA • Clinical • Journal • Metastases • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Furmonertinib 160mg vs 80mg + Chemotherapy in EGFR-Mutated NSCLC With Brain Metastases: Efficacy and Safety Study (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: Tianjin Medical University Cancer Institute and Hospital

New P2 trial • Brain Cancer • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Case Report: Furmonertinib-induced acute interstitial lung disease. (PubMed, Front Pharmacol) - "Through timely diagnosis and appropriate intervention, the patient achieved a favorable outcome. This case highlights that early recognition and management can reverse this serious adverse event and help preserve subsequent treatment options."

Journal • Infectious Disease • Interstitial Lung Disease • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pneumonia • Pulmonary Disease • Respiratory Diseases • Solid Tumor

Furmonertinib in lung adenocarcinoma with EGFR exon 20 insertion mutation: A case report of positive outcome. (PubMed, Medicine (Baltimore)) - "Furmonertinib, as a third-generation EGFR-TKI, demonstrated substantial efficacy in patients with advanced EGFR20ins-mutant NSCLC, significantly extending PFS and improving quality of life. This drug offers a promising new treatment option for patients with resistance to conventional therapies. Further studies will help validate the application of furmonertinib in a broader patient population."

Journal • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Furmonertinib versus gefitinib in treatment-naïve EGFR mutated non-small cell lung cancer: A randomized, double-blind, multi-center, phase III study (FURLONG) (ELCC 2022) - P3 | "The median duration of exposure was 18.3 months in the furmonertinib group and 11.2 months in the gefitinib group, whereas the frequency of grade≥3 treatment-related adverse events (TRAEs) was 11% in the furmonertinib group and 18% in the gefitinib group. Conclusions Furmonertinib significantly prolonged PFS and showed less grade≥3 TRAEs compared with gefitinib as first-line treatment in advanced EGFR mutated NSCLC patients."

Clinical • P3 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

A Phase 1b Study Of Furmonertinib, an Oral, Brain Penetrant, Selective EGFR Inhibitor, in Patients with Advanced NSCLC with EGFR Exon 20 Insertions (IASLC-WCLC 2023) - P1, P3 | "Furmonertinib showed promising efficacy and a predictable and manageable safety profile in patients with NSCLC harboring EGFR Exon20ins mutations. Based on these results, a global registrational Phase III study in first-line patients with locally advanced or metastatic NSCLC with EGFR Exon20ins mutations has been initiated (FURVENT/FURMO-004; NCT05607550)."

Clinical • EGFR exon 20 • Metastases • P1 data • Dental Disorders • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Stomatitis

FURTHER: A Global, Randomized Study of Firmonertinib at Two Dose Levels in TKI-Naive, Advanced NSCLC with EGFR PACC Mutations (IASLC-WCLC 2024) - P1 | "FURTHER is the first clinical trial to evaluate a TKI, firmonertinib, specifically in NSCLC patients with EGFR PACC mutations. Firmonertinib shows promising efficacy in NSCLC patients across a broad range of EGFR PACC mutations in the first-line metastatic setting with CNS antitumor activity and acceptable safety. Further investigation of firmonertinib in NSCLC patients with EGFR PACC mutations is warranted."

Clinical • Metastases • CNS Tumor • Dental Disorders • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Stomatitis • EGFR

High-dose Furmonertinib in patients with EGFR-mutated non-small cell lung cancer and leptomeningeal metastases: A prospective real-world study. (PubMed, J Thorac Oncol) - "In the real world, the high-dose furmonertinib-based treatment may potentially have clinical efficacy and tolerable safety in patients of EGFR-mutated NSCLC with LM, even in patients previously treated with other third-generation EGFR-TKIs. Methylation and CNB analysis of cfDNA in CSF may be considered objective indicators for the diagnosis of LM and evaluation of treatment response."

Journal • Real-world • Real-world evidence • Leukopenia • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Double-dose firmonertinib as first-line treatment in patients with locally advanced or metastatic non-small-cell lung cancer harboring EGFR L858R mutation: a prospective, multicenter, phase II study (FIRM). (PubMed, Nat Commun) - P2 | "Baseline circulating tumor DNA (ctDNA) variant allele frequency predicts ctDNA clearance at cycle 3 day 1, which correlates with longer PFS. Double-dose firmonertinib shows promising efficacy and tolerability, supporting its preliminary potential as first-line treatment for EGFR L858R-mutated advanced NSCLC."

Journal • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Pulsatile High-dose Furmonertinib in EGFR-mutant NSCLC With Leptomeningeal Metastasis (clinicaltrials.gov) - P=N/A | N=42 | Not yet recruiting | Sponsor: Guangzhou University of Traditional Chinese Medicine

New trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Efficacy and Safety of Firmonertinib Plus Anlotinib as First-Line Treatment for Advanced NSCLC With EGFR Mutations: A Single-Arm, Phase I/II Trial. (PubMed, Clin Lung Cancer) - "Firmonertinib plus anlotinib demonstrated preliminary efficacy and manageable safety as first-line treatment among patients with NSCLC harboring EGFR mutations."

Journal • P1/2 data • Cardiovascular • Hypertension • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • TP53

Firmonertinib Combined With Definitive Radiotherapy in Stage III Unresectable EGFR Uncommon Mutant Pulmonary Adenocarcinoma (clinicaltrials.gov) - P2 | N=15 | Not yet recruiting | Sponsor: Hunan Cancer Hospital

New P2 trial • Lung Adenocarcinoma • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

EGFR p.V774M/p. the S768I Compound Mutation in NSCLC Is a Good Prognostic Marker for IPHC- and Furmonertinib-Based Treatment: A Case Report. (PubMed, Cancer Rep (Hoboken)) - "The EGFR p.V774M/p.The S768I mutation contributed to improving the efficiency of furmonertinib-based therapy for NSCLC."

Biomarker • Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Respiratory Diseases • Solid Tumor • EGFR