Ivesa (firmonertinib)
/ Allist, ArriVent
- LARVOL DELTA
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July 31, 2026
160Mgfurmonertinib for EGFR-Mutated NSCLC With Leptomeningeal Metastases: A Prospective Single-Arm Study
(IASLC-WCLC 2026)
- P2 | "Common TRAEs included rash, oral ulceration, diarrhea, decreased appetite, leukopenia, and anemia. Conclusions : Furmonertinib with or without intrathecal pemetrexed demonstrated promising efficacy in EGFR-mutated NSCLC patients with leptomeningeal metastases, with an overall manageable safety profile."
Clinical • Leukopenia • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • EGFR
July 31, 2026
Phase2 Study ofHigh-Dose Furmonertinib Plus Bevacizumab and Intrathecal Pemetrexed in Egfrmnsclc Withleptomeningeal Metastases
(IASLC-WCLC 2026)
- P2 | "Conclusions : High-dose furmonertinib combined with bevacizumab and intrathecal pemetrexed showed promising efficacy and tolerable safety in patients with EGFR mutated NSCLC and LMs. Dynamic monitoring of CSF ctDNA could predict treatment efficacy and prognosis in patients with LMs."
P2 data • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • EGFR
July 01, 2024
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
July 17, 2026
Updated efficacy and early on-treatment ctDNA dynamics of firmonertinib plus anlotinib as first-line treatment for advanced EGFR L858R-mutant NSCLC: A phase II trial
(ESMO 2026)
- No abstract available
Circulating tumor DNA • Clinical • Metastases • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR
July 31, 2026
ALPACCA: Ph3 Trial of Firmonertinib vs Investigator's Choice of EGFRI as 1L Treatment for Locally Advanced or mNSLC With EGFR PACC Mutations
(IASLC-WCLC 2026)
- P3 | "Treatment options include EGFR tyrosine kinase inhibitors (TKIs) (osimertinib, afatinib) and chemotherapy.EGFR PACC mutations comprise approximately 12.5% of all NSCLC EGFR mutations (Robichaux et al 2021, Nilsson et al 2024). Key secondary endpoints include OS, investigator assessed PFS and ORR, and safety and tolerability. Enrollment is ongoing."
Metastases • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • EGFR
July 31, 2026
Furmonertinib Combined with Intraventricular Chemotherapy in Third-Generation EGFR-TKI Resistant Leptomeningeal Metastases
(IASLC-WCLC 2026)
- "Conclusions : The combination of high-dose furmonertinib and intraventricular pemetrexed represents an effective and tolerable salvage regimen for EGFR-mutant NSCLC with LM after failure of third-generation TKIs. CSF ctDNA analysis provides a highly sensitive prognostic tool, underscoring the clinical utility of this biomarker in disease monitoring."
Lung Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor
July 31, 2026
A Prospective, Multicenter Phase Ib/II Study of Vebreltinib Plus Firmonertinib in EGFR-TKI-Refractory c-Met-Amplified NSCLC
(IASLC-WCLC 2026)
- "Conclusions : This study demonstrates that the combination of vebreltinib and firmonertinib represents a promising therapeutic strategy for patients with EGFR-mutant, c-Met-amplified NSCLC who have progressed after EGFR-TKI failure. The safety profile of this combination regimen was acceptable and manageable."
Clinical • P1/2 data • Leukopenia • Lung Cancer • Non Small Cell Lung Cancer • Pruritus • Solid Tumor • MET
September 09, 2026
Neoadjuvant Therapy With Firmonertinib Combined With Anlotinib and Platinum-Based Doublet Chemotherapy for Resectable EGFR-Mutated NSCLC
(clinicaltrials.gov)
- P2 | N=29 | Not yet recruiting | Sponsor: Hubei Cancer Hospital
New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR
September 16, 2026
Efficacy and Safety of Zorifertinib Combined with Double-Dose Furmonertinib and Pemetrexed Intrathecal Chemotherapy in Treating EGFR-Mutant Non-Small Cell Lung Cancer with Leptomeningeal Metastasis: A Single-Arm, Prospective Clinical Study
(ChiCTR)
- P=N/A | N=60 | Not yet recruiting | Sponsor: Nanjing Drum Tower Hospital; Nanjing Drum Tower Hospital
New trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR
July 31, 2026
Combined EGFR-TKI, BRAF and MEK Inhibitors Treatment for Advanced Non-Small-Cell Lung Cancer Patients With an Acquired BRAF V600E Mutation, Report Of5cases
(IASLC-WCLC 2026)
- "Among them, five patients were treated with furmonertinib, dabrafenib, and trametinib.Two patients achieved progression-free survival (PFS) of 6 and 8 months after full-dose treatment...Discussion : Two cucessful cases with a PFS longer than 6months after the progression on osimertinib are both with young age and good PS...Dual EGFR/BRAF inhibition further enhances antitumor activity, though it is associated with a significantly higher incidence and severity of adverse events. Given this risk-benefit trade-off, such treatment strategies require further clinical investigation to optimize safety, tolerability, and long-term outcomes."
Clinical • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor
July 31, 2026
Firmonertinib (160 mg)Combined With Chemotherapy as First-Line Treatment for Advanced NSCLC Patients With EGFR Mutations and CNS Metastases
(IASLC-WCLC 2026)
- "Conclusions : Firmonertinib (160mg)combined with pemetrexed and platinum-based chemotherapy demonstrated promising clinical efficacy and manageable toxicity in EGFR-mutated NSCLC patients with CNS metastases. These findings support its potential as a viable first-line treatment option for this patient population."
Clinical • Metastases • Leukopenia • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • EGFR • TP53
September 15, 2026
P-Loop/αC-Helix Compressing Mutations and Exon 20 Insertions in EGFR-Mutant NSCLC: A Rapidly Evolving Therapeutic Landscape.
(PubMed, J Clin Oncol)
- "EGFR PACC and ex20ins are established subgroups of kinase domain mutations, distinct from classical mutations, due to structure and responsiveness to available TKIs."
Journal • Review • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR
September 02, 2026
A Study of SKB571 Combination Therapy in Participants With Non-Small Cell Lung Cancer (NSCLC)
(clinicaltrials.gov)
- P2 | N=150 | Recruiting | Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting
Enrollment open • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor
July 17, 2026
High-dose furmonertinib combined with bevacizumab and pemetrexed in patients with EGFR-mutated NSCLC and LM: An ambispective real-world study
(ESMO 2026)
- No abstract available
Clinical • Real-world • Real-world evidence • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR
April 21, 2026
Firmonertinib combined with platinum-based chemotherapy in patients with EGFR-mutant advanced NSCLC following disease progression on first-line third-generation EGFR-TKI.
(ASCO 2026)
- P2 | "Study treatment was firmonertinib (160 mg once daily) with chemotherapy (pemetrexed [500 mg/m2] plus either cisplatin [75 mg/m2] or carboplatin [AUC 5]). Firmonertinib combined with chemotherapy showed promising antitumor activity with a manageable safety profile in pts with EGFR-mutant advanced NSCLC following disease progression on first-line 3rd-generation EGFR-TKIs."
Clinical • Metastases • Hematological Disorders • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor
July 17, 2026
Efficacy and safety of firmonertinib for residual ground-glass nodules after surgery in EGFR-sensitizing multiple primary lung cancer: a prospective randomized study
(ESMO 2026)
- No abstract available
Clinical • Surgery • Lung Cancer • Oncology • Solid Tumor • EGFR
July 17, 2026
Molecular dynamics and mechanisms of acquired resistance in NSCLC patients with EGFR PACC mutations treated with firmonertinib
(ESMO 2026)
- No abstract available
Clinical • Preclinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR
July 17, 2026
Efficacy and Safety of Firmonertinib 160mg Combined with Intrathecal Injection in NSCLC Patients with EGFR Mutations and Leptomeningeal Metastases
(ESMO 2026)
- No abstract available
Clinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR
July 17, 2026
Updated efficacy and safety of adjuvant Firmonertinib in completely resected stage IA (with high-risk factors) and IB EGFR-mutated NSCLC: Extended follow-up of the phase II FAME study
(ESMO 2026)
- No abstract available
Clinical • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR
September 16, 2026
Trastuzumab Rezetecan in Combination with Furmonertinib for the Treatment of Non‑Small Cell Lung Cancer with HER‑2 Overexpression After Progression on EGFR‑TKIs
(ChiCTR)
- P2 | N=39 | Not yet recruiting | Sponsor: The second affiliated hospital of Zhejiang University school of medicine; The second affiliated hospital of Zhejiang University school of medicine
New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor
July 31, 2026
ECTOP-1031 Trial: Updated Analysis of First-Line Firmonertinib 160 mg in EGFRmut/PD-L1+ Locally Advanced or Metastatic NSCLC
(IASLC-WCLC 2026)
- "Grade≥3 treatment-related adverse events (TRAEs) were observed in 6.5% of patients, mainly including ALT elevation, hepatic dysfunction and elevated myocardial enzymes. Conclusions : The ECTOP-1031 study demonstrates that double-dose firmonertinib offers promising efficacy and a manageable safety profile as first-line treatment in patients with EGFR-mutant and PD-L1-positive advanced NSCLC."
Clinical • IO biomarker • Metastases • Hepatology • Liver Failure • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • EGFR • PD-L1
July 31, 2026
Firmonertinib as Adjuvant Therapy for Completely Resected Stage IA2-IA3 With High-Risk Factors and IB NSCLC Patients With EGFR Mutations
(IASLC-WCLC 2026)
- P=N/A, P3 | "Conclusions : Firmonertinib 80mg orally once daily has shown potential efficacy and excellent safety as adjuvant therapy for completely resected stage IA2-IA3 with high-risk factors and IB NSCLC patients with EGFR mutations. Patients were well tolerated and the TRAEs were consistent with previous studies."
Clinical • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • EGFR
July 31, 2026
High MPR/pCR Rates With Neoadjuvant Firmonertinib ± Chemotherapy in Resectable EGFR-Mutant NSCLC: A Multicenter Study
(IASLC-WCLC 2026)
- "Conclusions : Neoadjuvant firmonertinib-based therapy demonstrated high pathologic response rates, favorable surgical feasibility, and manageable toxicity in resectable EGFR-mutant NSCLC. The numerically greater pathologic activity observed with firmonertinib plus chemotherapy supports prospective evaluation of this neoadjuvant strategy."
Clinical • Leukopenia • Lung Cancer • Non Small Cell Lung Cancer • Renal Disease • Solid Tumor • EGFR
September 13, 2026
National Utilization of Navigation and Robotics in Inpatient Spinal Fusion Remains Low but is Increasing, 2016-2022.
(PubMed, Global Spine J)
- "Study DesignRetrospective cohort study.ObjectivesAdoption patterns in spinal fusion remain poorly defined at the national level...Although adoption remained modest, robotics expanded at a steeper trajectory than navigation. Despite observed differences in unadjusted complication profiles across cohorts, these findings should be interpreted cautiously given likely selection bias and unmeasured case complexity, and prospective studies are needed to determine long-term outcomes."
Journal
July 31, 2026
The Preliminary Data of Double-Dose Firmonertinib as First-Line Therapy for EGFR+ NSCLC Complicated With MPE (FRUIT-D Study)
(IASLC-WCLC 2026)
- "No new safety signals were observed. Conclusions : For patients with NSCLC-MPE harboring EGFR mutations, we speculate that the double-dose firmonertinib may be a more rational first-line treatment option for this patient population."
Clinical • Lung Cancer • Non Small Cell Lung Cancer • Respiratory Diseases • Solid Tumor • EGFR
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