Ameile (aumolertinib) / Jiangsu Hansoh Pharma, Abdul Latif Jameel Health, Glenmark - LARVOL DELTA

First-line Aumolertinib (EGFR tyrosine kinase inhibitor) plus apatinib (VEGFR inhibitor) versus aumolertinib in EGFR-mutant non-small cell lung cancer patients: a randomized, multicenter, phase II trial. (PubMed, Signal Transduct Target Ther) - P3 | "Exploratory analysis revealed that PFS benefits from aumolertinib plus apatinib predominantly in those with TP53 mutations. As an infusion-free option, aumolertinib plus apatinib demonstrated PFS benefits with manageable safety in patients with untreated, EGFR-mutant, advanced NSCLC."

Clinical • Journal • P2 data • Cardiovascular • Hypertension • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • TP53

Epidemiological characteristics of EGFR-mutant resected NSCLC patients receiving aumolertinib as adjuvant treatment in China: A cross-sectional analysis of a nationwide dataset (ELCC 2026) - No abstract available

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

MRD Evaluation of Adjuvant Aumolertinib in stage IB and IA2-3 EGFR-Mutant NSCLC After Complete Surgical Resection: A Multicenter, Single-arm, Open-lable Study (ELCC 2026) - No abstract available

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

Efficacy and Safety of Double-Dose Aumolertinib in Advanced EGFR-Mutant NSCLC With Distinct Post–First-Line EGFR-TKI Progression Patterns: A Prospective, Open-Label, Multicenter Study (ELCC 2026) - No abstract available

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

Aumolertinib for AI-predicted EGFR-mutated pulmonary ground-glass nodules: a single-arm, phase II, CATO-2301 trial (ELCC 2026) - No abstract available

P2 data • Lung Cancer • EGFR

Adjuvant Aumolertinib in Resected EGFR-Mutated Stage IA2-ⅢA NSCLC: Updated Long-Term Outcomes from a Multicenter Real-World Study (ELCC 2026) - No abstract available

Clinical • Real-world • Real-world evidence • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • EGFR

A Prospective, Multicenter Phase II Study of ctDNA-Guided Individualized Therapy with Aumolertinib ± Chemotherapy in Advanced L858R EGFR+ NSCLC (ELCC 2026) - No abstract available

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

Aumolertinib plus oral etoposide (Lastet) as first-line treatment for EGFR-mutated, locally advanced or metastatic non-small cell lung cancer (NSCLC): The multicenter, phase II EVOLUTION study (ELCC 2026) - No abstract available

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

SHR-A2009, a HER3-targeted ADC, plus aumolertinib (A) as 1L or ≥2L treatment for EGFR-mutated (EGFRm) NSCLC: a phase 1b/2 study (ELCC 2026) - No abstract available

P1/2 data • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • EGFR • ERBB3

HS-10241 combined with aumolertinib in EGFR-TKIs pretreated EGFR-mutant and MET-amplified advanced NSCLC: a phase 1b study (ELCC 2026) - No abstract available

Metastases • P1 data • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • MET

High-Dose Aumolertinib in EGFR-Mutant NSCLC with Leptomeningeal Metastases: A Real-World Study Focusing on Poor Prognostic Subgroups (ELCC 2026) - No abstract available

Clinical • Real-world • Real-world evidence • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • EGFR

Aumolertinib plus Chemotherapy for NSCLC with EGFR and Concomitant Tumor Suppressor Genes (ACROSS 2): Phase III study (IASLC-WCLC 2025) - P3 | "Patients will be randomized (1:1) to receive aumolertinib once daily 110 mg plus carboplatin (AUC=5) and pemetrexed 500 mg/m2 Q3W or aumolertinib once daily 110 mg until disease progression. This multicenter, open-label, randomized, controlled, phase III study demonstrated that aumolertinib combined with platinum-pemetrexed showed a statistically significant in PFS compared to aumolertinib monotherapy. The safety profile were manageable."

P3 data • Anemia • Constipation • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Efficacy and Safety of Aumolertinib as Adjuvant Therapy in Resectable Stage I A EGFR Mutated NSCLC With High Risk (APPOINT) (IASLC-WCLC 2025) - P2 | "There were no grade ≥3 AE occurred during aumolertinib treatment group, and no new safety signals were observed. Conclusions : The data demonstrated that compared with the observation group, aumolertinib treatment group exhibited superior efficacy and safety in stage IA EGFR mutated NSCLC pts with high-risk pathological features, highlighting its clinical utility potential for EGFR mutated stage IA NSCLC management."

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

Neoadjuvant Aumolertinib for unresectable stage III EGFR-mutant non-small cell lung cancer: a single-arm phase II trial. (PubMed, Nat Commun) - P2 | "RNA-sequencing based analysis revealed increased infiltration of CD8 + T-cells in post-treatment tumors compared to baseline, particularly in responsive and Ex19-Del mutation tumors. Collectively, neoadjuvant Aumolertinib showed promising efficacy and a surgical conversion rate with a tolerable safety profile for unresecable NSCLCm in stage III, potentially involved in the remodeling of tumor microenvironment."

Journal • P2 data • Fatigue • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CD8 • EGFR

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

A Case of Refractory Pulmonary Enteric Adenocarcinoma with EGFR Sensitive Mutation (PubMed, Zhongguo Fei Ai Za Zhi) - "The patient showed no meaningful response to EGFR-tyrosine kinase inhibitors (EGFR-TKIs), including the first-generation (Icotinib), the second-generation (Afatinib) and the third-generation (Aumolertinib). Trophoblast cell surface antigen 2-antibody-drug conjugate (TROP2-ADC) and immune checkpoint inhibitors (ICIs) combined with Bevacizumab also resulted in limited efficacy. Based on the clinical features and treatment response of this case, we reviewed the published literature about the pathological characteristics, mutational landscape, and current therapeutic approaches for PEAC, with a particular focus on the therapeutic challenges and future research directions for EGFR-mutant PEAC, aiming to provide insights for clinical practice and further studies.."

IO biomarker • Journal • Colorectal Adenocarcinoma • Colorectal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • PD-L1

A Single-Arm, Open-Label Clinical Study of Aumolertinib Monotherapy as Long-Cycle Neoadjuvant Treatment for Stage IB-ⅢB EGFR-Positive Non-Small Cell Lung Cancer (ChiCTR) - P=N/A | N=30 | Not yet recruiting | Sponsor: The First Affiliated Hospital of Zhengzhou University; The First Affiliated Hospital of Zhengzhou University

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

Exploration of the Exposure Level of Aumolertinib and Its Correlation with Clinical Efficacy in Patients with Lung Cancer (ChiCTR) - P=N/A | N=50 | Not yet recruiting | Sponsor: Shanghai General Hospital; Shanghai General Hospital

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

Exploratory clinical study on preserving organs in patients with stage II-III non-small cell lung cancer(The Future Star) (ChiCTR) - P4 | N=598 | Recruiting | Sponsor: Jiangsu Cancer Hospital; Jiangsu Cancer Hospital

New P4 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • PD-L1

Aumolertinib Plus Anlotinib in Advanced NSCLC with Brain Metastasis: A Single-arm, Phase II Study (IASLC-WCLC 2023) - "In addition, EGFR-TKIs combined with bevacizumab can further improve the efficacy, as reported in study JO25567 and NEJ026. Aumolertinib plus anlotinib showed preliminary efficacy as first-line therapy in EGFR-mutant NSCLC patients with brain metastases. The initial subgroup results may demonstrated superior activity of aumolertinib plus anlotinib in patients with multiple intracranial metastases or EGFR 19Del positive. And although with comutations, NSCLC patients with brain metastasis can still benefit from aumolertinib plus anlotinib."

Metastases • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CCND1 • MET • PIK3CA • TP53

Almonertinib plus Anlotinib for EGFR Mutant NSCLC with Progression After Third-Generation TKI Adjuvant Therapy (ChiCTR) - P4 | N=50 | Recruiting | Sponsor: Tianjin Medical University Cancer Institute&Hospital; Tianjin Medical University Cancer Institute&Hospital

New P4 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A study evaluating the efficacy and safety of aumolertinib mesylate as first-line therapy in patients with EGFR-mutated stage IIIB-IV non-squamous non-small cell lung cancer (NSCLC) complicated by chronic obstructive pulmonary disease (COPD) (ChiCTR) - P=N/A | N=51 | Not yet recruiting | Sponsor: Tianjin Chest Hospital; Tianjin Chest Hospital

New trial • Chronic Obstructive Pulmonary Disease • Immunology • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor • EGFR

Aumolertinib with or without chemotherapy as first line treatment in locally advanced or metastatic NSCLC with sensitizing EGFR mutations (AENEAS2) (AACR 2025) - P3 | "AENEAS2 (NCT04923906) is a randomized, open-label, multicenter, phase 3 study assessing the efficacy and safety of aumolertinib plus chemotherapy versus aumolertinib alone as first-line treatment in locally advanced or metastatic NSCLC with sensitizing EGFR mutations. Patients who were naïve to treatment with locally advanced or metastatic NSCLC harboring EGFR mutations (exon 19 deletion or L858R mutation) were randomly assigned in a 1:1 ratio to receive aumolertinib 110 mg QD in combination with pemetrexed (500 mg/m2) plus cisplatin (75 mg/m2) or carboplatin (AUC5), versus to receive aumolertinib 110 mg QD monotherapy. Aumolertinib plus chemotherapy as a first-line treatment in advanced EGFR-mutant NSCLC demonstrated a statistically significant and clinically meaningful PFS improvement over aumoletinib monotherapy, with a manageable safety profile."

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

Prospective Phase II Single-Arm Study of Induction Therapy with Aumolertinib and Chemotherapy in Potentially Resectable Stage Ⅲ EGFR-Mutant Non-Squamous NSCLC (ChiCTR) - P2 | N=20 | Not yet recruiting | Sponsor: Sichuan Cancer Hospital; Sichuan Cancer Hospital

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

Aumolertinib as adjuvant therapy in patients with stage II-IIIB EGFR-mutated NSCLC after complete tumor resection: A randomized, double-blind, placebo-controlled, phase 3 trial (ARTS) (AACR 2025) - P3 | "Adjuvant aumolertinib demonstrates a statistically significant and clinically meaningful improvement in DFS in patients with stage II-IIIB EGFRm NSCLC following complete tumor resection and adjuvant chemotherapy, when indicated. This DFS benefit underscores the promise of aumolertinib in fulfilling an unmet need for effective adjuvant EGFR-targeted therapy in early-stage NSCLC."

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