2022 World Conference on Lung Cancer (ePosters)-EP08.02-077. Two Phase III Trials of Aumolertinib Plus Chemotherapy for NSCLC with EGFR and Concomitant non-EGFR Driver Genes /Tumor Suppressor Genes

EP08.02-077. Two Phase III Trials of Aumolertinib Plus Chemotherapy for NSCLC with EGFR and Concomitant non-EGFR Driver Genes /Tumor Suppressor Genes

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Two phase III clinical trials, known as ACROSS 1 and ACROSS 2, are being conducted to evaluate the effectiveness and safety of aumolertinib, a third-generation EGFR tyrosine-kinase inhibitor (TKI), in combination with chemotherapy as a first-line treatment for patients with advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR-concomitant mutations. The trials are open-label, randomized, and controlled, and are currently enrolling patients in China.<br /><br />EGFR-TKIs are commonly used to treat NSCLC patients with EGFR mutations, but their efficacy is limited in patients with EGFR concomitant mutations. The BENEFIT study demonstrated that combining EGFR-TKI with chemotherapy improved outcomes compared to EGFR-TKI alone in patients with concomitant tumor suppressor genes or multiple driver genes.<br /><br />Aumolertinib has been approved in China as a treatment for NSCLC patients with EGFR mutations. The primary objective of the ACROSS trials is to assess the progression-free survival (PFS) of patients receiving aumolertinib alone versus aumolertinib plus chemotherapy. Secondary endpoints include objective response rate (ORR), disease control rate (DCR), duration of response (DoR), overall survival (OS), and safety.<br /><br />The trials will include patients aged 18-75 years with stage IIIB-IV NSCLC, an ECOG performance status of 0-1, and confirmed EGFR-sensitive mutations along with non-EGFR active gene or tumor suppressor gene co-mutations. Patients with asymptomatic central nervous system metastases will also be eligible.<br /><br />The efficacy of aumolertinib will be evaluated based on PFS according to RECIST v1.1 criteria, while safety will be assessed using the incidence and severity of adverse events, as well as clinical chemistry, hematology, and other measures.<br /><br />Enrollment for the trials began in July 2021, and the estimated completion date is in the third quarter of 2024. The studies are being sponsored by Jiangsu Hansoh Pharmaceutical Group Co., Ltd. More information about the trials can be found on the clinicaltrials.gov website using the NCT numbers NCT04500704 and NCT04500717.

Asset Subtitle

Jie Wang

Meta Tag

Speaker Jie Wang

Topic Metastatic Non-small Cell Lung Cancer - Molecular Targeted Treatments

Keywords

ACROSS trials

aumolertinib

EGFR tyrosine-kinase inhibitor

chemotherapy

non-small cell lung cancer

EGFR-concomitant mutations

BENEFIT study

progression-free survival

objective response rate

safety