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Limertinib Plus Radiotherapy for EGFR-Mutant NSCLC With Brain Metastases | Clinical Trials | Clareo Health

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Limertinib Plus Radiotherapy for EGFR-Mutant NSCLC With Brain Metastases

Efficacy and Safety of Limertinib (ASK120067) Combined With Radiotherapy as First-Line Treatment in Patients With EGFR-Mutant Non-Small Cell Lung Cancer and Brain Metastases: A Single-Arm, Multicenter, Prospective Phase II Study

NCT07413952•The First Affiliated Hospital of Guangzhou Medical University

View on ClinicalTrials.gov

Summary

Patients with epidermal growth factor receptor (EGFR)-mutant non-small-cell lung cancer (NSCLC) with brain metastases remain a major clinical challenge. Although EGFR-TKIs have demonstrated intracranial activity, disease control is still suboptimal in some patients. Limertinib (ASK120067) is a novel third-generation EGFR tyrosine kinase inhibitor with favorable central nervous system penetration and encouraging intracranial antitumor activity. The potential synergistic effect of limertinib combined with radiotherapy warrants further investigation. This prospective, multicenter, single-arm phase II study aims to evaluate the efficacy and safety of first-line limertinib combined with radiotherapy in this patient population.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients must voluntarily agree to participate in this study and sign a written informed consent form.
•Patients aged 18-75 years. Patients must have histologically or cytologically confirmed advanced non-small cell lung cancer (NSCLC), staged as IV according to the 9th edition of the American Joint Committee on Cancer (AJCC) TNM staging system.
•Histological or cytological reports issued by nationally accredited hospitals or third-party testing institutions confirming the presence of EGFR classical mutations (19Del \& 21L858R).
•ECOG PS score of 0-1, and an estimated survival of ≥3 months, as determined by the investigator.
•Brain metastases (meningeal/parenchymal) confirmed by CT or MRI, with or without symptoms.
•Patients must have at least one measurable lesion according to RECIST 1.1 criteria.
•Patients must meet the following organ function criteria:
•Absolute neutrophil count (ANC) ≥1.5×10⁹/L. 2) Platelet count ≥100×10⁹/L. 3) Hemoglobin (HGB) ≥90 g/L. 4) Serum total bilirubin (TBIL) ≤1.5× upper limit of normal (ULN). For patients with liver metastases, TBIL may be up to 3× ULN.
•5\) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5× ULN. For patients with liver metastases, AST and ALT may be up to 5× ULN.
•6\) Serum creatinine (SCr) ≤1.5× ULN, or creatinine clearance ≥50 mL/min (calculated using the Cockcroft-Gault formula).
+1 more criteria

Exclusion Criteria

•Patients unable to confirm a diagnosis of non-small cell lung cancer (NSCLC) through histological or cytological examination.
•Patients expected to require other systemic anti-cancer treatments outside of this study during the trial period.
•Patients diagnosed with malignant tumors within the past 2 years, except for well-controlled cutaneous basal cell carcinoma, cervical carcinoma in situ, or ductal carcinoma in situ of the breast.
•Patients with significant gastrointestinal diseases that may affect drug intake or absorption, including but not limited to peptic ulcer disease or inflammatory bowel disease.
•Patients with known or suspected hypersensitivity to the study interventions (lielitinib and radiotherapy) or components of study-related preparations.
•Patients who have previously received any epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) therapy.
•Patients who have used strong CYP3A4 inhibitors or inducers within 7 days prior to the first dose of study drug, or who are expected to require long-term use of these medications during the trial. Additionally, patients who have used traditional Chinese medicine or preparations with anti-tumor indications within 2 weeks prior to the first dose of study drug, or who are expected to require such use during the trial, will also be excluded.
•Patients with a history of interstitial lung disease, drug-induced interstitial lung disease, or radiation pneumonitis requiring corticosteroid treatment. Patients with acute exacerbation or progressive pulmonary symptoms at baseline, or those considered unsuitable for inclusion by the investigator due to high-risk factors for interstitial lung disease, will also be excluded.
•Patients with significant arrhythmia (e.g., QT interval \>470 ms) or heart failure (left ventricular ejection fraction \<50%).
•Pregnant or lactating women. Patients currently participating in or who have participated in other clinical trials within the past 4 weeks.
+1 more criteria

Locations (1)

The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong

Guangzhou, China

Key Dates

Start Date

April 1, 2026

Primary Completion Date

December 31, 2027

Completion Date

December 31, 2029

Last Updated

February 17, 2026

Enrollment

ESTIMATED participants

Conditions

NSCLC

Interventions

Limertinib Plus Radiotherapy

DRUG

Contacts

Jiexia Zhang, Prof.

CONTACT

+8613903056432 drzjxcn@126.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 17, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Limertinib Plus Radiotherapy for EGFR-Mutant NSCLC With Brain Metastases

Inclusion Criteria

Exclusion Criteria

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

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