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NSCLCPhase 2NCT07413952

Limertinib Plus Radiotherapy for EGFR-Mutant NSCLC With Brain Metastases

A Phase 2 study testing Limertinib Plus Radiotherapy in people with NSCLC, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
NSCLC
What is being tested?
Limertinib Plus Radiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteChina
Study dates
1 Apr 2026to 31 Dec 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • ≥3 primary brain lesions, with at least one lesion ≥2 cm. Patients must not have received any prior systemic anti-cancer treatment for advanced/metastatic non-small cell lung cancer, including standard chemotherapy, biological therapy, targeted therapy, immunotherapy, or investigational drug therapy. Patients who have received adjuvant or neoadjuvant therapy (chemotherapy and/or radiotherapy) are eligible if no disease progression occurred within 6 months after completion of treatment. Patients who have received local treatment (radiotherapy or pleural perfusion therapy) are also eligible if the treated lesions are not target lesions.
  • 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).
  • Male patients with reproductive potential and female patients who may become pregnant must use highly effective contraceptive methods during the study and for 12 months after treatment discontinuation.

Who cannot join

  • 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.
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  • 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.
  • Patients with serious acute or chronic medical or psychiatric conditions, as determined by the investigator, that may increase the risks associated with study participation or interfere with the interpretation of study results.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jiexia Zhang, Prof. contact

+8613903056432

drzjxcn@126.com

China1 site

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

    Guangzhou

    Jiexia Zhang, Prof., +8613903056432, drzjxcn@126.com

Other trials in China

About this study

Official title: 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

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.

Conditions
NSCLC
Being tested
Limertinib Plus Radiotherapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Limertinib Plus RadiotherapyDrug

    Limertinib Plus Radiotherapy

Study groups in NCT07413952
Study groupRoleWhat they receive
Limertinib Plus RadiotherapyExperimentalNot described
Receives: Drug: Limertinib Plus Radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Intracranial progression-free survival (iPFS)

    Intracranial progression-free survival (iPFS) is defined as the time from the initiation of study treatment to the first documented intracranial disease progression or death from any cause, whichever occurs first, as assessed by magnetic resonance imaging (MRI) according to RECIST version 1.1 criteria.

    Measured: Up to 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2026
  2. Study start1 Apr 2026 (estimated)
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07413952
Sponsor's protocol ID
NSCLC 002
Status last verified
Feb 2026
First submitted
10 Feb 2026
Last updated
17 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Limertinib Plus Radiotherapy in people with NSCLC, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jiexia Zhang, Prof. (+8613903056432, drzjxcn@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intracranial progression-free survival (iPFS) (time frame: Up to 36 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07413952.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.

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