NCT04905550

Almonertinib Combined With Cerebral Radiation Treat Brain Metastases From EGFR Positive NSCLC

An Exploratory Clinical Study of Almonertinib in Combination With Craniocerebral Radiotherapy in First-line Treatment of EGFR Positive Non-Small Cell Lung Cancer(NSCLC) With Brain Metastases

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Chongqing University Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

According to literature reports, about 16.3%-19% of newly diagnosed NSCLC patients are associated with brain metastasis, and 30%-50% of NSCLC patients will develop brain metastasis during the whole course of the disease. Patients with EGFR positive-type had a 10-15% higher risk of brain metastasis than patients with EGFR wild-type. mOS in patients with EGFR positive were twice as high as those with EGFR wild-type, despite the presence of brain metastasis. Improving the control rate of intracranial lesions in patients with EGFR positive can not only improve the quality of life, but also may translate into survival benefits and improve OS. Previous studies have shown that in lung cancer patients with EGFR-sensitive mutations, craniocerebral radiotherapy prior to delayed craniocerebral radiotherapy significantly prolonged OS. The first-line treatment of the third generation of EGFR-TKI targeting drug Almonertinib for EGFR-positive NSCLC can eliminate the possible EGFR T790M mutant clones at an early stage and better control the disease progression. Moreover, Almonertinib is easy to pass through the blood-brain barrier, which can not only better control intracranial lesions, but also control, prevent or delay the occurrence of brain metastasis. This study was intended to conduct a randomized controlled study on the safety and efficacy of early craniocerebral radiotherapy combined with Almonertinib in patients with EGFR positive non-small cell lung cancer with brain metastasis. Through the above studies we hope to confirm that early craniocerebral radiotherapy combined with Almonertinib is safe and feasible for patients with EGFR positive newly diagnosed with brain metastasis, and can prolong the intracranial progression-free survival (IPFS), and even extend the progression-free survival (PFS) and overall survival (OS).

Detailed description

All eligible patients will receive craniocerebral radiotherapy in combination with Almonertinib. Here are two types of craniocerebral radiotherapy: 1. SRS or SRT is recommended for patients with ≤4 intracranial metastases and the maximum lesion ≤4cm. 24-15 Gy\*1F was recommended if use SRS. 9-12 Gy\*3F or 6Gy×5F was recommended if use SRT. 2. For \>4 intracranial metastases, or the maximum lesion\>4cm, whole-brain radiotherapy (WBRT) of 30Gy/10F was recommended, and then the large residual lesions will be treated with a local dose (≤DT 45Gy/15F). Hippocampal protection is highly recommended.

Conditions

• Non-Small Cell Lung Cancer (NSCLC)

Interventions

Type	Name	Description
DRUG	Almonertinib	Almonertinib 110mg p.o qd. Treatment with Almonertinib will continue until progression or unacceptable toxicity.
RADIATION	Stereotactic Radiotherapy(SRT) or Stereotactic Radiosurgery(SRS) or Whole-Brain Radiotherapy(WBRT)	Image guided, 24-15 Gy\*1F was recommended if use SRS. 9-12 Gy\*3F/1W or 6Gy×5F/1W was recommended if use SRT. 30Gy/10F/2W for WBRT, large residual lesions will be treated with a local dose (≤DT 45Gy/15F).

Timeline

• Start date: 2021-03-01
• Primary completion: 2024-03-01
• Completion: 2024-08-01
• First posted: 2021-05-27
• Last updated: 2021-06-02

Locations

1 site across 1 country: China