Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Disease Progression

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Patients With Brain metastases of EGFR-mutant Non-small Cell Lung Cancer should receive Aumolertinib as upfront treatment. SRT(32Gy/4fx) is given to progressive or recurrent intracranial lesions as salvage therapy after intracranial failure.

Aumolertinib 110 mg p.o. qd+ SRT(32Gy/4fx)

Aumolertinib Oral Tablet

JIAYAN CHEN

Jiayan Chen, MD

About 20%-40% of NSCLC patients develop intracranial metastases, and most clinical studies suggest that the survival of lung cancer patients will be significantly shortened once they develop intracranial metastases. EGFR tyrosine kinase inhibitors (EGFR-TKIs) remain the standard first-line therapy for patients with advanced EGFR-mutated NSCLC, including brain metastases(EGFR BMs). The survival rate of NSCLC patients with EGFR BMs was significantly improved compared with that of mutation-free patients. Third-generation EGFR-TKIs have unique advantages in the treatment of NSCLC BMs due to their improved blood-brain barrier permeability, and with the development of radiotherapy technology, stereotactic radiation therapy (SRT) has also demonstrated its remarkable qualities of high efficiency and low toxicity in a limited number of intracranial metastases. The clinical mechanisms of resistance to third-generation EGFR-TKIs are far more complex than those of first-generation TKIs, and the treatment paradigm for disease progression including intracranial progression is challenging. It would be interesting to design prospective clinical studies of patients with EGFR BMs treated with the third-generation TKIs followed by salvage SRT for oligo-progression. Therefore, the investigator designed this prospective, phase II clinical study of intracranial oligo-progression applied with stereotactic radiotherapy as salvage therapy in EGFR BMs patients after failure of the third-generation EGFR-TKIs.

Efficacy of SRT as Salvage Therapy in Patients With Brain Oligo-progression of EGFR-mutant Non-small Cell Lung Cancer After Failure of the Third-generation EGFR-TKIs

Efficacy of SRT as Salvage Therapy in Patients With Brain Oligo-progression of EGFR-mutant Non-small Cell Lung Cancer After Failure of the Third-generation EGFR-TKIs: A Multicenter, Open Label, Phase II Clinical Study

the rate at which intracranial lesions experience complete and partial remission compared to baseline

the time between receiving treatment, observing intracranial disease progression or occurrence of death from any cause, two orders of iPFS will be available in this study analysis. Patients who are still alive at the time of analysis will have the date of their last contact as the cut-off date.

the time between receiving treatment, observing disease progression at any site, or occurrence of death from any cause, there will be two orders of PFS available for analysis in this study. Patients who are still alive at the time of analysis will have the date of their last contact as their cut-off date.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Efficacy of SRT as Salvage Therapy in Patients With Brain Oligo-progression of EGFR-mutant Non-small Cell Lung Cancer After Failure of the Third-generation EGFR-TKIs	NCT04519983	Lung Cancer Sta...	Aumolertinib Or...	15 Years - 75 Years	Shanghai Cancer Hospital, China
Efficacy of SRT as Salvage Therapy in Patients With Brain Oligo-progression of EGFR-mutant Non-small Cell Lung Cancer After Failure of the Third-generation EGFR-TKIs	NCT04519983	Lung Cancer Sta...	Aumolertinib Or...	15 Years - 75 Years	Shanghai Cancer Hospital, China

Spots Global Cancer Trial Database for aumolertinib oral tablet