Clinical trial NCT04778800: A Dose Exploration Study of Almonertinib for EGFRm NSCLC Patients With Brain/Leptomeningeal Metastasis (ARTISTRY)
Official title: A Dose Exploration Study of Almonertinib for Epidermal Growth Factor Receptor(EGFR)-Mutant Non-small-cell Lung Cancer(NSCLC) Patients With Newly Diagnosed or Recurrent Brain/Leptomeningeal Metastasis (ARTISTRY)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: NSCLC
Brain Metastases
Leptomeningeal Metastasis
Lead sponsor: Henan Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2021-03-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Almonertinib is a three-generation epidermal growth factor receptor tyrosine kinase inhibitor(EGFR-TKI), which has shown competitive potential in the second-line treatment against first-generation TKIs. This study aims to explore the efficacy and safety of different doses of almonertinib in the first-line and second-line treatment of brain metastases/meningeal metastases in NSCLC patients.


Eligibility criteria: Inclusion Criteria:

Queue 1

1. Male or female,age at least 18 years ;
2. Histologically confirmed patients with NSCLC brain metastases (including patients who have relapsed after previous treatment or newly diagnosed);
3. There must be at least one measurable brain lesion that has not been locally treated at the time of enrollment;
4. Patients who have not received other systemic treatment after the diagnosis of NSCLC brain metastasis, or patients who have received neoadjuvant therapy, adjuvant therapy, concurrent radiotherapy and chemotherapy, and local radiotherapy for more than 6 months;
5. Tumor tissue samples or blood are confirmed to be EGFR sensitive mutations (including exon 19 deletion or L858R) by ARMS;
6. The Eastern Cooperative Oncology Group (ECOG) physical status score is 0-2 and has not deteriorated in the previous 2 weeks, with a minimum expected survival of 12 weeks;
7. The patient is not required to have measurable systemic lesions; if there is, the lesions are required to be in at least one dimension (the largest diameter recorded by non-nodular lesions and the short axis of nodular lesions) ≥10mm by conventional techniques (CT, MRI) Can be accurately measured under the circumstances;
8. The subject himself voluntarily participated and signed an informed consent form.

Queue 2

1. Male or female,age at least 18 years ;
2. Histologically confirmed NSCLC patients (including patients who have relapsed after previous treatment or newly diagnosed);
3. Tumor cells found in cerebrospinal fluid or MRI showed clear meningeal enhancement and patients with dizziness/headache were included as selection criteria;
4. Patients who have not received other systemic treatment after being diagnosed with stage IV NSCLC, or patients who have received neoadjuvant therapy, adjuvant therapy, and concurrent radiotherapy and chemotherapy for more than 6 months;
5. The tumor tissue samples or blood are confirmed to be EGFR sensitive mutations (including exon 19 deletion or L858R) by ARMS;
6. The Eastern Cooperative Oncology Group (ECOG) physical status score is 0-2 and has not deteriorated in the previous 2 weeks, with a minimum expected survival of 12 weeks;
7. The patient is not required to have measurable systemic lesions; if there is, the lesions are required to be in at least one dimension (the largest diameter recorded by non-nodular lesions and the short axis of nodular lesions) ≥10mm by conventional techniques (CT, MRI) Can be accurately measured under the circumstances; The subjects themselves participated voluntarily and signed a written informed consent form.

Queue 3

1. Male or female,age at least 18 years ;
2. Histologically confirmed patients with stage IV NSCLC (including relapsed or newly diagnosed stage IV patients after previous treatment);
3. Patients with brain progression or brain lesions that have not resolved after the first/second generation EGFR-TKI treatment;
4. The patient must have at least one measurable brain lesion that has not been locally treated at the time of enrollment;
5. The tumor tissue samples or blood are confirmed to be EGFR sensitive mutations (including exon 19 deletion or L858R) by ARMS;
6. The Eastern Cooperative Oncology Group (ECOG) physical status score is 0-2 and has not deteriorated in the previous 2 weeks, with a minimum expected survival of 12 weeks;
7. The patient is not required to have measurable systemic lesions; if there is, the lesions are required to be in at least one dimension (the largest diameter recorded by non-nodular lesions and the short axis of nodular lesions) ≥10mm by conventional techniques (CT, MRI) Can be accurately measured under the circumstances;
8. The subject himself voluntarily participated and signed an informed consent form.

Exclusion Criteria:

1. the researchers believe that the risks faced by patients after entering the group are greater than those who benefit from them.
2. patients involved in any other clinical study.
3. patients with other malignant tumors.
4. A history of allergic reactions caused by compounds similar to almonertinib or its chemical composition.
5. pregnant or lactating women.
6. researchers should not participate in the study if they believe that patients cannot comply with the research procedures and requirements.

Primary outcomes:
measure: iPFS
timeFrame: Up to approximately 3 years after the last patient is randomized
Secondary outcomes:
measure: DCR
timeFrame: Up to approximately 3 years after the last patient is randomized
measure: PFS
timeFrame: Up to approximately 3 years after the last patient is randomized
measure: OS
timeFrame: Up to approximately 3 years after the last patient is randomized
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
Study officials:
affiliation: Henan Cancer Hospital
name: Huijuan Wang, MD
role: PRINCIPAL_INVESTIGATOR
References: