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Armatinib Alone or in Combination With SRT for Brain Metastases EGFR-mutated Non-small Cell Lung Cancer

Study Purpose

Objective:Patients with asymptomatic or minimally symptomatic Stage IV EGFR-positive NSCLC with baseline intracranial metastases. Aim: To investigate the timing, efficacy and safety of radiotherapy in patients with EGFR positive brain metastases treated with armatinib alone or combined with stereotactic radiotherapy. Method: Almonertinib: specification 55mg/tablet; The dosage is 110 mg / day (2 tablets / day) orally once a day; SBRT: 3-5 doses of 27-40 Gy

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. aged 18 years or older (including 18 years) and up to 75 years (including 75 years) 2. histologically confirmed NSCLC (by AJCC 8th edition lung cancer staging criteria) 3. asymptomatic or minimally symptomatic brain metastases (i.e., headache, nausea, or seizures responding to dexamethasone/analgesic/antiepileptic agents at a stable drug dose for at least 3 days); 4. brain metastases must meet the following criteria on diagnostic MRI: at least one lesion that can be classified as measurable disease according to RANO-BM, ≤ 10 brain or brainstem metastases. 5. epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 (L858R) substitution mutation (alone or in combination with other EGFR mutations); 6. no prior systemic therapy other than neoadjuvant therapy, adjuvant therapy, or concurrent chemotherapy for more than 3 months prior to study entry. 7. Eastern Cooperative Oncology Organization Group (ECOG) physical status score of 0 or 1 and no worsening in the previous 2 weeks, with a minimum expected survival of 12 weeks. 8. good hematopoietic function, defined as absolute neutrophil count ≥ 1.5 × 109 /L, platelet count ≥ 100 × 109 /L, and hemoglobin ≥ 90 g/L [no transfusion or erythropoietin (EPO-dependent) within 7 days. 9. good coagulation, defined as an international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN; if the subject is on anticoagulation therapy, as long as the PT is within the proposed range of anticoagulant medication. 10. good liver function, defined as a total bilirubin level ≤ 1.5 times the upper limit of normal (ULN); glutathione transaminase (AST) and glutamate transaminase (ALT) levels ≤ 2.5 times the ULN for patients without liver metastases; and AST and ALT levels ≤ 5 times the ULN for patients with documented liver metastases. 11. good renal function, defined as serum creatinine ≤ 1.5 times ULN or calculated creatinine clearance ≥ 60 ml/min; urine protein less than 2+ on routine urine examination, or 24-hour urine protein quantification < 1 g. 12. Women of childbearing potential should have a negative urine or serum pregnancy test within 3 days prior to receiving the first dose of study drug (Week 1, Day 1). 13. male patients should be using barrier contraception (i.e., condoms) from screening until 6 months after discontinuation of study treatment. 14. Subjects will voluntarily participate and sign an informed consent in writing.

Exclusion Criteria:

1. Received any of the following treatments: 1. Currently participating in an interventional clinical study treatment or received another study drug within 4 weeks prior to the first dose. 2. Received palliative intracranial radiation therapy prior to the first dose. 3. Patient has undergone major surgery (including biopsy) or major trauma within 4 weeks prior to the first dose of study drug; patients who are expected to require major surgery during the study period. 4. Patients previously treated with EGFR-TKI. 2. patients with NSCLC EGFR driver gene negative or known severe allergic reactions (≥ grade 3) to TKIs drugs; 3. patients who are unable to undergo MR examination. 4. brain metastases requiring surgical decompression; 5. the presence of a previous solid organ or hematologic transplant; clinically active diverticulitis, abdominal abscess, gastrointestinal obstruction; the presence of clinically uncontrollable pleural effusion/peritoneal effusion. 6. malignancy other than non-small cell lung cancer within 5 years prior to enrollment, excluding adequately treated carcinoma in situ of the cervix, basal cell or squamous epithelial cell skin cancer of the skin, localized prostate cancer after radical surgery, and ductal carcinoma in situ of the breast; 7. having unremitting residual toxicity of prior therapy greater than CTCAE grade 1 at the time of initiation of study treatment, with the exception of alopecia and grade 2 neurotoxicity from prior chemotherapy; 8. have any serious or poorly controlled systemic disease, such as active bleeding-prone body or active infection, as judged by the investigator. Chronic illnesses that do not require exclusion; 9. the known presence of a psychiatric illness or substance abuse condition that may have an impact on compliance with trial requirements. 10. any serious or uncontrolled ocular pathology that, in the judgment of the physician, may increase the safety risk to the patient. 11. a known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive) 12. patients who, in the judgment of the investigator, are likely to be poorly compliant with the procedures and requirements of the study.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05800223
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Shanghai Cancer Hospital, China
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Non-small Cell Lung Cancer Metastatic
Arms & Interventions

Arms

Experimental: GroupA

Intracranial stereotactic radiotherapy (27-40 Gy/3-5f) was administered to all intracranial lesions on the first day of oral administration of Almonertinib

Experimental: GroupB

Two successive MR enhancements after oral administration of Almonertinib suggest that intracranial lesions are maximally remission, and stereotactic body radiotherapy is given to all lesions (27-40Gy/3-5f)

Experimental: GroupC

oral administration of Almonertinib

Interventions

Drug: - Almonertinib

The dosage is 110 mg/day (2 tablets/day) orally once a day

Radiation: - SBRT

SRT, 27Gy-40Gy/3-5f

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China

Status

Recruiting

Address

Fudan University Shanghai Cancer Center

Shanghai, Shanghai, 200032

Site Contact

Min Fan, MD

[email protected]

8602164175590