Status:
UNKNOWN
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
Lead Sponsor:
Shanghai Cancer Hospital, China
Conditions:
Lung Cancer Stage IV
Eligibility:
All Genders
15-75 years
Phase:
PHASE2
Brief Summary
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 intracran...
Eligibility Criteria
Inclusion
- Age ≥ 18 and ≤ 75.
- Life expectancy exceeding 3 months.
- Histologic or cytologic pathology confirmed non-small cell lung cancer. However, sputum cytology results alone are not acceptable. The cytology results of tracheal swabbing, tracheal irrigation fluid and needle aspiration are acceptable.
- Investigators have confirmed the presence of at least one intracranial measurable lesion according to RECIST 1.1 criteria.
- Patients with stage IV NSCLC with intracranial metastases at MR baseline.
- Eastern Oncology Collaborative Group (ECOG) fitness status score of 0 or 1.
- Genetic testing suggests EGFR driver gene positivity, which can be accompanied by other driver gene positivity.
- Oligo-progression of intracranial tumors at the most recent evaluation following treatment with third- generation TKIs.
- Good hematopoiesis, defined as an absolute neutrophil count ≥1.5 × 109/L, platelet count ≥100 ×109/L, blood erythropoietin ≥ 90 g/L \[7 days without transfusion or erythropoietin (EPO-dependent).
- Good liver function, defined as total bilirubin levels ≤ 1.5 times the upper limit of normal (ULN); inpatients without hepatic metastases, glutinous rice straw is used as a supplement.
- Aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤ 2.5 times ULN; for patients with documented liver metastases. AST and ALT levels ≤5 times ULN.
- Good renal function, defined as serum creatinine ≤ 1.5 times ULN or calculated creatinine clearance ≥60 ml/min
- (Cockcroft-Gault formula); less than 2+ urine protein on routine urinalysis, or 24-hour urine protein quantification \<1 g.
- Good coagulation, defined as an International Standardized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5times ULN; if the subject is receiving anticoagulant therapy, provided that the PT is within the intended range of use of the anticoagulant.
- For female subjects of childbearing age, within 3 days prior to receiving the first study drug administration (Week 1, Day 1) A negative urine or serum pregnancy test is performed. If a negative urine pregnancy test cannot be confirmed, a blood pregnancy test may be ordered test.
- High-performance contraception (i.e., methods with a failure rate of less than 1 per cent per year) for both male and female patients if there is a risk of conception.
Exclusion
- NSCLC EGFR driver gene negativity.
- Patients who cannot be examined by MR.
- Pathological examination of a mixture of small cell lung cancer components.
- Currently participating in an interventional clinical research treatment or have received another investigational drug within 4 weeks prior to the first administration of the drug.
- Use of third-generation TKIs or major surgical procedures within 3 weeks prior to the first dose of the drug.
- Received palliative intracranial radiotherapy prior to first administration.
- Presence of clinically active diverticulitis, abdominal abscesses, gastrointestinal obstruction.
- Have received a transplant of a solid organ or blood system.
- Presence of clinically uncontrollable pleural effusion/abdominal fluid.
- Known severe allergic reaction (≥ grade 3) to TKIs.
- Have not sufficiently recovered from toxicity and/or complications from any of the interventions prior to initiating treatment (i.e. ≤ grade 1 or at baseline, not including weakness or hair loss).
- Diagnosis of other malignancies within 5 years prior to the first dose, with exceptions including radically treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or radically resected carcinoma in situ.
- Active infections that require systemic treatment.
- The known existence of a mental illness or substance abuse condition that may affect compliance with the test requirements.
- Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive).
- Evidence of a medical history or illness that could interfere with the results of the trial, prevent the subject from participating throughout the study, abnormal values for treatment or laboratory tests, or other circumstances that, in the opinion of the investigator, make enrollment unsuitable.
- Breastfeeding women.
Key Trial Info
Start Date :
January 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 15 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04519983
Start Date
January 1 2022
End Date
December 15 2023
Last Update
March 20 2023
Active Locations (1)
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1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032