Clinical trial NCT04058704: A Study to Determine the Efficiency For Brain Metastasis NSCLC Patients Treated With Icotinib Alone or Combined With Radiation Therapy
Official title: A Multi-center, Prospective Study to Determine the Efficiency of Icotinib Combined With Radiation Therapy Early Intervention or Late Intervention For NSCLC Patients With Brain Metastases and EGFR(Epidermal Growth Factor Receptor) Mutation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Non Small Cell Lung Cancer
Brain Metastases
Keywords: EGFR-TKI
NSCLC
Icotinib
radiotherapy
Lead sponsor: Betta Pharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-08-15
Enrollment: 296
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy of icotinib alone or in combination with radiation therapy for NSCLC patients harboring EGFR mutation with brain metastases. The primary endpoint is overall survival .

Detailed description: Non-small cell lung cancer (NSCLC) is one of the malignant tumors with the highest incidence of brain metastases, and most patients died due to the progression of brain metastases. Some research show that icotinib combined with radiation therapy can improve the efficiency of NSCLC with brain metastases, but there is still controversial about the timing of radiation therapy intervention . This study is a prospective, multi-center, randomized, controlled trial of icotinib combined with early intervention or late intervention radiation therapy for NSCLC patients harboring EGFR mutation with brain metastases. They will be treated with icotinib and divided into 2 groups. Group 1: the radiation therapy will start within 1 month after icotinib treatment; Group2: the patients will be treated with icotinib first, radiation therapy intervene if disease progress.

Eligibility criteria: Inclusion Criteria:

* Histological or cytological confirmation of non-small-cell lung cancer (NSCLC)
* Positive EGFR mutation（Ex19del or 21L858R）
* Primary diagnosis of brain metastases
* Have one or more measurable encephalic lesions according to RECIST
* Extracranial transfer organ≤3
* ECGO:0-2
* Adequate hematological function: Absolute neutrophil count (ANC) ≥1.5 x 109/L, and Platelet count ≥100 x 109/L.
* Adequate renal function: Serum creatinine ≤1.5 x ULN, or ≥ 50 ml/min.
* Adequate liver function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN) and -Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) \< 2.5 x ULN in the absence of liver metastases, or \< 5 x ULN in case of liver metastases.
* Female subjects should not be pregnant.
* All human subjects should able to comply with the required protocol and follow-up procedures, and able to receive oral medications.
* Written informed consent provided.

Exclusion Criteria:

* Previous usage of EGFR-TKI : gefitinib, erlotinib, icotinib，or any other TKI
* CSF or MRI findings consistent with metastases of spinal cord, meninges or meningeal.
* Allergic to Icotinib.
* Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication, or have active peptic ulcer disease.
* Pregnancy or breast-feeding women.
* Participate in the other anti-tumor clinical trials in 4 weeks. have quit from the trail before.
* Any other serious underlying medical, psychological and other condition that, in the judgment of the investigator, may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications.

Primary outcomes:
measure: Overall Survival
timeFrame: from date of randomization until the date of death, assessed up to 36 months.
Secondary outcomes:
measure: Progression-free survival of intracranial lesions
timeFrame: from date of randomization until the date of progression, assessed up to 10 months
measure: disease control rate of intracranial lesions
timeFrame: from date of randomization until the date of progression, assessed up to 18 months
measure: Quality of life measured by FACT-L/LCS 4.0
timeFrame: from date of randomization until the date of death from any cause, assessed up to 36 months
measure: Neurocognitive function changes measured by MMSE
timeFrame: from date of randomization until the date of death from any cause, assessed up to 36 months
measure: Observing acute and late toxicity assessed by CTCAE v4.0
timeFrame: from date of randomization until the date of death from any cause, assessed up to 36 months
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Zhejiang Cancer Hospital
name: Chen Ming
role: PRINCIPAL_INVESTIGATOR
References: