A Study to Determine the Efficiency For Brain Metastasis NSCLC Patients Treated With Icotinib Alone or Combined With Radiation Therapy

NCT04058704 | Unknown Phase 3 DMC

• 1 other identifier: BD-IC-IV99
• Study Type: interventional
• Target: 296
• Locations: 1 country
• Sites: 1

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 .

Conditions

Non Small Cell Lung Cancer; Brain Metastases

Keywords

EGFR-TKI; NSCLC; Icotinib; radiotherapy

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  from date of randomization until the date of death, assessed up to 36 months.

Secondary Outcomes (5)

• Progression-free survival of intracranial lesions

  from date of randomization until the date of progression, assessed up to 10 months

• disease control rate of intracranial lesions

  from date of randomization until the date of progression, assessed up to 18 months

• Quality of life measured by FACT-L/LCS 4.0

  from date of randomization until the date of death from any cause, assessed up to 36 months

• Neurocognitive function changes measured by MMSE

  from date of randomization until the date of death from any cause, assessed up to 36 months

• Observing acute and late toxicity assessed by CTCAE v4.0

  from date of randomization until the date of death from any cause, assessed up to 36 months

Study Arms (2)

Early intervention

EXPERIMENTAL

Icotinib is administered orally three times per day. Radiation therapy (SRS/ WBRT/ HA-WBRT/SMART) start in 1 month since take icotinib orally.

Drug: Icotinib; Radiation: SRS/WBRT/HA-WBRT/SMART

Late intervention

EXPERIMENTAL

Icotinib is administered orally three times per day. Until emerge the progression of the disease, then is given radiation therapy (SRS/WBRT/HA-WBRT/SMART)

Drug: Icotinib; Radiation: SRS/WBRT/HA-WBRT/SMART

Interventions

Icotinib DRUG

125mg Tid/375mg per day

Early intervention; Late intervention

SRS/WBRT/HA-WBRT/SMART RADIATION

\>3 with WBRT/HA-WBRT/SMART or 1-3 with SRS

Early intervention; Late intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Betta Pharmaceuticals Co., Ltd.: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Brain Neoplasms

Interventions

icotinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Chen Ming

  Zhejiang Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chen Ming

CONTACT

+86 18758875572; chenming@zjcc.org.cn

Wang Jin

CONTACT

+86 18858165856; wangjin@zjcc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2019
• First Posted: August 15, 2019
• Study Start: July 20, 2018
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: August 15, 2019

Record last verified: 2019-08

Locations

CN (1)