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Gefitinib With or Without Chemotherapy in Brain Metastases From Non-small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01951469
Recruitment Status : Recruiting
First Posted : September 26, 2013
Last Update Posted : March 8, 2022
Sponsor:
Collaborator:
Wu Jieping Medical Foundation
Information provided by (Responsible Party):
Li-kun Chen, Sun Yat-sen University

Study Description
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Brief Summary:
This is a multi-center phase III randomized controlled study to assess the efficacy of Gefitinib alone and Gefitinib combination with Pemetrexed/platinum on patients with brain metastasis from non-small cell lung cancer(NSCLC) harboring EGFR mutation type by intracranial PFS(iPFS),also PFS ,DCR and OS.The side effect is evaluated as well.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Brain Metastases EGFR Mutation Drug: Gefitinib and Pemetrexed/platinum Drug: Gefitinib mono-therapy Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter Phase III Study of Gefitinib Mono-therapy or Gefitinib Combined With Chemotherapy in Patients With Brain Metastases From Non-small Cell Lung Cancer Harboring EGFR Mutation
Actual Study Start Date : January 2016
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Gefitinib and Pemetrexed/platinum
Gefitinib 250mg is Taken Orally on day 1-28,combined Pemetrexed (D1)+cisplatin (D1-3) chemotherapy or Pemetrexed (D1)+nedaplatin (D1) chemotherapy, every 28 days
 Drug: Gefitinib and Pemetrexed/platinum
Gefitinib 250mg is Taken Orally on day 1-28,combined Pemetrexed (D1)+cisplatin (D1-3) or Pemetrexed (D1) + nedaplatin (D1) chemotherapy, every 28 days
Active Comparator: Gefitinib mono-therapy
Gefitinib 250mg is Taken Orally everyday
 Drug: Gefitinib mono-therapy
Gefitinib 250mg is Taken Orally everyday


Outcome Measures
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Primary Outcome Measures :
  1. iPFS(intracranial progression free survival [ Time Frame: 2 years ]
    defined as time from randomization to intracranial progressive disease or death.


Secondary Outcome Measures :
  1. ORR [ Time Frame: 2 years ]
    proportion of patients with complete or partial response of overall lesions

  2. intracranial objective response rate (iORR) [ Time Frame: 2 years ]
    proportion of patients with complete or partial response of intracranial lesions

  3. PFS(Progression Free Survival) [ Time Frame: 2 years ]
    time from randomization to overall disease progression or death

  4. OS(Overall Survival) [ Time Frame: 3 years ]
    time from randomization to death from any cause

  5. adverse events [ Time Frame: 3 years ]
    adverse events were evaluated according to NCI-CTCAE 4.0.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient who was confirmed stage IV NSCLC with EGFR activating mutation and brain metastases by pathologic histology or cytology
  2. Patients who had never received therapy (including chemotherapy,WBRT,EGFR-TKI and EGFR monoclonal antibody) after diagnosed brain metastases
  3. Patients had at least three metastatic lesions in brain, or patients with 1-2 intracranial lesions who were not suitable for brain radiotherapy, or patients with 1-2 intracranial lesions who refused brain radiotherapy, at least one intracranial lesion with the longest diameter of >5 mm
  4. Adult patients (≥ 18 years and ≤75 years). ECOG Performance Status 0 or 1 Life expectancy of at least 12 weeks.,Haemoglobin ³ 10.0 g/dl, Absolute neutrophil count (ANC) ³1.5 x 109/L, platelets ³ 100 x 109/L. Total bilirubin £ 1.5 x upper limit of normal (ULN). ALT and AST < 2.5 x ULN in the absence of liver metastases, or < 5 x ULN in case of liver metastases. Creatinine clearance ³ 60ml/min (calculated according to Cockcroft-gault formula).
  5. Patients should be contraceptive during the period of the trial until 8 weeks after the last administration of icotinib.
  6. Able to comply with the required protocol and follow-up procedures, and able to receive oral medications.

Exclusion Criteria:

  1. Patient was received irradiation of brain. Patient with meningeal metastases were confirmed by MRI or cytology test of cerebrospinal fluid.
  2. Patient is received the treatment of Phenytoin, carbamazepine, rifampicin, phenobarbital, or St. John's Wort.
  3. Patient was received EGFR Tyrosine Kinase Inhibitor or EGFR monoclonal antibody.
  4. Interstitial pneumonia.Pericardial effusion, pleural effusion is uncontrolled .
  5. Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).
  6. Any significant ophthalmologic abnormality ,especially severe dry eye syndrome ,keratoconjunctivitis sicca,Sjogren syndrome,severe exposure keratitis or any other disorder likely to increase the risk of corneal epithelial lesions.
  7. Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication, or have active peptic ulcer disease.
  8. The symptoms of increased intracranial pressure are uncontrolled after dehydration and cortisone treatment
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01951469


Contacts
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Contact: li-kun Chen, MD 13798019964 chenlk@sysucc.org.cn
Contact: Xue Hou 13570569436 houxue@sysucc.org.cn

Locations
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China, Guangdong
Sun Yat-sen University of Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: li-kun Chen, doctor    13798019964    chenlk@sysucc.org.cn   
Principal Investigator: li-kun Chen, doctor         
Sponsors and Collaborators
Sun Yat-sen University
Wu Jieping Medical Foundation
More Information
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Responsible Party: Li-kun Chen, medical doctor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01951469    
Other Study ID Numbers: NSCLC brain metastasis 01
First Posted: September 26, 2013    Key Record Dates
Last Update Posted: March 8, 2022
Last Verified: February 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplasm Metastasis
Brain Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Neoplastic Processes
Pathologic Processes
 Central Nervous System Neoplasms
Nervous System Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pemetrexed
Gefitinib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors
Protein Kinase Inhibitors