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

Non-small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01951469
• Other study ID #: NSCLC brain metastasis 01
• Status: Recruiting
• Phase: Phase 3
• Start date: January 2016
• Est. completion date: December 2022

Study information

• Verified date: February 2022
• Source: Sun Yat-sen University
• Contact: li-kun Chen, MD
• Phone: 13798019964
• Email: chenlk[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: December 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Metastases
• Brain Neoplasms
• Carcinoma, Non-Small-Cell Lung
• EGFR Mutation
• Lung Neoplasms
• Neoplasm Metastasis
• Non-small Cell Lung Cancer

Intervention

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
• Gefitinib mono-therapy
Gefitinib 250mg is Taken Orally everyday

Locations

Country	Name	City	State
China	Sun Yat-sen University of Cancer Center	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Sun Yat-sen University	Wu Jieping Medical Foundation

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	iPFS(intracranial progression free survival	defined as time from randomization to intracranial progressive disease or death.	2 years
Secondary	ORR	proportion of patients with complete or partial response of overall lesions	2 years
Secondary	intracranial objective response rate (iORR)	proportion of patients with complete or partial response of intracranial lesions	2 years
Secondary	PFS(Progression Free Survival)	time from randomization to overall disease progression or death	2 years
Secondary	OS(Overall Survival)	time from randomization to death from any cause	3 years
Secondary	adverse events	adverse events were evaluated according to NCI-CTCAE 4.0.	3 years