Third-line Treatment of Gefitinib in NSCLC Patients

G

Guangdong Association of Clinical Trials

Status and phase

Completed
Phase 2

Conditions

Non Small Cell Lung Cancer

Treatments

Drug: Gefitinib

Study type

Interventional

Funder types

Other

Identifiers

NCT01933347
CTONG1304

Details and patient eligibility

About

The purpose of this study is to evaluate the disease control rate (DCR) of gefitinib as third-line retreatment in stage IIIB/IV NSCLC with EGFR 19del/L858R positive mutation patients who had benefited from first-line gefitinib treatment with EGFR 19del/L858R positive mutation and tumor progression after the second-line chemotherapy

Full description

Primary Study Objective: To evaluate the disease control rate (DCR) of gefitinib as third-line retreatment in stage IIIB/IV NSCLC with EGFR 19del/L858R positive mutation patients who had benefited from first-line gefitinib treatment with EGFR 19del/L858R positive mutation and tumor progression after the second-line chemotherapy Secondary Study Objectives: To evaluate objective response rate (ORR), progressive-free survival (PFS), overall survival(OS) and quality of life (QoL) of gefitinib as third-line retreatment in NSCLC patients To evaluate the safety of gefitinib as third-line treatment in NSCLC patients Exploratory analyses: To dynamically monitor EGFR mutation status and explore the relationship with clinical outcome

Enrollment

46 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • The subject or legal guardian could understand and sign informed consent form.
  • Male or female aged 18 years or older;
  • Subjects were diagnosed with stage IIIB or IV NSCLC before starting the first dose of gefitinib third-line treatment;
  • EGFR exon 19 deletion or exon 21 L858R substitution mutation confirmed;
  • ECOG performance status 0-2;
  • Life expectancy of at least 12 weeks or longer;
  • Has at least one measureable lesion by RECIST 1.1;
  • NSCLC of enrolled subjects previously progressed after first-line gefitinib treatment (PFS ≥ 6 months) and progressed again after second-line chemotherapy (not limited for chemotherapy regimen, ≥ 4 cycles of chemotherapy). Investigator considers adopting third-line gefitinib retreatment;

Criteria for laboratory examinations:

  • Total bilirubin (TB) ≤ 1.5 times upper limit of normal
  • Aspartate aminotransferase(AST), alanine aminotransferase (ALT) ≤2 times upper limit of normal; for subjects with hepatic metastasis, AST,ALT≤ 5 times upper limit of normal
  • Creatinine clearance≥45ml/min

Exclusion criteria

  • Known severe hypersensitivity to gefitinib or any ingredients of the product;
  • Patients with prior exposure to agents directed at the EGFR axis except gefitinib (e.g. erlotinib, cetuximab, trastuzumab) ;
  • Pre-existing interstitial lung disease or pulmonary fibrosis evidenced by CT scan at baseline;
  • Neutrophil count <1.0×109/L or platelet count <50×109/L;
  • Severe infection, uncontrolled systemic disease (e.g cardiopulmonary insufficiency, fatal arrhythmias, hepatitis, etc);
  • Pregnancy or breast-feeding;
  • Women of childbearing age refuse to take adequate contraception measures during gefitinib treatment
  • Subjects with other malignant tumors combined;
  • Known or suspected brain metastases or spinal cord compression, unless treated with surgery and/or radiation and stable without steroid treatment for at least 4 weeks prior to the first dose of study medication;
  • Subjects are unable to take medications orally or have digestive malabsorption;
  • Investigators consider subjects should not be involved in the study.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

46 participants in 1 patient group

Gefitinib 250mg/d
Experimental group
Description:
Subjects will receive the oral administration of gefitinib 250mg/d until the tumor progression, perform scheduled visits in investigational sites at interview day and complete related examinations during follow-up period.
Treatment:
Drug: Gefitinib

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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