Clinical trial NCT01024413: Phase III Trial to Evaluate the Elortinib vs Gefitinib in Advanced NSCLC With EGFR Exon 19 or 21 Mutations
Official title: A Randomized, Controlled Phase III Trial to Evaluate the Efficacy of Elortinib vs Gefitinib in Advanced Non-small-cell Lung Cancer With EGFR Exon 19 or 21 Mutations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Thoracic Neoplasms
Keywords: Thoracic Neoplasms
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Respiratory Tract Diseases
Lung Neoplasms
Erlotinib
Gefitinib
Epidermal growth factor receptor genes
Lead sponsor: Chinese Society of Lung Cancer
Sponsor class: OTHER
Collaborators: name: Guangdong Provincial People's Hospital
First posted: 2009-12-02
Enrollment: 256
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized controlled trial to compare efficacy and safety between erlotinib and gefitinib in advanced NSCLC harboring EGFR exon 19 or 21 mutations.Eligible patients were randomized to receive erlotinib or gefitinib in any line settings.The primary endpoint was progression-free survival (PFS).

Detailed description: Patients with stage IV NSCLC who have EGFR exon 19 or 21 mutations will randomized to received oral erlotinib 150mg or gefitinib 250mg once daily until disease progression or unacceptable toxicity. Method of direct DNA sequencing of tumor tissue is used to analysis EGFR mutation status of exons 18-21. The response will be evaluated by RECIST criteria first month,second month and then repeat every 3 months after the beginning of the treatment weeks.

Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed stage IIIB (wet) or IV NSCLC.
* Patients with positive EGFR exon19 or exon21 mutation as confirmed by direct sequencing histologically.
* Signing the informed consent form.
* The vital organ functions are tolerant to therapy.
* Have recovered to CTCAE2 grade below from toxicity of previous chemotherapy and radiotherapy
* PS 0-2 scores.
* Functional reserve of bone marrow is adequate, e.g. white blood cell count ≥3.0×109/L, planet count ≥90×109/L, and HB≥80×109/L.
* Serum bilirubin is 2 times less than the upper limit of normal (ULN), ALT and AST are 3 times less than ULN; for liver metastases, ALT and AST need to be 5 times less than ULN; creatinine should be 2 times less than ULN.

Exclusion Criteria:

* Informed consent is not provided.
* Women of pregnancy or breastfeeding.
* Have difficulty in swallowing.

Primary outcomes:
measure: progression-free survival
timeFrame: two years
Secondary outcomes:
measure: overall survival
timeFrame: three years
measure: Safety events
timeFrame: two years
measure: Pharmacoeconomic
timeFrame: two years
measure: Response rate
timeFrame: one year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong General Hospital
state: Guangdong
Study officials:
affiliation: Guangdong Provincial People's Hospital
name: Wu Yi Long, MD
role: PRINCIPAL_INVESTIGATOR
References:
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