Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

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Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Respiratory Tract Diseases

Thoracic Neoplasms

All Drugs and Chemicals

Antineoplastic Agents

Amino Acids

Mitogens

Erlotinib Hydrochloride

Gefitinib

Protein Kinase Inhibitors

Tyrosine Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

erlotinib 150 mg oral till disease progression

gefitinib 250mg oral till disease progression.

study arm.erlotinib 150 mg oral till disease progression

erlotinib

study arm.gefitinib 250 mg oral till disease progression

gefitinib

Wu Yi Long, MD

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).

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.

Phase III Trial to Evaluate the Elortinib vs Gefitinib in Advanced NSCLC With EGFR Exon 19 or 21 Mutations

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

Guangdong Provincial People's Hospital

Chinese Society of Lung Cancer

Professor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Phase III Trial to Evaluate the Elortinib vs Gefitinib in Advanced NSCLC With EGFR Exon 19 or 21 Mutations	NCT01024413	Thoracic Neopla...	erlotinib gefitinib	-	Chinese Society of Lung Cancer
Phase III Trial to Evaluate the Elortinib vs Gefitinib in Advanced NSCLC With EGFR Exon 19 or 21 Mutations	NCT01024413	Thoracic Neopla...	erlotinib gefitinib	-	Chinese Society of Lung Cancer

Spots Global Cancer Trial Database for epidermal growth factor receptor genes