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

NCT ID: NCT01024413

Last Updated: 2017-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 256 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2015-06-30

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.

Conditions

Thoracic Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

erlotinib

erlotinib 150 mg oral till disease progression

Group Type: EXPERIMENTAL

erlotinib

Intervention Type: DRUG

study arm.erlotinib 150 mg oral till disease progression

gefitinib

gefitinib 250mg oral till disease progression.

Group Type: ACTIVE_COMPARATOR

gefitinib

Intervention Type: DRUG

study arm.gefitinib 250 mg oral till disease progression

Interventions

erlotinib

study arm.erlotinib 150 mg oral till disease progression

Intervention Type: DRUG

gefitinib

study arm.gefitinib 250 mg oral till disease progression

Intervention Type: DRUG

Other Intervention Names

Tarceva; Iressa

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangdong Provincial People's Hospital

OTHER

Sponsor Role: collaborator

Chinese Society of Lung Cancer

OTHER

Sponsor Role: lead

Responsible Party

Yi-Long Wu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wu Yi Long, MD

Role: PRINCIPAL_INVESTIGATOR

Guangdong Provincial People's Hospital

Locations

Guangdong General Hospital

Guangzhou, Guangdong, China

Countries

China

References

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Other Identifiers

C-TONG0901

Identifier Type: -

Identifier Source: org_study_id