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

Primary Purpose

Thoracic Neoplasms

Status

Completed

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

erlotinib

gefitinib

About this trial

This is an interventional treatment trial for Thoracic Neoplasms focused on measuring Thoracic Neoplasms, Molecular Mechanisms of Pharmacological Action, Protein Kinase Inhibitors, Respiratory Tract Diseases, Lung Neoplasms, Erlotinib, Gefitinib, Epidermal growth factor receptor genes

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Guangdong General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

erlotinib

gefitinib

Arm Description

erlotinib 150 mg oral till disease progression

gefitinib 250mg oral till disease progression.

Outcomes

Primary Outcome Measures

progression-free survival

Secondary Outcome Measures

overall survival

Safety events

Pharmacoeconomic

Response rate

Full Information

NCT ID

NCT01024413

First Posted

December 1, 2009

Last Updated

February 28, 2017

Sponsor

Chinese Society of Lung Cancer

Collaborators

Guangdong Provincial People's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01024413

Brief Title

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

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

July 2009 (undefined)

Primary Completion Date

June 2015 (Actual)

Study Completion Date

June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chinese Society of Lung Cancer

Collaborators

Guangdong Provincial People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

256 (Actual)

8. Arms, Groups, and Interventions

Arm Title

erlotinib

Arm Type

Experimental

Arm Description

erlotinib 150 mg oral till disease progression

Arm Title

gefitinib

Arm Type

Active Comparator

Arm Description

gefitinib 250mg oral till disease progression.

Intervention Type

Drug

Intervention Name(s)

erlotinib

Other Intervention Name(s)

Tarceva

Intervention Description

study arm.erlotinib 150 mg oral till disease progression

Intervention Type

Drug

Intervention Name(s)

gefitinib

Other Intervention Name(s)

Iressa

Intervention Description

study arm.gefitinib 250 mg oral till disease progression

Primary Outcome Measure Information:

Title

progression-free survival

Time Frame

two years

Secondary Outcome Measure Information:

Title

overall survival

Time Frame

three years

Title

Safety events

Time Frame

two years

Title

Pharmacoeconomic

Time Frame

two years

Title

Response rate

Time Frame

one year

10. Eligibility

Sex

All

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wu Yi Long, MD

Organizational Affiliation

Guangdong Provincial People's Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Guangdong General Hospital

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510080

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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