Erlotinib 100mg or 150mg in Treating EGFR Mutated NSCLC
Phase 3 Study of Erlotinib 100mg or 150mg in Treating EGFR Mutated Patients With Non-small Cell Lung Cancer
2 other identifiers
interventional
220
1 country
1
Brief Summary
The purpose of this study is to determine whether 100mg erlotinib had similar effect compared with 150mg erlotinib in NSCLC patients with EGFR mutation in China.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Aug 2013
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2013
CompletedFirst Submitted
Initial submission to the registry
October 5, 2013
CompletedFirst Posted
Study publicly available on registry
May 16, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedFebruary 12, 2015
February 1, 2015
5 years
October 5, 2013
February 11, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression free survival
2 years after the initial dose
Secondary Outcomes (1)
The objective response rate
Patients will be followed for an expected average of 6 months
Other Outcomes (2)
Overall survival
3 year after the initial dose
Adverse events
1 year
Study Arms (2)
Erlotinib 100mg
EXPERIMENTALErlotinib 100mg
Erlotinib 150mg
ACTIVE COMPARATORErlotinib 150mg
Interventions
Eligibility Criteria
You may qualify if:
- Histological diagnosis of NSCLC with phase IIIB or IV disease;
- Sensitive mutation EGFR gene (18, 19 del, 21 L858R gene mutation) (mutation detection methods:ARMS-PCR, sequence method)
- Never received anti-tumor therapies for the advanced stage;
- Never used EGFR inhibitors;
- Measurable disease by RECIST criteria;
- Male or female patients \>=18 years of age;
- ECOG karnofsky performance 0\~3, life expectancy is greater than 12 weeks;
- Patients must be accessible for treatment and follow-up;
You may not qualify if:
- Previously used EGFR inhibitors
- Mix ingredients in patients with squamous cell carcinoma, small cell lung cancer;
- Allergic to erlotinib;
- Non-measurable lesions
- Pregnant or lactating women;
- Patients having other factors that preventing researchers from enrollment them.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Guangzhou medical university
Guanzhou, Guangdong, 510120, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- The First Affiliated Hospital of Guangzhou Medical Univers
Study Record Dates
First Submitted
October 5, 2013
First Posted
May 16, 2014
Study Start
August 1, 2013
Primary Completion
August 1, 2018
Study Completion
December 1, 2018
Last Updated
February 12, 2015
Record last verified: 2015-02