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Erlotinib 100mg or 150mg in Treating EGFR Mutated NSCLC

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ClinicalTrials.gov Identifier: NCT02140333
Recruitment Status : Unknown
Verified February 2015 by Jianxing He, The First Affiliated Hospital of Guangzhou Medical University.
Recruitment status was:  Recruiting
First Posted : May 16, 2014
Last Update Posted : February 12, 2015
Sponsor:
Information provided by (Responsible Party):
Jianxing He, The First Affiliated Hospital of Guangzhou Medical University

Study Description
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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.

Condition or disease Intervention/treatment Phase
NSCLC EGFR Mutation Drug: Erlotinib Phase 3

Detailed Description:
In China it was confirmed that 150mg Erlotinib was effective in NSCLC patients wtih EGFR mutation, but reducing dose occurring in some patients because of the drug related side-effects. Thus, we sought to investigate that in Chinese patients with EGFR mutation whether low dose (100mg) Erlotinib had similar efficacy but lower toxcities compared with standad dose (150mg) Erlotinib.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 3 Study of Erlotinib 100mg or 150mg in Treating EGFR Mutated Patients With Non-small Cell Lung Cancer
Study Start Date : August 2013
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Erlotinib 100mg
Erlotinib 100mg
 Drug: Erlotinib
100mg vs. 150mg
Other Name: tarceva
Active Comparator: Erlotinib 150mg
Erlotinib 150mg
 Drug: Erlotinib
100mg vs. 150mg
Other Name: tarceva


Outcome Measures
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Primary Outcome Measures :
  1. Progression free survival [ Time Frame: 2 years after the initial dose ]

Secondary Outcome Measures :
  1. The objective response rate [ Time Frame: Patients will be followed for an expected average of 6 months ]

Other Outcome Measures:
  1. Overall survival [ Time Frame: 3 year after the initial dose ]
  2. Adverse events [ Time Frame: 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histological diagnosis of NSCLC with phase IIIB or IV disease;
  2. Sensitive mutation EGFR gene (18, 19 del, 21 L858R gene mutation) (mutation detection methods:ARMS-PCR, sequence method)
  3. Never received anti-tumor therapies for the advanced stage;
  4. Never used EGFR inhibitors;
  5. Measurable disease by RECIST criteria;
  6. Male or female patients >=18 years of age;
  7. ECOG karnofsky performance 0~3, life expectancy is greater than 12 weeks;
  8. Patients must be accessible for treatment and follow-up;

Exclusion Criteria:

  1. Previously used EGFR inhibitors
  2. Mix ingredients in patients with squamous cell carcinoma, small cell lung cancer;
  3. Allergic to erlotinib;
  4. Non-measurable lesions
  5. Pregnant or lactating women;
  6. Patients having other factors that preventing researchers from enrollment them.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02140333


Contacts
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Contact: jianxing He, PhD 86-20-83062821 drjianxing.he@gmail.com
Contact: yalei zhang, Dr. 86-20-83062821 yayazhang2004@163.com

Locations
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China, Guangdong
Guangzhou medical university Recruiting
Guanzhou, Guangdong, China, 510120
Contact: jianxing he, PhD    86-20-83062821    drjianxing.he@gmail.com   
Principal Investigator: jianxing he, PhD         
Sponsors and Collaborators
The First Affiliated Hospital of Guangzhou Medical University
More Information
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Responsible Party: Jianxing He, The First Affiliated Hospital of Guangzhou Medical Univers, The First Affiliated Hospital of Guangzhou Medical University
ClinicalTrials.gov Identifier: NCT02140333    
Other Study ID Numbers: FAHG20130819
GZMC201301
First Posted: May 16, 2014    Key Record Dates
Last Update Posted: February 12, 2015
Last Verified: February 2015
Keywords provided by Jianxing He, The First Affiliated Hospital of Guangzhou Medical University:
erlotinib
EGFR mutation
Additional relevant MeSH terms:
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Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action