- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02006043
Evaluate Erlotinib Efficacy and Safety as the 2nd/3rd Treatment in NSCLC With EGFR M(-) and C-met(-)
July 1, 2015 updated by: Li Zhang
A Phase II, Open, Single Arm Trial to Evaluate Erlotinib Efficacy and Safety as the 2nd/3rd Line Treatment in Advanced or Recurrent NSCLC With EGFR Wild Type and Without C-met Expression
evaluate Erlotinib efficacy and safety as the 2nd/3rd line treatment in advanced or recurrent NSCLC with EGFR wild type and without c-met expression
Study Overview
Detailed Description
In this phase II, open, single arm study, it will be evaluated of the efficacy and safety of erlotinib in 2nd/3rd line of EGFR WT and c-Met negative advanced NSCLC.The treatment goes as follows:Erlotinib 150mg/day taken orally until disease progression or intolerable toxicities.The primary end point of the study was 6 months PFS rate.
Study Type
Interventional
Enrollment (Anticipated)
54
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ting Zhou
- Phone Number: 86-020-87343689
- Email: zhouting@sysucc.org.cn
Study Contact Backup
- Name: Yan Huang
- Phone Number: 86-020-87343689
- Email: huangyan@sysucc.org.cn
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510030
- Recruiting
- Sun Yat-Sen University cnacer center
-
Contact:
- Ting Zhou
- Phone Number: 86-020-87343689
- Email: zhouting@sysucc.org.cn
-
Sub-Investigator:
- Yan Huang
-
-
Guangxi
-
Nanning, Guangxi, China, 530021
- Recruiting
- Guangxi Medical University Cancer Center
-
Contact:
- Hua Huaqing
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Histologically or cytological documented metastatic (stage IV) or recurrent NSCLC
- Measurable disease must be characterized according to the response evaluation criteria in solid tumors(RECIST1.1) criteria
- Must have at least one prior platinum-based chemotherapy regimen for advanced NSCLC and now exhibit progressive disease (PD), and must have recovered from any serious treatment related toxicity
- Neither with EGFR mutation nor c-met expression on Ventana Benchmark instrument(Met negative expression definition: ≥50% of the cells do not stain or stain with weak intensity (clinical score 0 or 1+) )
- ECOG Performance Status 0 ~2
- Adequate hematological function: Neutrophil count ≥ 1.5 × 109/L, Platelets ≥ 100 × 109/L and Hemoglobin ≥9 g/dL (may be transfused to maintain or exceed this level).
- Adequate liver function: Total bilirubin ≤ 1.5 × upper limit of normal (ULN); AST (SGOT) and ALT (SGPT) < 2.5 × ULN in the absence of liver metastases, or < 5 × ULN in case of liver metastases.
- Male or female.
- Age ≥ 18 years and ≤75 years
- Written (signed) informed consent. Able to comply with study and follow-up procedures.
Exclusion Criteria:
- Patients with prior exposure to agents directed at the HER axis (e.g. erlotinib, gefitinib, cetuximab, trastuzumab).
Received treatment with any other investigational agent, or participated in another clinical trial, with the following exceptions.
- Chemotherapy-only trials are permitted (if completed≧ 28 days prior to receiving the first dose of study drug).
- Previous adjuvant or neo-adjuvant treatment for nonmetastatic disease is permitted if completed ≥ 6 months before receiving the first dose of study drug; c)Prior surgery is permitted if performed ≥ 4 weeks before receiving the first dose of study drug and the patient is fully recovered.
- Prior localized radiotherapy is permitted if it was not administered to target lesions selected for this study, unless progression of the selected target lesions within the radiation portal is documented, and provided it has been completed ≥ 4 weeks before receiving the first dose of study drug.
- Participation in a methodological or observational study in which no investigational agent was given
- Patients who have brain metastasis or spinal cord compression that has not yet been definitively treated with surgery and/or radiation; previously diagnosed and treated CNS metastases or spinal cord compression without evidence of stable disease (clinically stable imaging) for at least 2 months
History of another malignancy in the last 5 years with the exception of the following:
- Other malignancies cured by surgery alone and having a continuous disease-free interval of 5 years are permitted.
- Cured basal cell carcinoma of the skin and cured in situ carcinoma of the uterine cervix are permitted.
- Any significant ophthalmologic abnormality, especially severe dry eye syndrome, keratoconjunctivitis sicca, Sjögren syndrome, severe exposure keratitis or any other disorder likely to increase the risk of corneal epithelial lesions. The use of contact lenses is not recommended during the study. The decision to continue to wear contact lenses should be discussed with the patient's treating oncologist and the ophthalmologist.
- Any diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of any study medication or that might affect the interpretation of the results or render the subject at high risk from treatment complications.
- Female subject who is pregnant or breast-feeding
- Any unstable systemic disease
- Hypersensitivity to erlotinib
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Erlotinib 150mg/day taken orally
Erlotinib 150mg/day taken orally until disease progression or intolerable toxicities
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
6 months PFS rate
Time Frame: at when last patient enrolled 6 months
|
at when last patient enrolled 6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
overall survival, OS
Time Frame: at when last patient enrolled 18 months
|
at when last patient enrolled 18 months
|
objective response rate, ORR
Time Frame: at when last patient enrolled 18 months
|
at when last patient enrolled 18 months
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
the quality of life of patients
Time Frame: at when last patient enrolled 18 months
|
at when last patient enrolled 18 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2013
Primary Completion (Anticipated)
December 1, 2016
Study Registration Dates
First Submitted
November 26, 2013
First Submitted That Met QC Criteria
December 6, 2013
First Posted (Estimate)
December 9, 2013
Study Record Updates
Last Update Posted (Estimate)
July 3, 2015
Last Update Submitted That Met QC Criteria
July 1, 2015
Last Verified
July 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Erlotinib Hydrochloride
Other Study ID Numbers
- ML28941
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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