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Evaluate Erlotinib Efficacy and Safety as the 2nd/3rd Treatment in NSCLC With EGFR M(-) and C-met(-)

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ClinicalTrials.gov Identifier: NCT02006043
Recruitment Status : Unknown
Verified July 2015 by Li Zhang, Sun Yat-sen University.
Recruitment status was:  Recruiting
First Posted : December 9, 2013
Last Update Posted : July 3, 2015
Sponsor:
Information provided by (Responsible Party):
Li Zhang, Sun Yat-sen University

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: Erlotinib 150mg Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : December 2013
Estimated Primary Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Erlotinib 150mg/day taken orally
Erlotinib 150mg/day taken orally until disease progression or intolerable toxicities
Drug: Erlotinib 150mg



Primary Outcome Measures :
  1. 6 months PFS rate [ Time Frame: at when last patient enrolled 6 months ]

Secondary Outcome Measures :
  1. overall survival, OS [ Time Frame: at when last patient enrolled 18 months ]
  2. objective response rate, ORR [ Time Frame: at when last patient enrolled 18 months ]

Other Outcome Measures:
  1. the quality of life of patients [ Time Frame: at when last patient enrolled 18 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Histologically or cytological documented metastatic (stage IV) or recurrent NSCLC
  2. Measurable disease must be characterized according to the response evaluation criteria in solid tumors(RECIST1.1) criteria
  3. 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
  4. 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+) )
  5. ECOG Performance Status 0 ~2
  6. 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).
  7. 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.
  8. Male or female.
  9. Age ≥ 18 years and ≤75 years
  10. Written (signed) informed consent. Able to comply with study and follow-up procedures.

Exclusion Criteria:

  1. Patients with prior exposure to agents directed at the HER axis (e.g. erlotinib, gefitinib, cetuximab, trastuzumab).
  2. 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
  3. 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
  4. 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.
  5. 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.
  6. 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.
  7. Female subject who is pregnant or breast-feeding
  8. Any unstable systemic disease
  9. Hypersensitivity to erlotinib

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): NCT02006043


Contacts
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Contact: Ting Zhou 86-020-87343689 zhouting@sysucc.org.cn
Contact: Yan Huang 86-020-87343689 huangyan@sysucc.org.cn

Locations
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China, Guangdong
Sun Yat-Sen University cnacer center Recruiting
Guangzhou, Guangdong, China, 510030
Contact: Ting Zhou    86-020-87343689    zhouting@sysucc.org.cn   
Sub-Investigator: Yan Huang         
China, Guangxi
Guangxi Medical University cancer center Recruiting
Nanning, Guangxi, China, 530021
Contact: Hua Huaqing         
Sponsors and Collaborators
Li Zhang
Investigators
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Principal Investigator: Li Zhang Sun Yat-sen University

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Responsible Party: Li Zhang, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02006043     History of Changes
Other Study ID Numbers: ML28941
First Posted: December 9, 2013    Key Record Dates
Last Update Posted: July 3, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action