Clinical trial NCT02006043: Evaluate Erlotinib Efficacy and Safety as the 2nd/3rd Treatment in NSCLC With EGFR M(-) and C-met(-)
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2013-12-09
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

Eligibility 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

Primary outcomes:
measure: 6 months PFS rate
timeFrame: at when last patient enrolled 6 months
Secondary outcomes:
measure: overall survival, OS
timeFrame: at when last patient enrolled 18 months
measure: objective response rate, ORR
timeFrame: at when last patient enrolled 18 months
Other outcomes:
measure: the quality of life of patients
timeFrame: at when last patient enrolled 18 months
Locations:
city: Guangzhou
country: China
facility: Sun Yat-Sen University cnacer center
state: Guangdong
city: Nanning
country: China
facility: Guangxi Medical University cancer center
state: Guangxi
Study officials:
affiliation: Sun Yat-sen University
name: Li Zhang
role: PRINCIPAL_INVESTIGATOR
References: