Clinical trial NCT01410214: Erlotinib Versus Vinorelbine/Cisplatin as Adjuvant Treatment in Stage IIIA NSCLC Patients With EGFR Mutations
Official title: A Phase II Trial of Erlotinib Versus Combination of Vinorelbine Plus Cisplatin as Adjuvant Treatment in Stage IIIA Non-small-cell Lung Cancer After Complete Resection With Sensitizing EGFR Mutation in Exon 19 or 21 and Wild-type K-ras
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer Stage IIIA
Keywords: NSCLC
EGFR Mutation Positive
complete resection
Erlotinib Versus NVB/Cisplatin as Adjuvant treatment
Lead sponsor: Chinese Lung Cancer Surgical Group
Sponsor class: OTHER
Collaborators: name: Tianjin Medical University Cancer Institute and Hospital
name: Fudan University
name: Zhejiang Cancer Hospital
name: Peking University Cancer Hospital & Institute
name: Sun Yat-sen University
name: Chinese PLA General Hospital
name: Qingdao University
name: The First Affiliated Hospital of Soochow University
name: The Second Affiliated Hospital of Harbin Medical University
name: Hebei Medical University Fourth Hospital
name: The Second People's Hospital of Sichuan
First posted: 2011-08-05
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the effect and safety of erlotinib versus NVB plus cisplatin (NP) as adjuvant treatment in patients with stage IIIA NSCLC after complete resection with EGFR activating mutations and to explore a new treatment strategy for this subset.

Detailed description: The LACE meta-analysis identified four cycles of platinum-based program to improve II\~IIIA stage completely resected NSCLC pts the role of 5-year survival, but its treatment-related life threatening toxicity limits its use. The EGFR tyrosine kinase inhibitor (TKI) may provide a dramatic response in pts with pulmonary adenocarcinoma carrying EGFR activating mutations in the metastatic setting. The aim of this study is to investigate the efficacy and safety of erlotinib versus NVB plus cisplatin (NP) as adjuvant treatment in pts with stage IIIA NSCLC after Complete Resection with EGFR activating mutations and to explore a new treatment strategy for this subset.

Eligibility criteria: Inclusion Criteria:

* Written informed consent provided.
* Males or females aged ≥18 years.
* Chest CT, brain CT or MRI, ECT, abdominal and double-neck B-, or whole body PET-CT examination in 4 weeks before complete resection.
* Pathological diagnosed of non-small cell lung cancer.
* Diagnosed as stage IIIA.
* In 4 weeks after complete resection pts start to accept the adjuvant therapy in this study, previously did not receive any anti-tumor therapy.
* EGFR activating mutation in exon 19 or 21 and KARS
* ECOG performance status 0-1.
* Life expectancy ≥3 months.
* Adequate hematological function:Absolute neutrophil count (ANC) ≥1.5 x 109/L, and Platelet count ≥100 x 109/L, and Hemoglobin ≥9 g/dL (may be transfused to maintain or exceed this level).
* Adequate liver function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN);Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 x ULN.
* Adequate renal function:Serum creatinine ≤ 1.25 x ULN, and creatinine clearance ≥ 60 ml/min.
* Able to comply with the required protocol and follow-up procedures, and able to receive oral medications.
* Patients must be nonpregnant and non-lactating.Patients of childbearing potential must implement an effective method of contraception during the study. All female Patients, except those who are postmenopausal or surgically sterilized, must have a negative pre-study serum or urine pregnancy test. .

Exclusion Criteria:

* Patients with prior exposure to agents directed at the HER axis (e.g. erlotinib, gefitinib, cetuximab, trastuzumab).
* Patients with prior chemotherapy or therapy with systemic anti-tumour therapy.
* Patients with prior radiotherapy.
* History of another malignancy in the last 5 years with the exception of the following:Cured basal cell carcinoma of the skin and cured in situ carcinoma of the uterine cervix are permitted.
* Any evidence confirmed tumor recurrence before adjuvant treatment.
* Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).
* Any evidence of clinically active interstitial lung disease.
* Eye inflammation or eye infection not fully treated or conditions predisposing the subject to this.
* Known human immunodeficiency virus (HIV) infection.
* Known hypersensitivity to Tarceva or NVB or cisplatin.
* Pregnancy or breast-feeding women.
* ECOG performance status ≥ 2.
* Ingredients mixed with small cell lung cancer patients
* Evidence of any other disease, neurological or metabolic dysfunction, physical examination or laboratory finding giving reasonable suspicion of a disease or condition that contraindicated the use of an investigational drug or puts the subject at high risk for treatment-related complications.

Primary outcomes:
measure: Disease-free survival
timeFrame: 2 years
Secondary outcomes:
measure: Number of Participants with Adverse Events
timeFrame: 2 years
measure: Quality of Life (QOL)
timeFrame: 2 years
measure: overall survival (OS)
timeFrame: 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
city: Guangzhou
country: China
facility: Sun Yat-Sen University Cancer Center
state: Guangdong
city: Shijiazhuang
country: China
facility: Hebei Medical University Fourth Hospital
state: Hebei
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
city: Suzhou
country: China
facility: The First Affiurted Hospital of Soochow University
state: Jiangsu
city: Qingdao
country: China
facility: Qingdao University Medical College
state: Shandong
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
city: Chengdu
country: China
facility: The Second People's Hospital of Sichuan
state: Sichuang
city: Tianji
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
state: Tianji
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Tianjin Medical University Cancer Institute and Hospital
name: Changli Wang
role: PRINCIPAL_INVESTIGATOR
References: