Erlotinib Versus Vinorelbine/Cisplatin as Adjuvant Treatment in Stage IIIA NSCLC Patients With EGFR Mutations

This study is currently recruiting participants.
Verified December 2011 by Chinese Lung Cancer Surgical Group
Sponsor:
Collaborators:
Tianjin Medical University Cancer Institute and Hospital
Fudan University
Zhejiang Cancer Hospital
Beijing Cancer Hospital
Sun Yat-sen University
Chinese PLA General Hospital
Qingdao University Medical College
The First Affiurted Hospital of Soochow University
Harbin Medical University
Hebei Medical University Fourth Hospital
The Second People's Hospital of Sichuan
Information provided by (Responsible Party):
Chinese Lung Cancer Surgical Group
ClinicalTrials.gov Identifier:
NCT01410214
First received: August 1, 2011
Last updated: December 21, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention Phase
Non-small Cell Lung Cancer Stage IIIA
Drug: Erlotinib
Drug: vinorelbine/cisplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Chinese Lung Cancer Surgical Group:

Primary Outcome Measures:
  • Disease-free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To evaluate Disease-free survival(DFS) of two groups


Secondary Outcome Measures:
  • Number of Participants with Adverse Events [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    To evaluate the safety profile(Number of Participants with Adverse Events) of two group.

  • Quality of Life (QOL) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    To evaluate the Quality of Life (QOL) of two group.

  • overall survival (OS) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To evaluate the overall survival (OS) of two groups


Estimated Enrollment: 80
Study Start Date: May 2011
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Erlotinib arm
In the adjuvant treatment phase, erlotinib 150 mg/day taken orally for 2 years or till disease progression or unacceptable toxicity.
Drug: Erlotinib
In the adjuvant treatment phase, erlotinib 150 mg/day taken orally for 2 years or till disease progression or unacceptable toxicity.
Other Name: tarceva
Active Comparator: Chemo arm
In the adjuvant treatment phase, patient will receive vinorelbine 25mg/m2 IV on day 1 and day 8, and cisplatin 25mg/m2 on day 1 and day 2 and day 3, of a 3-week schedule for 4 cycles or till disease progression or unacceptable toxicity.
Drug: vinorelbine/cisplatin
In the adjuvant treatment phase, patient will receive vinorelbine 25mg/m2 IV on day 1 and day 8, and cisplatin 25mg/m2 on day 1 and day 2 and day 3, of a 3-week schedule for 4 cycles or till disease progression or unacceptable toxicity.
Other Names:
  • NP
  • NVB/cisplatin

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01410214

Contacts
Contact: Xuefeng Kan 13920870123@126.com

Locations
China, Beijing
Beijing Cancer Hospital Recruiting
Beijing, Beijing, China, 100000
Contact: Chao Lv         
Principal Investigator: Yue Yang         
Chinese PLA General Hospital Not yet recruiting
Beijing, Beijing, China, 100000
Contact: Tao Wang         
Principal Investigator: Xiangyang Chu         
China, Guangdong
Sun Yat-Sen University Cancer Center Not yet recruiting
Guangzhou, Guangdong, China, 510000
Contact: Lanjun Zhang         
Principal Investigator: Lanjun Zhang         
China, Hebei
Hebei Medical University Fourth Hospital Recruiting
Shijiazhuang, Hebei, China, 050000
Contact: Xinbo Liu         
Principal Investigator: Junfeng Liu         
China, Heilongjiang
Harbin Medical University Cancer Hospital Recruiting
Harbin, Heilongjiang, China, 150000
Contact: Changfa Qu         
Principal Investigator: Shidong Xu         
China, Jiangsu
The First Affiurted Hospital of Soochow University Not yet recruiting
Suzhou, Jiangsu, China, 215000
Contact: Haitao Ma         
Principal Investigator: Haitao Ma         
China, Shandong
Qingdao University Medical College Not yet recruiting
Qingdao, Shandong, China, 266000
Contact: Yongjie Wang         
Principal Investigator: Yi Shen         
China, Shanghai
Fudan University Shanghai Cancer Center Not yet recruiting
Shanghai, Shanghai, China, 200000
Contact: Yihua Sun         
Principal Investigator: Haiquan Chen         
China, Sichuang
The Second People's Hospital of Sichuan Recruiting
Chengdu, Sichuang, China, 610000
Contact: Qiang Li         
Principal Investigator: Qiang Li         
China, Tianji
Tianjin Medical University Cancer Institute and Hospital Recruiting
Tianji, Tianji, China, 300000
Contact: Xuefeng Kan         
Principal Investigator: Changli Wang         
China, Zhejiang
Zhejiang Cancer Hospital Not yet recruiting
Hangzhou, Zhejiang, China, 310000
Contact: Xinming Zhou         
Principal Investigator: Weimin Mao         
Sponsors and Collaborators
Chinese Lung Cancer Surgical Group
Tianjin Medical University Cancer Institute and Hospital
Fudan University
Zhejiang Cancer Hospital
Beijing Cancer Hospital
Sun Yat-sen University
Chinese PLA General Hospital
Qingdao University Medical College
The First Affiurted Hospital of Soochow University
Harbin Medical University
Hebei Medical University Fourth Hospital
The Second People's Hospital of Sichuan
Investigators
Principal Investigator: Changli Wang Tianjin Medical University Cancer Institute and Hospital
  More Information

No publications provided

Responsible Party: Chinese Lung Cancer Surgical Group
ClinicalTrials.gov Identifier: NCT01410214     History of Changes
Other Study ID Numbers: C-LCSG-001
Study First Received: August 1, 2011
Last Updated: December 21, 2011
Health Authority: China: Ethics Committee

Keywords provided by Chinese Lung Cancer Surgical Group:
NSCLC
EGFR Mutation Positive
complete resection
Erlotinib Versus NVB/Cisplatin as Adjuvant treatment

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Vinorelbine
Cisplatin
Vinblastine
Erlotinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 17, 2014