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

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

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.

Study Overview

• Status: Unknown
• Conditions: Non-small Cell Lung Cancer Stage IIIA
• Intervention / Treatment: Drug: Erlotinib; Drug: vinorelbine/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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease-free survival	To evaluate Disease-free survival(DFS) of two groups	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Adverse Events	To evaluate the safety profile(Number of Participants with Adverse Events) of two group.	2 years
Quality of Life (QOL)	To evaluate the Quality of Life (QOL) of two group.	2 years
overall survival (OS)	To evaluate the overall survival (OS) of two groups	2 years

Collaborators and Investigators

• Sponsor: Chinese Lung Cancer Surgical Group
• Collaborators: Zhejiang Cancer Hospital; Sun Yat-sen University; Fudan University; Chinese PLA General Hospital; Peking University Cancer Hospital & Institute; Qingdao University; Tianjin Medical University Cancer Institute and Hospital; The First Affiliated Hospital of Soochow University; Hebei Medical University Fourth Hospital; Harbin Medical University; The Second People's Hospital of Sichuan

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Anticipated): July 1, 2015
• Study Completion (Anticipated): July 1, 2017

Study Registration Dates

• First Submitted: August 1, 2011
• First Submitted That Met QC Criteria: August 4, 2011
• First Posted (Estimate): August 5, 2011

Study Record Updates

• Last Update Posted (Estimate): December 23, 2011
• Last Update Submitted That Met QC Criteria: December 21, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: NSCLC; complete resection; EGFR Mutation Positive; Erlotinib Versus NVB/Cisplatin as Adjuvant treatment
• 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; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Protein Kinase Inhibitors; Erlotinib Hydrochloride; Cisplatin; Vinorelbine
• Other Study ID Numbers: C-LCSG-001