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

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ClinicalTrials.gov Identifier: NCT01410214

Recruitment Status : Unknown

Verified December 2011 by Chinese Lung Cancer Surgical Group.
Recruitment status was: Recruiting

First Posted : August 5, 2011

Last Update Posted : December 23, 2011

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

The First Affiliated 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

Study Description

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.

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

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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	80 participants
Allocation:	Non-Randomized
Intervention Model:	Parallel Assignment
Masking:	None (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
Study Start Date :	May 2011
Estimated Primary Completion Date :	July 2015
Estimated Study Completion Date :	July 2017

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Lung cancer

MedlinePlus related topics: Lung Cancer

Drug Information available for: Cisplatin Vinorelbine Vinorelbine tartrate Erlotinib hydrochloride Erlotinib

U.S. FDA Resources

Arms and Interventions

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 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

Outcome Measures

Primary Outcome Measures :

Disease-free survival [ Time Frame: 2 years ]
To evaluate Disease-free survival(DFS) of two groups

Secondary Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 70 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
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

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): NCT01410214

Contacts

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Contact: Xuefeng Kan		13920870123@126.com

Locations

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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