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

Non-small Cell Lung Cancer Stage IIIA Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01410214
• Other study ID #: C-LCSG-001
• Status: Recruiting
• Phase: Phase 2
• First received: August 1, 2011
• Last updated: December 21, 2011
• Start date: May 2011
• Est. completion date: July 2017

Study information

• Verified date: December 2011
• Source: Chinese Lung Cancer Surgical Group
• Contact: Xuefeng Kan
• Email: 13920870123[@]126.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: July 2017
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-small Cell Lung Cancer Stage IIIA

Intervention

Drug:
• Erlotinib
In the adjuvant treatment phase, erlotinib 150 mg/day taken orally for 2 years or till disease progression or unacceptable toxicity.
• 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.

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing
China	Chinese PLA General Hospital	Beijing	Beijing
China	The Second People's Hospital of Sichuan	Chengdu	Sichuang
China	Sun Yat-Sen University Cancer Center	Guangzhou	Guangdong
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	Harbin Medical University Cancer Hospital	Harbin	Heilongjiang
China	Qingdao University Medical College	Qingdao	Shandong
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai
China	Hebei Medical University Fourth Hospital	Shijiazhuang	Hebei
China	The First Affiurted Hospital of Soochow University	Suzhou	Jiangsu
China	Tianjin Medical University Cancer Institute and Hospital	Tianji	Tianji

Sponsors (12)

Lead Sponsor	Collaborator
Chinese Lung Cancer Surgical Group	Beijing Cancer Hospital, Chinese PLA General Hospital, Fudan University, Harbin Medical University, Hebei Medical University Fourth Hospital, Qingdao University, Sun Yat-sen University, The First Affiurted Hospital of Soochow University, The Second People's Hospital of Sichuan, Tianjin Medical University Cancer Institute and Hospital, Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival	To evaluate Disease-free survival(DFS) of two groups	2 years	No
Secondary	Number of Participants with Adverse Events	To evaluate the safety profile(Number of Participants with Adverse Events) of two group.	2 years	Yes
Secondary	Quality of Life (QOL)	To evaluate the Quality of Life (QOL) of two group.	2 years	Yes
Secondary	overall survival (OS)	To evaluate the overall survival (OS) of two groups	2 years	No