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

NCT01410214 | Unknown Phase 2

• 1 other identifier: C-LCSG-001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 11

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.

Conditions

Non-small Cell Lung Cancer Stage IIIA

Keywords

NSCLC; EGFR Mutation Positive; complete resection; Erlotinib Versus NVB/Cisplatin as Adjuvant treatment

Outcome Measures

Primary Outcomes (1)

• Disease-free survival

  To evaluate Disease-free survival(DFS) of two groups

  2 years

Secondary Outcomes (3)

• Number of Participants with Adverse Events

  2 years

• Quality of Life (QOL)

  2 years

• overall survival (OS)

  2 years

Study Arms (2)

Erlotinib arm

EXPERIMENTAL

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

Drug: Erlotinib

Chemo arm

ACTIVE COMPARATOR

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

Interventions

Erlotinib DRUG

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

Also known as: tarceva

Erlotinib arm

vinorelbine/cisplatin DRUG

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.

Also known as: NP, NVB/cisplatin

Chemo arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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. .

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (11)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100000, China

RECRUITING

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100000, China

NOT YET RECRUITING

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, 510000, China

NOT YET RECRUITING

Hebei Medical University Fourth Hospital

Shijiazhuang, Hebei, 050000, China

RECRUITING

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150000, China

RECRUITING

The First Affiurted Hospital of Soochow University

Suzhou, Jiangsu, 215000, China

NOT YET RECRUITING

Qingdao University Medical College

Qingdao, Shandong, 266000, China

NOT YET RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200000, China

NOT YET RECRUITING

The Second People's Hospital of Sichuan

Chengdu, Sichuang, 610000, China

RECRUITING

Tianjin Medical University Cancer Institute and Hospital

Tianji, Tianji, 300000, China

RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310000, China

NOT YET RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Erlotinib Hydrochloride; Vinorelbine; Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Changli Wang

  Tianjin Medical University Cancer Institute and Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xuefeng Kan

CONTACT

13920870123@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2011
• First Posted: August 5, 2011
• Study Start: May 1, 2011
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2017
• Last Updated: December 23, 2011

Record last verified: 2011-12

Locations

CN (11)