A Study of Tarceva (Erlotinib) in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer Following 4 Cycles of Platinum-based Chemotherapy Without Disease Progressio
- Conditions
- Health Condition 1: null- Non-Small Cell Lung Cancer
- Registration Number
- CTRI/2010/091/002933
- Lead Sponsor
- Roche Products India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 51
1) Histologically documented, locally advanced or recurrent (Stage IIIB) or metastatic (Stage IV) NSCLC.
2) Completion of 4 cycles of an acceptable, standard, platinum-based chemotherapy doublet without progression
3) ECOG PS of 0 ? 1
4) Life expectancy of at least 12 weeks.
5) Granulocyte count ≥ 1,500/mm3, platelet count > 100,000/mm3, hemoglobin ≥ 9.0g/dL,
6) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 x upper limit of normal (ULN) in the absence of liver metastases or up to 5 x ULN in case of liver metastases, alkaline phosphatase (ALP) < 2.5 x ULN (if ALP was ≥ 2.5 x ULN, AST and ALT were required to be < 1.5 x ULN; if ALP was ≥ 2.5 x ULN in the presence of liver metastases, AST and ALT were required to be < 5 x ULN).
7) Normal serum calcium.
8) Written (signed) informed consent
1) Prior exposure to agents directed at the HER axis (eg, gefitinib, cetuximab, trastuzumab).
2) Prior treatment with any monoclonal antibody therapy
3) Serum creatinine > 1.5 ULN and/or creatinine clearance < 60 mL/min.
4) Any unstable systemic disease (including active infections, significant cardiovascular disease, [including myocardial infarction within the previous year], any significant hepatic, renal or metabolic disease) metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of erlotinib or that might affect the interpretation of the results or render the patient at high risk from treatment complications.
5) Pre-existing interstitial lung disease.
6) Any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer).
7) Any inflammatory changes of the surface of the eye
8) Nursing and/or pregnant women.
9) Subjects with reproductive potential not willing to use an effective method of contraception.
10) Received any investigational drug treatment within 4 weeks of start of study treatment.
11) Patients with known active infection with HIV, HBV, or HCV.
12) Known hypersensitivity to erlotinib or any of the component of erlotinib.
13) Any other criteria that contradicts the use of erlotinib as per local label or physicians? discretion.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective of this study is to evaluate Progression free survival rate (PFSR) at 52 weeks in the locally advanced or metastatic NSCLC patients treated with Tarceva® who have not progressed after standard platinum based chemotherapy.Timepoint: at 52 week
- Secondary Outcome Measures
Name Time Method Secondary Objectives<br>? To evaluate the median progression free survival in the study population<br>? To evaluate the median Overall Survival in the study population<br>? To evaluate overall response rate (CR+PR) and disease control rate (CR+PR+SD) in the study population<br>? To evaluate the safety profile of administering erlotinib after standard platinum based chemotherapy in the treatment of NSCLC.<br>? To perform exploratory evaluations of progression free survival rate, median progression free survival, median overall survival, overall response rate and disease control rate in EGFR mutation positive and wild type patients, in patients whose EGFR mutation status are available or tumor ? tissue blocks are available for EGFR mutation testing.Timepoint: Nil