Advanced (stage IIIB or IV) Non Small Cell Lung Cancer (NSCLC) MedDRA version: 9.1 Level: LLT Classification code 10029521 Term: Non-small cell lung cancer stage IIIB
Conditions
Interventions
Product Name: Vandetanib
Product Code: ZD6474
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Vandetanib
CAS Number: 338992-00-0
Current Sponsor code: ZD6474
Concentration unit: mg millig
Sponsors
ASTRAZENECA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provision of informed consent 2. Female or male aged 70 years or above 3. Histologic or cytologic confirmation of advanced NSCLC (stage IIIB with supraclavicular lymph node metastases or pleural effusion or stage IV) on entry into study 4. No prior anti-cancer therapies except in the adjuvant setting 5. WHO Performance status 0 - 2 6. One or more measurable lesions at least 10 mm in the longest diameter (LD) by spiral CT scan or 20 mm with conventional techniques according to RECIST criteria 7. Life expectancy of 12 weeks or longer Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Mixed small cell and non-small cell lung cancer histology 2. Patients have received prior anti-cancer therapy except in the adjuvant setting 3. Prior treatment with gemcitabine 4. Prior treatment with VEGFR TKIs (previous treatment with bevacizumab [Avastin] in the adjuvant setting is permitted) 5. Brain metastases or spinal cord compression, unless treated at least 4 weeks before entry, and stable without steroid treatment for 10 days 6. The last radiation therapy within 4 weeks before the start of study therapy, not including local palliative radiation 7. The last dose of prior chemotherapy or other anti-cancer therapy is discontinued less than 3 weeks before the start of study therapy (6 weeks for nitrosoureas, mitomycin, and suramin) 8. Major surgery within 4 weeks before entry, or incompletely healed surgical incision Others are specificied in the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to demonstrate an improvement in Progression-Free Survival (PFS) for the combination of vandetanib plus gemcitabine (Gemzar) compared with gemcitabine plus placebo in chemonaïve (not including an adjuvant regimen) patients aged ≥ 70 years with advanced NSCLC;Secondary Objective: The secondary objectives of the study are: 1. To evaluate the overall survival (OS) for vandetanib in combination with gemcitabine compared with gemcitabine plus placebo 2. To evaluate the proportion of patients alive at 1-year for vandetanib in combination with gemcitabine compared with gemcitabine plus placebo. 3. To evaluate the overall objective response rate (ORR) (complete response [CR] + partial response [PR]), disease control rate (DCR) (CR + PR + stable disease [SD] > 6 weeks) and duration of response (DOR) for vandetanib in combination with gemcitabine compared with gemcitabine plus placebo 4. To study the tolerability and safety of vandetanib in combination with gemcitabine in chemonaïve (not including an adjuvant regimen) patients aged ≥ 70 years with locally advanced or metastatic NSCLC.;Primary end point(s): The primary outcome variable of this study is progression free survival PFS, which is defined as the number of days from randomisation to objective disease progression. Further detail is given in the Protocol | — |
Countries
Italy
Outcome results
None listed