A randomized, double-blind, placebo-controlled Phase III study of first-line maintenance Tarceva vs Tarceva at the time of disease progression in patients with advanced non-small cell lung cancer (NSCLC) who have not progressed following 4 cycles of platinum-based chemotherapy.
- Conditions
- non-small-cell lung carcinoma (NSCLC)10038666
- Registration Number
- NL-OMON35789
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 32
- Adult patients, >/<= 18 years of age (or >/<= legal age of consent if greater than 18)
- Advanced or recurrent (Stage IIIb) or metastatic (Stage IV) non-small cell lung cancer (NSCLC)
- Completion of 4 cycles of platinum-based chemotherapy without progression (end of last cycle - ECOG performance status 0-1
(for complete inclusion criteria see protocol p34-35)
- Prior exposure to agents directed at HER axis (e.g. erlotinib, gafitinib, cetuximab)
- Patients whose tumours harbour EGFR activating mutation
- Prior chemotherapy or therapy with systemic anti-neoplastic therapy for advanced disease before screening (platinum-based chemotherapy)
- Use of pemetrexed in maintenance setting (pemetrexed is allowed during the chemotherapy run-in)
- Patients who have undergone complete tumour resection after responding to platinum-based chemotherapy during the screening phase
- Any other malignancies within 5 years, except for curatively resected carcinoma in situ of the cervix, basal or squamous cell skin cancer, ductal carcinoma in situ or organ confined prostate cancer
- CNS metastases or spinal cord compression that has not been definitely treated with surgery and/or radiation, or treated CNS metastases or spinal cord compression without stable disease for >/=2 months
- HIV, hepatitis B or hepatitis C infection
- Any inflammatory changes of the surface of the eye
(for complete exclusion criteria see protocol p35-36)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>ASSESSMENTS OF:<br /><br>- EFFICACY (Primary) Overall Survival<br /><br>- EFFICACY (Secondary) Progression Free Survival (RECIST) and Response (RECIST)<br /><br>- SAFETY Safety of the treatment will be evaluated by: adverse events,<br /><br>laboratory tests, vital signs, electrocardiogram and performance status.<br /><br>All subjects who received at least one dose of treatment will be included in<br /><br>the safety evaluation.</p><br>
- Secondary Outcome Measures
Name Time Method