A study comparing first-line maintenance Tarceva vs Tarceva at the time of disease progression in patients with advanced non-small cell lung cancer (NSCLC)
- Conditions
- Advanced (Stage IIIB or IV) NSCLC previously treated with 4 cycles of a platinum-based chemotherapy (for Traceva®).MedDRA version: 14.0Level: PTClassification code 10029522Term: Non-small cell lung cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.0Level: PTClassification code 10029521Term: Non-small cell lung cancer stage IIIBSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2010-024468-16-FR
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 643
- 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 chemotherapy cycle - ECOG performance status 0-1
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
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
- Prior exposure to agents directed at HER axis (e.g. erlotinib, gefitinib, cetuximab)
- Patients whose tumours harbour an EGFR activating mutation
- Prior chemotherapy or therapy with systemic anti-neoplastic therapy for advanced disease before screening (platinum-based chemotherapy)
- Use of premetrexed in maintenance setting (pemetrexed is allowed during the chemotherapy run-in)
- Patients who have undergone complete tumour resection after responding to the 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method