Cisplatin and Alimta with panitumumaB for Advanced non-squamous Lung cAncer (CABALA Trial): a SICOG multicenter, phase II trial - CABALA
- Conditions
- previously untreated, EGFR + (FISH), advanced, non-squamous, NSCLCMedDRA version: 9.1Level: HLGTClassification code 10029107
- Registration Number
- EUCTR2010-021092-89-IT
- Lead Sponsor
- SOUTHERN ITALY COOPERATIVE ONCOLOGY GROUP
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
- Histological diagnosis of previously untreated, non-squamous, NSCLC, EGFR + (FISH) - Stage IIIb or IV - Age 18-75 - PS ECOG 0-1 - At least 1 measurable lesion (RECIST v. 1.1) - Good main organs function - Written informed consent
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
- Past (within 5 years of study entry) or concurrent neoplasm other than adequately managed in situ carcinoma of the cervix and/or basal cell skin cancer - Clinically detectable brain metastases - Concurrent treatment with other chemotherapeutic, hormonal or biologic antineoplastic agents. - Prior exposure to cisplatin in the adjuvant setting - Previous chemotherapy for metastatic disease - Previous radiotherapy - Clinically significant disease
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