A study of RO5083945 in combination with chemotherapy versus chemotherapy alone in patients with advanced or recurrent non-small cell lung cancer
- Conditions
- ocally advanced (stage IIIb), metastatic (IV) or recurrent, non-small cell lung cancer who have not received prior chemotherapyMedDRA version: 14.0 Level: LLT Classification code 10025076 Term: Lung carcinoma stage III System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.0 Level: LLT Classification code 10025077 Term: Lung carcinoma stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2010-018945-72-GB
- Lead Sponsor
- F.Hoffmann-La Roche
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 93
- adult patients, >/=18 years of age
- advanced, metastatic or recurrent non-small cell lung cancer
- at least 1 measurable disease lesion as per RECIST criteria
- confirmed presence of EGFR in tumor tissue
- ECOG performance status 0-1
- adequate hematological, renal and liver function
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 112
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 48
- prior chemotherapy or treatment with another systemic anti-cancer agent
- radiotherapy within the last 4 weeks, except for limited field palliative radiotherapy for bone pain relief
- history or clinical evidence of CNS metastases
- recent history of poorly controlled hypertension (systolic >180mmHg or diastolic >100mmHg)
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