A Study of RO5083945 in Combination With Cisplatin and Gemcitabine or Carboplatin and Paclitaxel in Patients With Advanced or Recurrent Non-Small Cell Lung Cancer of Squamous Histology Who Have Not Received Prior Chemotherapy for The Metastatic Disease

This is an interventional treatment trial for Non-Squamous Non-Small Cell Lung Cancer Read More

Inclusion Criteria:

• Adult patients, >/= 18 years of age
• Locally advanced (stage IIIB, excluding patients who are candidates for chemo-radiotherapy or radical thoracic radiotherapy), metastatic (stage IV) or recurrent squamous non-small cell lung cancer (NSCLC)
• Histologically documented squamous NSCLC. Mixed tumors should be categorized according to the predominant cell type
• Histological tumor tissue sample from initial diagnosis or new tumor biopsy representative of the disease
• Patients who have received adjuvant chemotherapy are eligible if the last administration of the prior adjuvant regimen occurred at least 3 months prior to enrollment
• At least one measurable disease lesion as per RECIST 1.1 criteria
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Adequate hematological, liver and renal function
• Females of childbearing potential must commit to using a reliable and appropriate method of contraception until at least 3 months after the end of the last dose of study treatment

Exclusion Criteria:

• Prior chemotherapy (excluding neoadjuvant/adjuvant chemotherapy/chemo-radiotherapy) or treatment with another systemic anti-cancer agent (e.g. monoclonal antibody, tyrosine kinase inhibitor)
• Radiotherapy within the last 4 weeks prior to first dosing, except for limited field palliative radiotherapy for bone pain relief
• Treatment with any other investigational agent within 30 days prior to starting study treatment or participation in another clinical trial (e.g. CTC blood collection) within 7 days prior to starting study treatment
• Historical or clinical evidence of central nervous system (CNS) metastases (except for previously treated CNS metastases in patients that are asymptomatic, have had no evidence of active CNS metastases for >/= 3 months prior to first dose and have had no requirement for steroids or enzyme-inducing anticonvulsants in the last 14 days)
• Recent history of poorly controlled hypertension (systolic >180 mmHg or diastolic >100 mmHg)
• Severe uncontrolled illness, including poorly controlled diabetes mellitus and active or uncontrolled infection
• Hypersensitivity to the active substance or to any excipients or to any of the study drugs including premedication (corticosteroids, anti-histamine, paracetamol)
• Pregnant or breastfeeding women