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
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01702714
Recruitment Status :
(Project Team decision)
This open-label, multicenter, non-randomized, dose-escalating phase Ib study with an expansion cohort will determine the recommended Phase II dose and schedule to investigate safety, tolerability, and activity 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. Cohorts of patients will receive escalating doses of RO5083945 in combination with up to 6 cycles of cisplatin and gemcitabine or carboplatin and paclitaxel. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.
A MULTICENTER, OPEN-LABEL PHASE IB 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.
Study Start Date :
Estimated Primary Completion Date :
Estimated Study Completion Date :
Resource links provided by the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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)