A Study Evaluating RO5479599 in Combination With Carboplatin and Paclitaxel in Patients With Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC) of Squamous Histology
Conditions
Non-Squamous Non-Small Cell Lung Cancer
Conditions: official terms
Carcinoma, Non-Small-Cell Lung - Lung Neoplasms
Study Type
Interventional
Study Phase
Phase 1
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: RO5479599 Type: Drug
Name: carboplatin Type: Drug
Name: paclitaxel Type: Drug
Overall Status
Recruiting
Summary
A multi-center Phase Ib/II study of the combination of RO5479599 with carboplatin and paclitaxel in an every 3 week (q3w) regimen.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Age >/= 18 years

- ECOG performance status (PS) 0 - 1

- Histologically confirmed squamous NSCLC patients

- Locally advanced or metastatic (stage IIIB or IV) squamous NSCLC

- No prior systemic chemotherapy, targeted therapy for metastatic NSCLC

- Evidence of at least one radiologically measurable lesion as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

- Adequate hematological, liver and renal function

- Use of highly effective contraception

Exclusion Criteria:

- Concurrent therapy with any other investigational drug

- History or clinical evidence of central nervous system (CNS) primary tumors or metastases

- Evidence of significant, uncontrolled concomitant diseases, which could affect compliance with the protocol or interpretation of results, including uncontrolled diabetes mellitus and/or significant cardiovascular disease or uncontrolled infection

- Any other diseases, metabolic dysfunction, a physical examination finding or a clinical laboratory finding, giving reasonable suspicion of a disease or condition that would contraindicate the use of an investigational drug

- Major surgery or significant traumatic injury < 28 days prior to the first study treatment infusion (excluding biopsies) or anticipation of the need for major surgery during study treatment

- Pregnant or breast-feeding women

- History of other malignancies that could affect compliance with protocol or interpretation of results. Patients with malignancies diagnosed more than five years prior to study day one, adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer are generally eligible
Locations
Toronto, Ontario, Canada
Status: Recruiting
København, Denmark
Status: Recruiting
Seoul, Korea, Republic of
Status: Recruiting
Amsterdam, Netherlands
Status: Recruiting
Groningen, Netherlands
Status: Recruiting
Barcelona, Spain
Status: Active, not recruiting
Barcelona, Spain
Status: Active, not recruiting
Madrid, Spain
Status: Recruiting
Valencia, Spain
Status: Active, not recruiting
Birmingham, United Kingdom
Status: Not yet recruiting
London, United Kingdom
Status: Not yet recruiting
Start Date
November 2014
Completion Date
August 2018
Sponsors
Hoffmann-La Roche
Source
Hoffmann-La Roche
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page