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
- on-Small Cell Lung CancerMedDRA version: 18.0Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2014-001498-15-NL
- Lead Sponsor
- F. Hoffmann- La Roche Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 17
- 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
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 35
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 18
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: • To evaluate the safety and tolerability of RO5479599 in combination with carboplatin and paclitaxel<br>• To estimate the efficacy of RO5479599 in combination with carboplatin and paclitaxel, as measured by the objective response rate (ORR, defined as complete response [CR] rate + partial response [PR] rate);Secondary Objective: • To evaluate patients for progression-free survival (PFS) and overall survival (OS)<br>• To evaluate disease control rate (DCR, defined as ORR + stable disease [SD] rate)<br>• To describe the PK of RO5479599 in combination with carboplatin and paclitaxel;Primary end point(s): 1. Incidence of adverse events<br>2. Objective response rate (ORR), defined as complete response (CR) rate + partial response (PR) rate at 6 weeks;Timepoint(s) of evaluation of this end point: 1. Up to 30 months<br>2. 6 weeks<br>
- Secondary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: Up to 30 months;Secondary end point(s): 1. Progression-free survival (PFS) <br>2. Outcome Measure: Overall survival (OS)<br>3. Outcome Measure: Disease control rate (DCR)<br>4. Pharmacokinetic parameters derived from serum RO5479599 concentrations<br>