OPEN-LABEL PHASE Ib/II, MULTICENTER STUDY OF THE COMBINATION OF RO5479599 WITH CARBOPLATIN AND PACLITAXEL IN PATIENTS WITH ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) OF SQUAMOUS HISTOLOGY WHO HAVE NOT RECEIVED PRIOR CHEMOTHERAPY OR TARGETED THERAPY FOR NSCLC

Completed

• Conditions: gevorderde en/of gemetastaseerde sqNSCLC; cancer; squamous Non-Small Cell Lung Cancer; 10038666

• Registration Number: NL-OMON41018
• Lead Sponsor: Roche Nederland B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 5

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objectives of this study are:<br /><br>• To evaluate the safety and tolerability of RO5479599 in combination with<br /><br>carboplatin and paclitaxel<br /><br>• To estimate the efficacy of RO5479599 in combination with carboplatin and<br /><br>paclitaxel, as measured by the objective response rate (ORR, defined as<br /><br>complete response [CR] rate + partial response [PR] rate) </p><br>