A PHASE II STUDY OF SORAFENIB IN PATIENTS WITH LOCALLY ADVANCED AND/OR METASTATIC (STAGE IIIB OR IV) NON-SMALL CELL LUNG CANCER (NSCLC) WITH A K-RAS MUTATIO

Phase 2

Completed

• Conditions: non-small cell lung cancer; 10038666

• Registration Number: NL-OMON32472
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 48

Inclusion Criteria

1. Histologically advanced NSCLC stage IIIB or IV harbouring a K-RAS mutation
2. Disease progression after at least 1 prior chemotherapy regimen that should include a platinum doublet
3. Age > 18 years.
4. ECOG Performance Status of 0-2
5. Subjects with at least one uni-dimensional (for RECIST) measurable lesion. Lesions must be measured by CT-scan.
6. Adequate bone marrow, liver and renal function
9. Written informed consent

Exclusion Criteria

1. History of cardiac disease: congestive heart failure >NYHA class 2; active CAD (MI more than 6 mo prior to study entry is allowed); cardiac arythmias requiring anti-arythmic therapy( beta blockers or digoxin are permitted) or uncontrolled hypertension.
2. History of HIV infection or chronic hepatitis B or C.
3. Active clinically serious infections (> grade 2 NCI-CTC version 3.0)
4. Symptomatic metastatic brain or meningeal tumors (unless the patient is > 1 months from definitive radiotherapy and off steroids)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Disease Control Rate</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>objective response rate, duration of response, time to disease progression or<br /><br>death, survival </p><br>