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 MUTATION

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 MUTATION - Sorafenib in K-Ras mutated NSCLC

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON32472

Enrollment

Registered

2010-01-21

Start date

2010-05-01

Completion date

Unknown

Last updated

2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

non-small cell lung cancer

Interventions

Sorafenib 400 mg td po

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
Disease Control Rate	—

Secondary

Measure	Time frame
objective response rate, duration of response, time to disease progression or death, survival	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)