Clinical trial · Interventional
Sorafenib in Treating Non-Smokers or Former Light Smokers With Relapsed or Refractory Stage IIIB or Stage IV Non-Small Cell Lung Cancer
A Phase II Study of Single Agent Sorafenib in Non-small Cell Lung Cancer Patients Who Never Smoked or Were Former Light Smokers.
NCT00754923CI-TRIAL-00037463terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how well sorafenib works in treating non-smokers or former light smokers with relapsed or refractory stage IIIB or stage IV non-small cell lung cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| sorafenib | Drug | Sorafenib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment: Sorafenib
- description
- Sorafenib will be administered at a dose of 400 mg taken twice daily, continuously on a 28 day cycle.
- interventionNames
- Drug: sorafenib
Primary outcomes (1)
- measure
- Progression-free Survival at 6 Months
- timeFrame
- 6 months
- description
- Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions", or similar definition as accurate and appropriate
Secondary outcomes (3)
- measure
- Overall Survival Rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed non-small cell lung cancer * Stage IIIB or IV disease * Recurrent disease after prior surgery, chemotherapy, or radiotherapy * No squamous cell histology or mixed tumor with \> 50% squamous cells * Non-smoker (smoked ≤ 100 cigarettes in lifetime) OR former light smoker (smoked \> 100 cigarettes but ≤ 10 pack years AND quit smoking ≥ 1 year ago) * No known brain metastasis * Patients with neurological symptoms must undergo a CT scan or MRI of the brain to exclude brain metastasis PATIENT CHARACTERISTICS: * ECOG(Eastern Cooperative Oncology Group)performance status 0-2 * ANC (Absolute Neutrophil Count)≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * ALT (Alanine Aminotransferase Test) and AST (Aspartate Aminotransferase Test) ≤ 2.5 times upper limit of normal (ULN) * Alkaline phosphatase ≤ 2.5 times ULN * Bilirubin ≤ 1.5 mg/dL * Creatinine clearance ≥ 50 mL/min * INR (International Normalized Ratio) \< 1.5 OR PT/PTT (Prothrombin time/partial thromboplastin time)normal * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective barrier contraception prior to, during, and for ≥ 3 months after completion of study treatment * No cardiac disease, including any of the following: * New York Heart Association class III-IV congestive heart failure * Unstable angina (anginal symptoms at rest) * New-onset angina within the past 3 months * Myocardial infarction within the past 6 months * No cardiac ventricular arrhythmias requiring anti-arrhythmic therapy * No uncontrolled hypertension (i.e., systolic blood pressure \[BP\] \> 150 mm Hg or diastolic BP \> 90 mm Hg) despite optimal medical management * No thrombolic or embolic events (e.g., cerebrovascular accident, including transient ischemic attacks) within the past 6 months * No pulmonary hemorrhage or bleeding event ≥ CTCAE (Common Terminology Criteria for Adverse Events)grade 2 within the past 4 weeks * No other hemorrhage or bleeding event ≥ CTCAE grade 3 within the past 4 weeks * No active clinically serious infection \> CTCAE grade 2 * No serious non-healing wound, ulcer, or bone fracture * No evidence or history of bleeding diathesis or coagulopathy * No known HIV infection or chronic hepatitis B or C * No other malignancy except for any of the following: * Adequately treated basal cell or squamous cell skin cancer * In situ cervical cancer * Other cancer from which the patient has been disease-free for ≥ 5 years with a low probability of recurrence * No condition that impairs the patient's ability to swallow whole pills * No malabsorption problems * No known or suspected allergy to sorafenib tosylate or any agent given in the course of this study * No significant traumatic injury within the past 4 weeks PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No more than one prior systemic chemotherapy treatment for metastatic disease * Prior treatment with EGFR inhibitors is not considered chemotherapy * More than 4 weeks since prior major surgery or open biopsy * No prior sorafenib tosylate * No concurrent St. John's wort or rifampin * Concurrent anticoagulation with warfarin or heparin allowed
References
Publications (0)
Data not yet available
No reference posted for this study.