Clinical trial · Interventional
Sorafenib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Phase II Study of the Raf Kinase Inhibitor BAY43-9006 in Patients With Advanced Non-Small Cell Lung Cancer
NCT00098540CI-TRIAL-00025292completedPhase 2ClinicalTrials.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)
This phase II trial is studying how well sorafenib works in treating patients with stage IIIB or stage IV non-small cell lung cancer. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It may also stop the growth of non-small cell lung cancer by blocking blood flow to the tumor.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Stage IIIB Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Stage IV Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| sorafenib tosylate | Drug | Sorafenib Tosylate | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (sorafenib tosylate)
- description
- Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: sorafenib tosylate
- Other: laboratory biomarker analysis
Primary outcomes (1)
- measure
- Confirmed tumor response according to RECIST criteria
- timeFrame
- Up to 5 years
- description
- The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated using the Duffy-Santner approach.
Secondary outcomes (3)
- measure
- Progression-free survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Histologically or cytologically confirmed non-small cell lung cancer (NSCLC), meeting 1 of the following stage criteria:
* Stage IIIB with pleural effusion
* Stage IV
* Measurable disease
* At least 1 lesion ≥ 2.0 cm by conventional techniques OR ≥ 1.0 cm by spiral CT scan
* The following are not considered measurable disease:
* Bone lesions
* Leptomeningeal disease
* Ascites
* Pleural/pericardial effusion
* Inflammatory breast disease
* Lymphangitis cutis/pulmonis
* Abdominal masses not confirmed and followed by imaging techniques
* Cystic lesions
* No known brain metastases, even if treated and stable
* Performance status - ECOG 0-2
* At least 12 weeks
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 10 g/dL
* No bleeding diathesis
* Bilirubin ≤ 2 times upper limit of normal (ULN)
* AST ≤ 3 times ULN (5 times ULN if hepatic metastasis present)
* Creatinine ≤ 1.5 times ULN
* No uncontrolled hypertension
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No known HIV positivity
* HIV negative
* Able to swallow tablets
* No uncontrolled infection
* No other severe underlying disease that would preclude study participation
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or adequately treated noninvasive carcinomas
* No prior immunotherapy, biologic therapy, or gene therapy
* No concurrent prophylactic colony-stimulating factors
* At least 4 weeks since prior low-dose weekly chemotherapy as a radiosensitizer
* No other prior chemotherapy for NSCLC
* No concurrent chemotherapy
* See Chemotherapy
* At least 4 weeks since prior radiotherapy
* No prior radiotherapy to ≥ 30% of bone marrow
* No concurrent radiotherapy
* Concurrent palliative radiotherapy to nontarget lesions (e.g., painful pre-existing bony metastasis) allowed
* Prior adjuvant therapy allowed provided recurrent disease occurred \> 6 months after completion of adjuvant therapy
* No prior systemic therapy for NSCLC, including all novel targeted agents (e.g., gefitinib or erlotinib)
* No concurrent therapeutic anticoagulation
* Prophylactic anticoagulation (e.g., low-dose warfarin) for venous and arterial devices allowed provided PT, INR, and PTT requirements are met
* No other concurrent anticancer agents or therapies
* No other concurrent investigational agents or therapiesReferences
Publications (0)
Data not yet available
No reference posted for this study.