Conditions: Non-Small Cell Lung Cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 8
Healthy volunteers: no

Brief summary:
Sorafenib has demonstrated in vivo anti-tumor efficacy. This trial will evaluate the safety and preliminary efficacy of sorafenib following chemoradiation in locally advanced NSCLC.

Detailed description:
Outline: This is a multi-center study.

Chemotherapy/radiation therapy (2 cycles)

* Cisplatin 50 mg/m2 IV days 1 and 8 of 28 day cycle
* Etoposide 50 mg/m2 IV days 1-5 of 28 day cycle
* Concurrent chest radiation (planned dose is 5940 cGy with an additional, optional boost of 1080 cGy to a total allowed dose of 7020 cGy) with the following:

Maintenance therapy of Sorafenib 400 mg PO BID of 28 day cycle, to begin a minimum of 6 and maximum of 9 weeks from completion of chemo-radiotherapy until PD, intolerable toxicity, or up to 1 year.

Patients with progressive disease will discontinue treatment.

ECOG performance status 0 or 1

Hematopoietic:

* Absolute neutrophil count (ANC) ≥ 1500 mm3
* Platelet count ≥ 100,000 mm3
* Hemoglobin ≥ 9 g/dL
* PT or INR \< 1.5 x ULN unless on anti-coagulant therapy
* PTT \< 1.5 x ULN unless on anti-coagulant therapy

Hepatic:

* Bilirubin ≤ 1.5 x ULN
* ALT ≤ 2.5 x ULN (≤ 5 x ULN for patients with liver involvement)
* AST ≤ 2.5 x ULN (≤ 5 x ULN for patients with liver involvement)

Renal:

* Creatinine \< 1.5 X upper limit of normal (ULN)

Cardiovascular:

* No significant history of cardiac disease: Congestive heart failure \> class II NYHA.
* Patients must not have unstable angina (anginal symptoms at rest) or new onset angina (began within 90 days prior to registration for initial therapy) or myocardial infarction within 6 months prior to registration for initial therapy.

Respiratory:

* FEV1 ≥ 1 liter by spirometry within 60 days prior to registration for initial therapy.

Arms:
arm 1: Cisplatin/Etoposide/Radiotherapy followed by Sorafenib in patients with inoperable stage III non-small cell lung cancer

Interventions: intervention 1: Cisplatin intervention 2: Etoposide intervention 3: Radiotherapy intervention 4: Sorafenib
Intervention descriptions: intervention 1: Cisplatin 50 mg/m2 IV, days 1 and 8 of 28 day cycle intervention 2: Etoposide 50 mg/m2 IV, days 1-5 of 28 day cycle intervention 3: Concurrent chest radiation (planned dose is 5940 cGy with an additional, optional boost of 1080 cGy to a total allowed dose of 7020 cGy) intervention 4: Maintenance therapy of Sorafenib 400 mg PO BID, to begin a minimum of 6 and maximum of 9 weeks from completion of chemo-radiotherapy until PD, intolerable toxicity, or up to 6 months

Protocol document: