Sorafenib in BAC or Never-Smokers With Lung Adenocarcinoma

A Phase II Trial of Sorafenib in BAC or Never-Smokers With Any Lung Adenocarcinoma

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00456716

Enrollment

Registered

2007-04-05

Start date

2007-03-31

Completion date

2008-12-31

Last updated

2010-03-04

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

Conditions

Lung Cancer

Keywords

BAC lung cancer, adenocarcinoma of the lung

Brief summary

Open label study of sorafenib

Detailed description

Open label study using oral sorafenib 800 mg daily in any stage III-IV BAC lung cancer and Stage III-IV adenocarcinoma of the lung in nonsmokers (less than \< 100 cigarettes lifetime).

Interventions

DRUGsorafenib

400mg po bid

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Age \> 18 * Life expectancy \> 12 weeks * Biopsy-proven BAC or adenocarcinoma * Willing to provide smoking status * Selected IIIB or stage IV cancer that is incompletely resected or unresectable

Exclusion criteria

* O2 saturation \< 88% on room air * Pregnant or nursing women * Surgery or radiation therapy within 4 weeks of starting study * Major heart condition within 6 months of starting therapy * Certain concomitant medications prohibited

Design outcomes

Primary

Measure	Time frame
Response rate	January 2009
One-year survival	January 2009
Median survival	January 2009

Secondary

Measure	Time frame
Median progression-free survival	January 2009
Toxicities	January 2009

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026