At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed advanced NSCLC
- ✓Disease progression after at least 2 prior chemotherapy regimens for NSCLC
- ✓Measurable or nonmeasurable disease
- ✓ECOG performance status 0-1
- ✕Prior primary or metastatic brain/meningeal tumors unless clinically and radiographically stable and off therapy for ≥2 months
- ✕Active second malignancy
- ✕Clinically evident congestive heart failure, serious cardiac arrhythmias, or symptoms of coronary heart disease
- ✕Prior exposure to a ras pathway inhibitor
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Double Blind Phase II Study of BAY 43-9006 in Patients With Non-Small Cell Lung Cancer Who Have Failed at Least Two Prior Chemotherapy Regimens
In Brief
A Phase 2 clinical trial evaluating Sorafenib and Placebo for Lung Cancer. Completed, enrolled 342 participants across 141 sites.
Detailed Summary
RATIONALE: Preclinical studies indicate that sorafenib is a potent inhibitor of Raf kinase in vitro and in vivo, with significant dose-dependent, anti-tumor activity in four different human tumor types including colon, pancreatic, lung, and ovarian. This activity was cytostatic in nature and was maintained if dosing was continued. That is, tumor growth is suspended while the drug is administered but returns to baseline rates when the agent is withdrawn. Therefore, the optimal schedule will be an uninterrupted one. To assess the activity of sorafenib in a timely manner and with a meaningful interpretation, a randomized discontinuation design was adopted in the present trial, conducted in a population who were potentially sensitive to sorafenib. PURPOSE: This randomized phase II trial is studying sorafenib to see how well it works compared to placebo in treating patients with refractory non-small cell lung cancer.
Study Details
Timeline
Interventions
Step 1 (induction): Sorafenib was giventwice daily for two cycles to all patients. Patients with progression (PD) discontinued treatment. Those who responded after two cycles continued treatment up to 1 year or until PD. With response after 1 year, patients were given the option to continue treatment until PD. Patients who were stable after the end of induction were then randomized onto Step 2 to either continue sorafenib or receive placebo. Step 2 (randomization): Patients with stable disease after induction will be randomized in a double-blinded manner to placebo or sorafenib. If a patient has progressed, the arm will be unblinded. Patients on placebo with PD can then crossover to receive sorafenib; patients with PD on the sorafenib arm will be removed from the study. Step 3 (crossover): If patients on placebo progressed within 1 year from randomization, they crossed over to the treatment arm and receive sorafenib for up to 1 year or until PD, unacceptable toxicity, or death.
Patients randomized to the placebo arm in step 2 continued receiving placebo until disease progression or one year from randomization. Placebo was given orally twice a day (BID).