A 3rd/4th Line Placebo-controlled Trial of Sorafenib in Patients With Predominantly Non Squamous Non-Small Cell Lung Cancer (NSCLC).

Bayer703 enrolled

Overview

The purpose of the study is to see if sorafenib plus best supportive care (i.e. in addition to the non-cancer treatments patients would normally receive) is an effective treatment for lung cancer compared to best supportive care alone. The safety and tolerability of the two treatment groups will also be compared. The goal of the study is to test the ability of sorafenib to improve survival compared to best supportive care alone.

Acronyms used in Adverse Events section: Disseminated intravascular coagulation (DIC), International normalized ratio (INR), Atrioventricular (AV), Gastrointestinal (GI), Not otherwise specified (NOS), Common Terminology Criteria for Adverse Events (CTCAE), Absolute neutrophil count (ANC), Central nervous system (CNS), Acute respiratory distress syndrome (ARDS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

703

Conditions

Carcinoma Non-Small-Cell Lung

Interventions

Sorafenib (Nexavar, BAY43-9006)DRUG

Sorafenib 400 mg twice daily (BID)

PlaceboDRUG

Placebo - 2 tablets twice daily (BID)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Ability to understand and willingness to sign a written Informed Consent * Advanced relapsed or refractory predominantly non squamous NSCLC. The diagnosis must have been confirmed cyto-/ histologically * Patients must have measurable or non-measurable disease * At least two but not more than three prior standard treatment regimens for NSCLC * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * Male or female subjects \>/= 18 years of age (\>/=20 for Japan) at the time of Informed Consent * Life expectancy of at least 12 weeks * Ability to swallow oral medication * Both men and women using adequate barrier birth control measures during the course of the trial and 4 weeks after the completion of trial * Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to start of the study drug: * Haemoglobin \> 9.0 g/dl * Absolute neutrophil count (ANC) \>1,500/mm3 * Platelet count \>/= 100,000/µl * Total bilirubin \</=1.5 x the upper limit of normal * Alanine aminotransferase (ALT) \< 2.5 x upper limit of normal (\</= 5 x upper limit of normal in patients with liver metastases) Aspartate aminotransferase (AST) \< 2.5 x upper limit of normal (\</= 5 x upper limit of normal in patients with liver metastases) * Alkaline phosphatase \< 4 x upper limit of normal (\</= 5 x upper limit of normal in patients with liver metastases) * Prothrombin Time (PT)-International Normalized Ratio (INR) or Partial Thromboplastin Time (PTT) \< 1.5 x upper limit of normal * Serum creatinine \< 1.5 x upper limit of normal * Calculated creatinine clearance of \>/= 50 mL/min Exclusion Criteria: * NSCLC patients with predominantly squamous cell carcinoma histology Excluded medical conditions: * History of cardiac disease: Congestive heart failure, Active coronary artery disease (CAD), Cardiac arrhythmias (\>Grade 2 NCI-CTCAE \[National Cancer Institute-Common Terminology Criteria for Adverse Events\] vers. 3.0) * Uncontrolled hypertension despite two anti-hypertensive medications * History of Human immunodeficiency virus (HIV) infection or chronic hepatitis B or C * History of organ allograft * Active clinically serious infections (\> grade 2 NCI-CTCAE vers. 3.0) * Patients with seizure disorder requiring medication * Patients with evidence or history of bleeding diathesis or coagulopathy * Patients undergoing renal dialysis * Pulmonary hemorrhage/ bleeding event \>/= CTCAE grade 2 within four weeks prior to the first dose of the study drug * Any other hemorrhage/ bleeding event \>/= CTCAE grade 3 within four weeks prior to the first dose of the study drug * Thrombotic or embolic venous or arterial events such as cerebrovascular accident * Pregnant or breast-feeding women. * Any condition which could affect the absorption or pharmacokinetics of the study drug * Prior treatment with other Vascular Endothelial Growth Factor (VEGF) (R) inhibitors, including compounds that impact vascularity (i.e. sunitinib, thalidomide, vandetanib, vascular disrupting agents \[VDA\], VEGF-trap and other experimental agents of this class). Only bevacizumab (Avastin) is permitted.

Locations (182)

Outcomes

Primary Outcomes

Overall Survival

Overall survival (OS) was defined as the time from date of randomization to date of death due to any cause. Overall survival of subjects alive at the time of analysis will be censored at their last date of follow-up or database cut off date whichever came first.

Time frame: From randomization of the first subject until 36 months later

Secondary Outcomes

Progression-free Survival

Progression-free survival (PFS) was defined as the time from date of randomization to date of first observed disease progression (radiological or clinical, whichever is earlier) or death due to any cause, if death occurs before progression is documented. Progressive Disease (PD) is defined as at least a 20% increase in the sum of longest diameter (LD) of measured lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Appearance of new lesions will also constitute progressive disease. In exceptional circumstances unequivocal progression of a non-measured lesion may be accepted as evidence of disease progression.

Time frame: From randomization of the first subject until 36 months later assessed every 6 weeks

Disease Control

Disease control (DC) was defined as the proportion of patients whose best response was Complete Response \[CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target)\] or Partial Response \[PR: at least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD\] or Stable Disease \[SD: steady state of disease which was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease (PD)\].

Time frame: From randomization of the first subject until 36 months later assessed every 6 weeks

Objective Tumor Response

Objective tumor response was defined as the proportion of patients whose best response was Complete Response \[CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target)\] or Partial Response \[PR: at least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD\] over the whole duration of study.

Data from ClinicalTrials.gov

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