A Phase III, Multi-center, Placebo-Controlled Trial of Sorafenib (BAY43-9006) in Patients With Relapsed or Refractory Advanced Predominantly Non Squamous Non-Small Cell Lung Cancer (NSCLC) After 2 or 3 Previous Treatment Regimens for Advanced Disease
Overview
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Bayer
- Enrollment
- 703
- Primary Endpoint
- Overall Survival
Overview
Brief Summary
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.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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:
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
Arms & Interventions
Sorafenib (Nexavar, BAY43-9006)
Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
Intervention: Sorafenib (Nexavar, BAY43-9006) (Drug)
Placebo
Participants received 2 tablets of placebo orally twice daily (BID)
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Overall Survival
Time Frame: From randomization of the first subject until 36 months later
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.
Secondary Outcomes
- Progression-free Survival(From randomization of the first subject until 36 months later assessed every 6 weeks)
- Disease Control(From randomization of the first subject until 36 months later assessed every 6 weeks)
- Objective Tumor Response(From randomization of the first subject until 36 months later assessed every 6 weeks)
- Time to Progression(From randomization of the first subject until 36 months later assessed every 6 weeks)
- Mean Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire for Palliative Care (EORTC QLQ-C15-PAL) - Global Health Status(Baseline and up to End of treatment (up to Cycle 41, 21 days per cycle))
- Mean Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) - Dyspnea(Baseline and up to End of treatment (up to Cycle 41, 21 days per cycle))
- Mean Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) - Coughing Subscale(Baseline and up to End of treatment (up to Cycle 41, 21 days per cycle))
- Mean Change From Baseline in EuroQol-5D (EQ-5D) - Index Score(Baseline and up to End of treatment (up to Cycle 41, 21 days per cycle))
- Mean Change From Baseline in EuroQol-5D (EQ-5D) - VAS Score(Baseline and up to End of treatment (up to Cycle 41, 21 days per cycle))