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

NCT ID: NCT00863746

Last Updated: 2015-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 703 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2013-04-30

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).

Conditions

Carcinoma; Non-Small-Cell Lung

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Sorafenib (Nexavar, BAY43-9006)

Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)

Group Type: EXPERIMENTAL

Sorafenib (Nexavar, BAY43-9006)

Intervention Type: DRUG

Sorafenib 400 mg twice daily (BID)

Placebo

Participants received 2 tablets of placebo orally twice daily (BID)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo - 2 tablets twice daily (BID)

Interventions

Sorafenib (Nexavar, BAY43-9006)

Sorafenib 400 mg twice daily (BID)

Intervention Type: DRUG

Placebo

Placebo - 2 tablets twice daily (BID)

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Fayetteville, Arkansas, United States

Stanford, California, United States

Philadelphia, Pennsylvania, United States

Ramos Mejía, Buenos Aires, Argentina

Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina

Córdoba, Córdoba Province, Argentina

Córdoba, Córdoba Province, Argentina

Rosario, Santa Fe Province, Argentina

Rosario, Santa Fe Province, Argentina

Santa Fé, , Argentina

Vienna, Vienna, Austria

Graz, , Austria

Linz, , Austria

Antwerp, , Belgium

Bruxelles - Brussel, , Belgium

Charleroi, , Belgium

Genk, , Belgium

Brasília, Federal District, Brazil

Belo Horizonte, Minas Gerais, Brazil

Porto Alegre, Rio Grande do Sul, Brazil

Porto Alegre, Rio Grande do Sul, Brazil

Santo André, São Paulo, Brazil

São José dos Campos, São Paulo, Brazil

São Paulo, São Paulo, Brazil

São Paulo, São Paulo, Brazil

Plovdiv, , Bulgaria

Sofia, , Bulgaria

Sofia, , Bulgaria

Varna, , Bulgaria

Varna, , Bulgaria

Montreal, Quebec, Canada

Santiago, Santiago Metropolitan, Chile

Santiago, , Chile

Guangzhou, Guangdong, China

Nanjing, Jiangsu, China

Chengdu, Sichuan, China

Hangzhou, Zhejiang, China

Hangzhou, Zhejiang, China

Beijing, , China

Beijing, , China

Beijing, , China

Beijing, , China

Guangzhou, , China

Shanghai, , China

Shanghai, , China

Caen, , France

Dijon, , France

La Roche-sur-Yon, , France

La Tronche, , France

Lille, , France

Lyon, , France

Saint-Herblain, , France

Tours, , France

Heidelberg, Baden-Wurttemberg, Germany

Karlsruhe, Baden-Wurttemberg, Germany

Mannheim, Baden-Wurttemberg, Germany

Ulm, Baden-Wurttemberg, Germany

Gauting, Bavaria, Germany

München, Bavaria, Germany

Hamburg, City state of Hamburg, Germany

Kassel, Hesse, Germany

Cologne, North Rhine-Westphalia, Germany

Großhansdorf, Schleswig-Holstein, Germany

Bad Berka, Thuringia, Germany

Athens, , Greece

Heraklion, , Greece

Thessaloniki, , Greece

Shatin, N.T, Hong Kong

Hong Kong, , Hong Kong

Kowloon, , Hong Kong

Budapest, , Hungary

Budapest, , Hungary

Edelény, , Hungary

Farkasgyepű, , Hungary

Törökbálint, , Hungary

Zalaegerszeg, , Hungary

Mumbai, Maharashtra, India

Pune, Maharashtra, India

Kerala, , India

Bandung, , Indonesia

Jakarta, , Indonesia

Zrifin, Israel, Israel

Holon, , Israel

Jerusalem, , Israel

Jerusalem, , Israel

Kfar Saba, , Israel

Petah Tikva, , Israel

Rozzano, Milano, Italy

Monza, Monza-Brianza, Italy

Orbassano, Torino, Italy

Avellino, , Italy

Genova, , Italy

Livorno, , Italy

Parma, , Italy

Perugia, , Italy

Roma, , Italy

Nagoya, Aichi-ken, Japan

Kashiwa, Chiba, Japan

Fukuoka, Fukuoka, Japan

Akashi, Hyōgo, Japan

Sakai, Osaka, Japan

Sayama, Osaka, Japan

Itabashi-ku, Tokyo, Japan

Koto-ku, Tokyo, Japan

Amsterdam, , Netherlands

Harderwijk, , Netherlands

Heerlen, , Netherlands

Helmond, , Netherlands

Nieuwegein, , Netherlands

Zwolle, , Netherlands

Lahore, Punjab Province, Pakistan

Karachi, Sindh, Pakistan

Callao, , Peru

Lima, , Peru

Lima, , Peru

Lima, , Peru

Lima, , Peru

San Borja, , Peru

Cebu City, , Philippines

Manila, , Philippines

Metro Manila, , Philippines

Quezon City, , Philippines

Kielce, , Poland

Krakow, , Poland

Olsztyn, , Poland

Rzeszów, , Poland

Szczecin, , Poland

Warsaw, , Poland

Kazan', , Russia

Moscow, , Russia

Moscow, , Russia

Moscow, , Russia

Saint Petersburg, , Russia

Yaroslavl, , Russia

Singapore, , Singapore

Singapore, , Singapore

Port Elizabeth, Eastern Cape, South Africa

Johannesburg, Gauteng, South Africa

Prietoria, Gauteng, South Africa

Durban, KwaZulu-Natal, South Africa

Cape Town, Western Cape, South Africa

Seoul, Seoul Teugbyeolsi, South Korea

Seoul, , South Korea

Seoul, , South Korea

Seoul, , South Korea

Seoul, , South Korea

Barcelona, Barcelona, Spain

Barcelona, Barcelona, Spain

Cruces/Barakaldo, Bilbao, Spain

Lleida, Lleida, Spain

Lugo, Lugo, Spain

Madrid, Madrid, Spain

Málaga, Málaga, Spain

Ourense, Ourense, Spain

Seville, Sevilla, Spain

Zamora, Zamora, Spain

Falun, , Sweden

Gothenburg, , Sweden

Linköping, , Sweden

Lund, , Sweden

Stockholm, , Sweden

Kaohsiung City, , Taiwan

Taichung, , Taiwan

Taichung, , Taiwan

Taipei, , Taiwan

Taoyuan District, , Taiwan

Bangkok, , Thailand

Chiang Mai, , Thailand

Songkhla, , Thailand

Ankara, , Turkey (Türkiye)

Instanbul, , Turkey (Türkiye)

Istanbul, , Turkey (Türkiye)

Izmir, , Turkey (Türkiye)

Kocaeli, , Turkey (Türkiye)

Bristol, Avon, United Kingdom

Cambridge, Cambridgeshire, United Kingdom

London, London, United Kingdom

London, London, United Kingdom

Greater Manchester, Manchester, United Kingdom

Sutton, Surrey, United Kingdom

Leeds, West Yorkshire, United Kingdom

Aberdeen, , United Kingdom

Countries

United States; Argentina; Austria; Belgium; Brazil; Bulgaria; Canada; Chile; China; France; Germany; Greece; Hong Kong; Hungary; India; Indonesia; Israel; Italy; Japan; Netherlands; Pakistan; Peru; Philippines; Poland; Russia; Singapore; South Africa; South Korea; Spain; Sweden; Taiwan; Thailand; Turkey (Türkiye); United Kingdom

Other Identifiers

2008-006914-62

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

13266

Identifier Type: -

Identifier Source: org_study_id