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

NCT00863746 | Completed Phase 3 Results DMC

• 2 other identifiers: 132662008-006914-62
• Study Type: interventional
• Target: 703
• Locations: 34 countries
• Sites: 182

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.

Conditions

Carcinoma; Non-Small-Cell Lung

Keywords

Non-Small Cell Lung Cancer (NSCLC); Sorafenib

Outcome Measures

Primary Outcomes (1)

• 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.

  From randomization of the first subject until 36 months later

Secondary Outcomes (9)

• 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)

Study Arms (2)

Sorafenib (Nexavar, BAY43-9006)

EXPERIMENTAL

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

Drug: Sorafenib (Nexavar, BAY43-9006)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Sorafenib (Nexavar, BAY43-9006) DRUG

Sorafenib 400 mg twice daily (BID)

Sorafenib (Nexavar, BAY43-9006)

Placebo DRUG

Placebo - 2 tablets twice daily (BID)

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (182)

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Fayetteville, Arkansas, 72703, United States

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Stanford, California, 94305, United States

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Philadelphia, Pennsylvania, 19107, United States

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Ramos Mejía, Buenos Aires, B1704ESN, Argentina

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Buenos Aires, Ciudad Auton. de Buenos Aires, C1430ERF, Argentina

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Córdoba, Córdoba Province, 5000, Argentina

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Córdoba, Córdoba Province, X5016KEH, Argentina

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Rosario, Santa Fe Province, 2000, Argentina

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Rosario, Santa Fe Province, S2000DSK, Argentina

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Santa Fé, S3000FFV, Argentina

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Vienna, Vienna, 1090, Austria

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Graz, 8036, Austria

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Linz, 4010, Austria

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Antwerp, 2020, Belgium

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Bruxelles - Brussel, 1200, Belgium

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Charleroi, 6000, Belgium

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Genk, 3600, Belgium

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Brasília, Federal District, 70680-650, Brazil

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Belo Horizonte, Minas Gerais, 30150-281, Brazil

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Porto Alegre, Rio Grande do Sul, 90050 170, Brazil

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Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

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Santo André, São Paulo, 09020 110, Brazil

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São José dos Campos, São Paulo, 12245750, Brazil

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São Paulo, São Paulo, 01224-010, Brazil

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São Paulo, São Paulo, 05651-900, Brazil

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Plovdiv, Bulgaria

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Sofia, 1784, Bulgaria

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Sofia, Bulgaria

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Varna, 9002, Bulgaria

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Varna, 9010, Bulgaria

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Montreal, Quebec, H2W 1S6, Canada

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Santiago, Santiago Metropolitan, 838-0455, Chile

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Santiago, 838-0456, Chile

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Guangzhou, Guangdong, 510060, China

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Nanjing, Jiangsu, 210002, China

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Chengdu, Sichuan, 610041, China

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Hangzhou, Zhejiang, 310016, China

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Hangzhou, Zhejiang, 310022, China

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Beijing, 100021, China

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Beijing, 100071, China

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Beijing, 100142, China

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Beijing, 100853, China

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Guangzhou, 510080, China

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Shanghai, 200030, China

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Shanghai, 200433, China

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Caen, 14073, France

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Dijon, 21000, France

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La Roche-sur-Yon, 85025, France

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La Tronche, 38700, France

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Lille, 59020, France

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Lyon, 69317, France

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Saint-Herblain, 44805, France

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Tours, 37044, France

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Heidelberg, Baden-Wurttemberg, 69126, Germany

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Karlsruhe, Baden-Wurttemberg, 76137, Germany

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Mannheim, Baden-Wurttemberg, 68167, Germany

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Ulm, Baden-Wurttemberg, 89091, Germany

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Gauting, Bavaria, 82131, Germany

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München, Bavaria, 80336, Germany

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Hamburg, Hamburg, 21075, Germany

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Kassel, Hesse, 34125, Germany

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Cologne, North Rhine-Westphalia, 51109, Germany

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Großhansdorf, Schleswig-Holstein, 22927, Germany

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Bad Berka, Thuringia, 99437, Germany

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Athens, 11527, Greece

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Heraklion, 711 10, Greece

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Thessaloniki, 570 10, Greece

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Shatin, N.T, Hong Kong

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Hong Kong, Hong Kong

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Kowloon, Hong Kong

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Budapest, 1125, Hungary

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Budapest, 1529, Hungary

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Edelény, 3780, Hungary

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Farkasgyepű, 8582, Hungary

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Törökbálint, 2045, Hungary

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Zalaegerszeg, 8900, Hungary

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Mumbai, Maharashtra, 422004, India

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Pune, Maharashtra, 411001, India

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Kerala, 682304, India

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Bandung, 40161, Indonesia

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Jakarta, 11420, Indonesia

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Zrifin, Israel, 6093000, Israel

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Holon, Israel

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Jerusalem, 9112001, Israel

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Jerusalem, 9372212, Israel

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Kfar Saba, 4428164, Israel

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Petah Tikva, 4941492, Israel

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Rozzano, Milano, 20089, Italy

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Monza, Monza-Brianza, 20052, Italy

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Orbassano, Torino, 10043, Italy

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Avellino, 83100, Italy

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Genova, 16132, Italy

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Livorno, 57124, Italy

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Parma, 43100, Italy

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Perugia, 06156, Italy

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Roma, 00151, Italy

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Nagoya, Aichi-ken, 464-8681, Japan

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Kashiwa, Chiba, 277-8577, Japan

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Fukuoka, Fukuoka, 811-1395, Japan

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Akashi, Hyōgo, 673-8558, Japan

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Sakai, Osaka, 591-8555, Japan

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Sayama, Osaka, 589-8511, Japan

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Itabashi-ku, Tokyo, 173-8606, Japan

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Koto-ku, Tokyo, 135-8550, Japan

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Amsterdam, 1081HV, Netherlands

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Harderwijk, 3844 DG, Netherlands

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Heerlen, 6419 PC, Netherlands

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Helmond, 5707 HA, Netherlands

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Nieuwegein, 3435 CM, Netherlands

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Zwolle, 8025 AB, Netherlands

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Lahore, Punjab Province, 54000, Pakistan

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Karachi, Sindh, 74700, Pakistan

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Callao, CALLAO 2, Peru

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Lima, LIMA 11, Peru

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Lima, LIMA 1, Peru

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Lima, LIMA 27, Peru

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Lima, LIMA 34, Peru

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San Borja, Peru

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Cebu City, 6000, Philippines

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Manila, 1000, Philippines

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Metro Manila, 1000, Philippines

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Quezon City, 1104, Philippines

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Kielce, 25-316, Poland

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Krakow, 31-115, Poland

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Olsztyn, 10-357, Poland

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Rzeszów, 35-021, Poland

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Szczecin, 70-891, Poland

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Warsaw, 01-138, Poland

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Kazan', 420029, Russia

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Moscow, 105 005, Russia

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Moscow, 115478, Russia

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Moscow, 129128, Russia

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Saint Petersburg, 198255, Russia

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Yaroslavl, 150054, Russia

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Singapore, 119228, Singapore

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Singapore, 308433, Singapore

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Port Elizabeth, Eastern Cape, 6045, South Africa

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Johannesburg, Gauteng, 2196, South Africa

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Prietoria, Gauteng, 0084, South Africa

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Durban, KwaZulu-Natal, 4126, South Africa

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Cape Town, Western Cape, 7500, South Africa

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Seoul, Seoul Teugbyeolsi, 110-744, South Korea

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Seoul, 135-710, South Korea

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Seoul, 136-705, South Korea

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Seoul, 137-701, South Korea

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Seoul, 138-736, South Korea

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Barcelona, Barcelona, 08025, Spain

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Barcelona, Barcelona, 08036, Spain

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Cruces/Barakaldo, Bilbao, 48903, Spain

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Lleida, Lleida, 25198, Spain

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Lugo, Lugo, 27003, Spain

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Madrid, Madrid, 28040, Spain

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Málaga, Málaga, 29010, Spain

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Ourense, Ourense, 32005, Spain

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Seville, Sevilla, 41013, Spain

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Zamora, Zamora, 49021, Spain

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Falun, 791 82, Sweden

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Gothenburg, 413 45, Sweden

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Linköping, 581 85, Sweden

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Lund, 221 85, Sweden

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Stockholm, 171 76, Sweden

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Kaohsiung City, 80756, Taiwan

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Taichung, 404, Taiwan

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Taichung, 40705, Taiwan

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Taipei, 10016, Taiwan

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Taoyuan District, 333, Taiwan

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Bangkok, 10700, Thailand

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Chiang Mai, 50200, Thailand

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Songkhla, 90110, Thailand

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Ankara, Turkey (Türkiye)

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Instanbul, 34662, Turkey (Türkiye)

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Istanbul, Turkey (Türkiye)

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Izmir, Turkey (Türkiye)

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Kocaeli, 41400, Turkey (Türkiye)

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Bristol, Avon, BS10 5NB, United Kingdom

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Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

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London, London, NW3 2QG, United Kingdom

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London, London, SW3 6JJ, United Kingdom

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Greater Manchester, Manchester, M20 4BX, United Kingdom

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Sutton, Surrey, SM2 5PT, United Kingdom

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Leeds, West Yorkshire, LS9 7TF, United Kingdom

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Aberdeen, AB25 2ZN, United Kingdom

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MeSH Terms

Conditions

Carcinoma; Carcinoma, Non-Small-Cell Lung

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: BAYER

clinical-trials-contact@bayerhealthcare.com

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2009
• First Posted: March 18, 2009
• Study Start: April 1, 2009
• Primary Completion: March 1, 2012
• Study Completion: April 1, 2013
• Last Updated: January 19, 2015
• Results First Posted: July 30, 2013

Record last verified: 2015-01

Locations

US (3); HU (6); HK (3); TW (5); BU (5); AR (7); AU (3); JP (8); KR (5); CA (1); TU (5); NL (6); RU (6); TH (3); PH (4); GR (3); GB (8); IT (9); BR (8); IN (3); PL (6); PA (2); FR (8); BE (4); IL (6); ID (2); SG (2); SE (5); CN (12); DE (11); PE (6); ES (10); CL (2); ZA (5)