Trial Condition(s):
Carcinoma, Non-Small-Cell Lung
A Phase III Randomized, Double-blind, Placebo Controlled Trial Comparing the Efficacy of Gemcitabine, Cisplatin and Sorafenib to Gemcitabine, Cisplatin and Placebo in First-Line Treatment of Patients with Stage IIIb with Effusion and Stage IV Non-Small Cell Lung Cancer (NSCLC) (NEXUS)
Bayer Identifier:
12006
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
Evaluation of gemcitabine and cisplatin in combination with either sorafenib or placebo for the treatment of patients with advanced Non-Small Cell Lung Cancer (NSCLC)
Inclusion Criteria
- Age > 18 years old - Stage IIIB (with cytologically confirmed malignant pleural or pericardial effusion) or Stage IV histological or cytological confirmation of NSCLC of non-squamous cell carcinoma subtype. (thoracentesis or pericardiocentesis is not necessary if a biopsy of the original tumor is available to confirm diagnosis of NSCLC). - Patients with at least one measurable lesion. Lesions must be measured by CT-scan or MRI (Magnetic resonance imaging) according to Response Evaluation Criteria in Solid Tumors (RECIST, see Appendix 10.3) - Life expectancy of at least 12 weeks - Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to start of first dose: - Hemoglobin >/= 9.0 g/dl (>/= 5.6 mmol/l) - Absolute neutrophil count (ANC) >/= 1,500/mm3 - Platelet count >/= 100,000/µl - Total bilirubin </= 1.5 x upper limit of normal - Alanine transaminase (ALT) and Aspartate transaminase (AST) </= 2.5 x upper limit of normal (</= 5 x upper limit of normal for patients with liver involvement of their cancer) - Alkaline Phosphatase </= 4 x upper limit of normal - PT-INR (Prothrombin Time - International Normalized Ratio) (international normalized ratio of PT) /PTT (Partial Thromboplastin Time) < 1.5 x upper limit of normal - Serum Creatinine </= 1.5 times the upper limit of normal and Serum Creatinine Clearance >/= 70ml/min - Ability to understand and the willingness to sign a written informed consent. A signed informed consent must be obtained prior to performing any study specific procedures. - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
Exclusion Criteria
- Excluded medical conditions: -- Cardiac disease: Congestive heart failure > class II NYHA (New York Heart Association). Patients must not have unstable angina (anginal symptoms at rest) or active coronary artery disease (CAD), or myocardial infarction within the past 6 months -- Cardiac arrhythmias requiring anti-arrhythmic therapy -- Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management. -- History of HIV (Human immunodeficiency virus) infection or chronic hepatitis B or C -- Active clinically serious infections (> grade 2 NCI-CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) version 3.0) -- Patients with seizure disorder requiring medication (such as steroids or anti-epileptics) -- Known brain metastasis. Patients with neurological symptoms should undergo a CT scan/MRI of the brain to exclude brain metastasis. -- History of organ allograft -- Patients with evidence or history of bleeding diathesis or coagulopathy -- Patients undergoing renal dialysis -- Cancer other than NSCLC within 5 years prior to start of study treatment EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, or superficial bladder tumors [Ta (Noninvasive tumor), Tis (Carcinoma in situ) & T1 (Tumor invades lamina propria)] -- Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management. -- Thrombotic or embolic events such as cerebrovascular accident including transient ischemic attacks within the past 6 months -- Pulmonary hemorrhage/bleeding event > Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 within 4 weeks of first dose of study drug -- Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first dose of study drug -- Serious, non-healing wound, ulcer, or bone fracture -- Uncorrected dehydration -- Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. Both men and women enrolled in this trial must use adequate birth control measures during the course of the trial. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate. -- Substance abuse, medical, psychological or social conditions that may interfere with the patient’s participation in the study or evaluation of the study results -- Known or suspected allergy to the investigational agent or any agent given in association with this trial -- Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study -- Patients unable to swallow oral medications -- Any malabsorption condition -- Patients with a hearing impairment (FOR GERMANY ONLY) -- NSCLC patients with squamous cell carcinoma diagnosis documented either by cytology or biopsy. - Excluded therapies and medications, previous and concomitant: -- Any prior systemic anticancer therapy including cytotoxic therapy, targeted agents, experimental therapy, adjuvant, or neo-adjuvant therapy for NSCLC -- Concomitant use of nephrotoxic drugs, ototoxic drugs, anticonvulsant, anti-gout treatment -- Radiotherapy during study or within 3 weeks of start of study drug. (Palliative radiotherapy will be allowed as described in the Prior and Concomitant Therapy section) -- Radiotherapy during study or within 4 weeks of start of study drug. (Palliative radiotherapy will be allowed as described in the Prior and Concomitant Therapy section) (FOR FRANCE ONLY) -- Major surgery, open biopsy or significant traumatic injury within 4 weeks of first dose of study drug (bronchoscopy is allowed) -- Granulocyte colony stimulating factor (GCSF) or Granulocyte macrophage colony stimulating factor (GMCSF), within 3 weeks of study entry (these growth factors may be used during the study thereafter).
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
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Locations Asklepios Fachkliniken München Gauting Gauting, Germany, 82131 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Thoraxklinik-Heidelberg gGmbH Heidelberg, Germany, 69126 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinik Löwenstein gGmbH Löwenstein, Germany, 74245 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kliniken der Stadt Köln - Städt. Krankenhaus Köln-Merheim Köln, Germany, 51109 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations St. Vincentius-Kliniken gAG Karlsruhe, Germany, 76137 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinikum Essen Essen, Germany, 45122 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Asklepios Klinik Harburg Hamburg, Germany, 21075 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Krankenhaus Hofheim am Taunus Hofheim , Germany, 65719 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Addenbrookes Hospital Cambridge, United Kingdom, CB2 0QQ | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations New Cross Hospital Wolverhampton, United Kingdom, WV10 0QP | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre René Gauducheau - Nantes NANTES, France, 44805 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinique Sainte Marguerite - Hyères HYERES, France, 83400 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hôpital Sainte Marguerite - Marseille MARSEILLE, France, 13275 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Krankenhaus Grosshansdorf Großhansdorf, Germany, 22927 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations St. Markus-Krankenhaus Frankfurt, Germany, 60431 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Zentralklinik Bad Berka GmbH Bad Berka, Germany, 99437 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Städtisches Klinikum "St. Georg" Leipzig Leipzig, Germany, 04207 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Aberdeen Royal Infirmary Aberdeen, United Kingdom, AB25 2ZN | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Guy's Hospital London, United Kingdom, SE1 9RT | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Leicester Royal Infirmary Leicester, United Kingdom, LE1 5WW | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Royal Marsden NHS Trust (Surrey) Sutton, United Kingdom, SM2 5PT | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Queen Elizabeth Hospital Birmingham, United Kingdom, B15 2TH | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Royal Marsden Hospital (London) London, United Kingdom, SW3 6JJ | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre Hospitalier Lyon Sud - Pierre Bénite PIERRE BENITE, France, 69495 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre Hospitalier Universitaire - Grenoble GRENOBLE, France, 38043 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hôpital Bretonneau - Tours TOURS, France, 37044 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Nouvel Hopital CIVIL-CHU Strasbourg Strasbourg, France, 67901 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations IRCCS Istituto Clinico Humanitas Rozzano, Italy, 20089 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations ARNAS Garibaldi Catania, Italy, 95122 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. di Bologna Bologna, Italy, 40138 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations IRCCS Fondazione San Raffaele Milano, Italy, 20132 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Universitario 12 de Octubre Madrid, Spain, 28041 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital de la Santa Creu i de Sant Pau Barcelona, Spain, 08025 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Arnau de Vilanova de Valencia Valencia, Spain, 46015 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Universitario Virgen del Rocío Sevilla, Spain, 41013 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Complejo Hospitalario Universitario A Coruña A Coruña, Spain, 15006 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations UZ Leuven Gasthuisberg LEUVEN, Belgium, 3000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations AZ Klina BRASSCHAAT, Belgium, 2930 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinique Sainte-Elisabeth NAMUR, Belgium, 5000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations CHU de Liège LIEGE, Belgium, 4000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Jeroen Bosch Ziekenhuis DEN BOSCH, Netherlands, 5211 RW | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hopital Européen Georges Pompidou - Paris PARIS CEDEX 15, France, 75908 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinique du Mail - Grenoble GRENOBLE, France, 38100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre de Radiologie Oncologie Médicale - Nimes NIMES CEDEX 2, France, 30907 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinique Victor Hugo - Le Mans LE MANS CEDEX 2, France, 72015 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre Catalan d'Oncologie PERPIGNAN, France, 66000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinique Paulmy - Bayonne BAYONNE, France, 64100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. San Camillo-Forlanini Roma, Italy, 00152 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations AUSL 06 Livorno - Toscana Livorno, Italy, 57124 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Integrata Verona Verona, Italy, 37134 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations ASL Sassari - Sardegna Sassari, Italy, 07100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Careggi Firenze, Italy, 50134 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations AULSS 12 Veneziana - Veneto Venezia, Italy, 30122 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. San Gerardo di Monza Monza, Italy, 20052 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations IRCCS Centro di Riferimento Oncologico - CRO Aviano, Italy, 33081 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital General Universitario de Valencia Valencia, Spain, 46014 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Consorci Sanitari de Terrassa Terrassa, Spain, 08227 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ziekenhuis Gelderse Vallei Ede, Netherlands, 6716 RP | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Atrium Medisch Centrum Parkstad HEERLEN, Netherlands, 6419 PC | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde" Guadalajara, Mexico, 44280 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Universitario "José Eleuterio González" Monterrey, Mexico, 64460 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Instituto Nacional de Cancerología México, Mexico, 14080 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinikum Innsbruck Innsbruck, Austria, 6020 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Krankenhaus Hietzing Wien, Austria, 1130 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations SMZ Baumgartner Höhe Otto Wagner Spital Wien, Austria, 1140 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Orszagos Koranyi TBC es Pulmonologiai Intezet Budapest, Hungary, 1121 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Fovarosi Onkormanyzat Szent Janos Korhaza es Eszak-Budai Budapest, Hungary, 1125 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sotiria General State Hospital of Chest Diseases Athens, Greece, 11527 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sotiria General State Hospital of Chest Diseases Athens, Greece, 11527 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Santa Casa de Misericórdia da Bahia Hospital Santa Izabel Salvador, Brazil, 40050410 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Lifecenter Belo Horizonte, Brazil, 30110-090 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Virgen de la Victoria Málaga, Spain, 29010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Regional Carlos Haya Málaga, Spain, 29010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital de Cruces Cruces/Barakaldo, Spain, 48903 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Clínico Universitario de Valencia Valencia, Spain, 46010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Clínico Universitario San Carlos Madrid, Spain, 28040 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Royal Victoria Hospital Montreal, Canada, H3A 1A1 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations UZ Antwerpen EDEGEM, Belgium, 2650 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations CU Saint-Luc/UZ St-Luc BRUXELLES - BRUSSEL, Belgium, 1200 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ziekenhuis St. Jansdal HARDERWIJK, Netherlands, 3844 DG | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations St. Antonius Ziekenhuis NIEUWEGEIN, Netherlands, 3435 CM | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Meir Medical Center Kfar Saba, Israel, 4428164 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Chaim Sheba Medical Center Tel Hashomer, Israel, 5262000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kaplan Medical Center Rehovot, Israel, 7610001 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Barzilai Medical Center Ashkelon, Israel, 7830604 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Edith Wolfson Medical Center Holon, Israel, 58100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Amaral Carvalho Jaú, Brazil, 17210-120 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Universitário de Brasília Brasília, Brazil, 70840 901 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Instituto Nacional do Cancer Rio de Janeiro, Brazil, 20231 050 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Santo Andre Diagnostico e Terapeutica Santo Andre, Brazil, 09090-780 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Israelita Albert Einstein São Paulo, Brazil, 05651-901 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centro Goiano de Oncologia Goiânia, Brazil, 74075040 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Oncovida/Centro Médico Iguatemi Salvador, Brazil, 41820 021 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital das Clínicas da Faculdade de Medicina da USP São Paulo, Brazil, 05403-010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Shanghai Chest Hospital, Shanghai Jiaotong University Shanghai, China, 200030 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Cancer Hospital, Chinese Academy of Medical Sciences Beijing, China, 100021 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tongji Hosp. of Huazhong Univ. of Science & Technology Wuhan, China, 430030 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Shanghai Pulmonary Hospital, Tongji University Shanghai, China, 200433 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsspital Basel Basel, Switzerland, 4031 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hôpital Cantonal Universitaire de Genève Genéve, Switzerland, 1205 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Krankenhaus der Elisabethinen Linz Linz, Austria, 4010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Csongrad Megyei Onkormanyzat Mellkasi Betegsegek Szakkorhaza Deszk, Hungary, 6772 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Matrai State Hospital Matrahaza, Hungary, 3233 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Fejer megyei Szent Gyorgy Korhaz Szekesfehervar , Hungary, 8000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Pest County Lung Institute Torokbalint, Hungary, 2045 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University General Hospital of Heraklion Heraklion, Greece, 711 10 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Faculdade de Medicina do ABC Santo André, Brazil, 09060-870 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Sao Lucas da Pontificia Universidade Catolica do RS Porto Alegre, Brazil, 90610-000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Irmandade da Santa Casa de Misericordia - Sao Paulo São Paulo, Brazil, 01221020 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Irmandade Santa Casa de Misericordia de Porto Alegre Porto Alegre, Brazil, 90050 170 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Conjunto Hospitalar de Sorocaba Sorocaba, Brazil, 18030-510 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Office of Dr. Agnaldo Anelli São Paulo, Brazil, 01331020 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Nucleo de Oncologia de Salvador Salvador, Brazil, 40170-070 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hosp. Araujo Jorge da Associação de Combate ao Câncer Goiania, Brazil, 74605-070 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tampereen yliopistollinen sairaala, keskussairaala Tampere, Finland, FIN-33521 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations TYKS/Paimion Sairaala Preitilä, Finland, 21540 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sun Yat-sen University Cancer Center Guangzhou, China, 510060 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations PLA 81 Hospital Nanjing, China, 210002 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sir Run Run Shaw Hospital Hangzhou, China, 310016 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Zhejiang Cancer Hospital Hangzhou, China, 310022 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Inselspital Bern Bern, Switzerland, 3010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations HUS, Meilahden sairaala HUS, Finland, 00029 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Bank of Cyprus Oncology Centre Nicosia, Cyprus, 2006 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
A Phase III Randomized, Double-blind, Placebo Controlled Trial Comparing the Efficacy of Gemcitabine, Cisplatin and Sorafenib to Gemcitabine, Cisplatin and Placebo in First-Line Treatment of Patients with Stage IIIb with effusion and Stage IV Non-Small Cell Lung Cancer (NSCLC)
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Overall Survival (OS) in the ITT (non-squamous) populationTimeframe: from randomization of the first patient until 38 months or date of death of any cause whichever came first
Secondary Outcome
- OS in the ITT (both squamous and non-squamous) populationTimeframe: from randomization of the first patient until 38 months or date of death of any cause whichever came first
- OS in the ITT (squamous) populationTimeframe: from randomization of the first patient until 38 months or date of death of any cause whichever came first
- Progression-free Survival (PFS) in the ITT (non-squamous) populationTimeframe: from randomization of the first patient until 38 months or date of death or progession whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks
- Time to progression (TTP) in the ITT (non-squamous) populationTimeframe: from randomization of the first patient until 38 months or date of death or progession whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks
- Percentage of participants with different Tumor Response in the ITT (non-squamous) populationTimeframe: from randomization of the first patient until 38 months or date of death or progession whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks
- Disease Control (DC) in the ITT (non-squamous) populationTimeframe: from randomization of the first patient until 38 months or date of death or progession whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks
- Duration of Response in the ITT (non-squamous) populationTimeframe: from randomization of the first patient until 38 months or date of death or progession whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks
- Duration of Stable Disease (SD) in the ITT (non-squamous) populationTimeframe: from randomization of the first patient until 38 months or date of death or progession whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks
- Time to Response (TTR) in the ITT (non-squamous) populationTimeframe: from randomization of the first patient until 38 months or date of death of any cause whichever came first
- Functional Assessment of Cancer Treatment-Lung (FACT-L) scores in the ITT (non-squamous) populationTimeframe: from randomization of the first patient until 38 months
- Lung Cancer subscale (LCS) scores in the ITT (non-squamous) populationTimeframe: from randomization of the first patient to 38 months later or death whatever occurs first.
- Time to symptomatic deterioration (TSD) in the ITT (non-squamous) populationTimeframe: from randomization of the first patient to 38 months later or death whatever occurs first
- Euro quality of life - 5D (EQ-5D) index scores in the ITT (non-squamous) populationTimeframe: from randomization of the first patient until 38 months later or death whatever occurs first
- EQ-5D visual analog scale (VAS) scores in the ITT (non-squamous) populationTimeframe: from randomization of the first patient until 38 months later or death whatever occurs first
Additional Information
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