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Spots Global Cancer Trial Database for LDK378 Versus Chemotherapy in Previously Untreated Patients With ALK Rearranged Non-small Cell Lung Cancer

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Trial Identification

Brief Title: LDK378 Versus Chemotherapy in Previously Untreated Patients With ALK Rearranged Non-small Cell Lung Cancer

Official Title: A Phase III Multicenter, Randomized Study of Oral LDK378 Versus Standard Chemotherapy in Previously Untreated Adult Patients With ALK Rearranged (ALK-positive), Stage IIIB or IV, Non-squamous Non-small Cell Lung Cancer

Study ID: NCT01828099

Conditions

Non-Small Cell Lung Cancer

Interventions

Study Description

Brief Summary: The primary purpose of the study was to compare the antitumor activity of LDK378 versus reference chemotherapy. Patients in the chemotherapy arm were given the option to switch to LDK378 after confirmed progressive disease (PD), while also had the choice to continue with pemetrexed treatment.

Detailed Description:

Keywords

Non-Small Cell Lung Cancer

NSCLC

ALK

LDK378

Non-small cell lung carcinoma (NSCLC)

treatment of lung cancer after first metastasis

lung cancer

lung adenocarcinoma

Non small cell lung carcinoma

Non small cell lung cancer

non-squamous non-small cell lung cancer

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Novartis Investigative Site, Woolloongabba, Queensland, Australia

Novartis Investigative Site, Heidelberg, Victoria, Australia

Novartis Investigative Site, Auckland, , Australia

Novartis Investigative Site, Salzburg, , Austria

Novartis Investigative Site, Wien, , Austria

Novartis Investigative Site, Porto Alegre, Rio Grande Do Sul, Brazil

Novartis Investigative Site, Natal, RN, Brazil

Novartis Investigative Site, Itajai, SC, Brazil

Novartis Investigative Site, Barretos, SP, Brazil

Novartis Investigative Site, Sao Jose do Rio Preto, SP, Brazil

Novartis Investigative Site, Sao Paulo, SP, Brazil

Novartis Investigative Site, Beijing, Beijing, China

Novartis Investigative Site, Chongqing, Chongqing, China

Novartis Investigative Site, Guangzhou, Guangdong, China

Novartis Investigative Site, Chang Chun, Jilin, China

Novartis Investigative Site, Changchun, Jilin, China

Novartis Investigative Site, Shanghai, Shanghai, China

Novartis Investigative Site, XI An, Shanxi, China

Novartis Investigative Site, Chengdu, Sichuan, China

Novartis Investigative Site, Hangzhou, Zhejiang, China

Novartis Investigative Site, Beijing, , China

Novartis Investigative Site, Chongqing, , China

Novartis Investigative Site, Guang Dong Province, , China

Novartis Investigative Site, Tianjin, , China

Novartis Investigative Site, Monteria, , Colombia

Novartis Investigative Site, Herlev, , Denmark

Novartis Investigative Site, Odense C, , Denmark

Novartis Investigative Site, Toulon Cedex 9, Val De Marne, France

Novartis Investigative Site, Caen, , France

Novartis Investigative Site, Grenoble, , France

Novartis Investigative Site, Lille Cedex, , France

Novartis Investigative Site, Limoges Cedex, , France

Novartis Investigative Site, Paris 10, , France

Novartis Investigative Site, Pierre Benite, , France

Novartis Investigative Site, Rennes, , France

Novartis Investigative Site, Strasbourg Cedex, , France

Novartis Investigative Site, Villejuif, , France

Novartis Investigative Site, Gottingen, , Germany

Novartis Investigative Site, Heidelberg, , Germany

Novartis Investigative Site, Tuebingen, , Germany

Novartis Investigative Site, Ulm, , Germany

Novartis Investigative Site, Wiesbaden, , Germany

Novartis Investigative Site, Heraklion Crete, , Greece

Novartis Investigative Site, Hyderabad, Andhra Pradesh, India

Novartis Investigative Site, Bangalore, Karnataka, India

Novartis Investigative Site, Nashik, Maharashtra, India

Novartis Investigative Site, Jaipur, Rajasthan, India

Novartis Investigative Site, Vellore, Tamil Nadu, India

Novartis Investigative Site, Kolkata, West Bengal, India

Novartis Investigative Site, Delhi, , India

Novartis Investigative Site, Mumbai, , India

Novartis Investigative Site, Dublin 4, , Ireland

Novartis Investigative Site, Ancona, AN, Italy

Novartis Investigative Site, Bergamo, BG, Italy

Novartis Investigative Site, Genova, GE, Italy

Novartis Investigative Site, Monza, MB, Italy

Novartis Investigative Site, Milano, MI, Italy

Novartis Investigative Site, Rozzano, MI, Italy

Novartis Investigative Site, Perugia, PG, Italy

Novartis Investigative Site, Pisa, PI, Italy

Novartis Investigative Site, Aviano, PN, Italy

Novartis Investigative Site, Parma, PR, Italy

Novartis Investigative Site, Reggio Emilia, RE, Italy

Novartis Investigative Site, Roma, RM, Italy

Novartis Investigative Site, Orbassano, TO, Italy

Novartis Investigative Site, Udine, UD, Italy

Novartis Investigative Site, Napoli, , Italy

Novartis Investigative Site, Nagoya, Aichi, Japan

Novartis Investigative Site, Kashiwa, Chiba, Japan

Novartis Investigative Site, Akashi, Hyogo, Japan

Novartis Investigative Site, Hirakata-city, Osaka, Japan

Novartis Investigative Site, Osaka-city, Osaka, Japan

Novartis Investigative Site, Koto ku, Tokyo, Japan

Novartis Investigative Site, Niigata, , Japan

Novartis Investigative Site, Bundang Gu, Gyeonggi Do, Korea, Republic of

Novartis Investigative Site, Seoul, Korea, Korea, Republic of

Novartis Investigative Site, Seoul, , Korea, Republic of

Novartis Investigative Site, Ashrafieh, , Lebanon

Novartis Investigative Site, Saida, , Lebanon

Novartis Investigative Site, Guadalajara, Jalisco, Mexico

Novartis Investigative Site, Maastricht, AZ, Netherlands

Novartis Investigative Site, Amsterdam, , Netherlands

Novartis Investigative Site, Breda, , Netherlands

Novartis Investigative Site, Groningen, , Netherlands

Novartis Investigative Site, Leiden, , Netherlands

Novartis Investigative Site, Oslo, , Norway

Novartis Investigative Site, Szczecin, , Poland

Novartis Investigative Site, Warszawa, , Poland

Novartis Investigative Site, Moscow, , Russian Federation

Novartis Investigative Site, Saint Petersburg, , Russian Federation

Novartis Investigative Site, Singapore, , Singapore

Novartis Investigative Site, Granada, Andalucia, Spain

Novartis Investigative Site, Sevilla, Andalucia, Spain

Novartis Investigative Site, Oviedo, Asturias, Spain

Novartis Investigative Site, Barcelona, Catalunya, Spain

Novartis Investigative Site, Hospitalet de LLobregat, Catalunya, Spain

Novartis Investigative Site, Badajoz, Extremadura, Spain

Novartis Investigative Site, La Coruna, Galicia, Spain

Novartis Investigative Site, Reus, Tarragona, Spain

Novartis Investigative Site, Barcelona, , Spain

Novartis Investigative Site, Madrid, , Spain

Novartis Investigative Site, Linkoping, , Sweden

Novartis Investigative Site, Lund, , Sweden

Novartis Investigative Site, Stockholm, , Sweden

Novartis Investigative Site, Uppsala, , Sweden

Novartis Investigative Site, Taipei, Taiwan, ROC, Taiwan

Novartis Investigative Site, Kuei Shan Chiang, Taoyuan, Taiwan

Novartis Investigative Site, Kaohsiung, , Taiwan

Novartis Investigative Site, Taichung City, , Taiwan

Novartis Investigative Site, Taichung, , Taiwan

Novartis Investigative Site, Taipei, , Taiwan

Novartis Investigative Site, Songkhla, Hat Yai, Thailand

Novartis Investigative Site, Khon Kaen, THA, Thailand

Novartis Investigative Site, Bangkok, , Thailand

Novartis Investigative Site, Ankara, Sihhiye, Turkey

Novartis Investigative Site, Istanbul, , Turkey

Novartis Investigative Site, Leeds, West Yorkshire, United Kingdom

Novartis Investigative Site, Birmingham, , United Kingdom

Novartis Investigative Site, London, , United Kingdom

Novartis Investigative Site, Manchester, , United Kingdom

Contact Details

Name: Novartis Pharmaceuticals

Affiliation: Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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