LDK378 Versus Chemotherapy in Previously Untreated Patients With ALK Rearranged Non-small Cell Lung Cancer
NCT ID: NCT01828099
Last Updated: 2025-01-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
376 participants
INTERVENTIONAL
2013-07-09
2024-01-07
Brief Summary
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Detailed Description
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The patients were randomized in a 1:1 ratio to either receive ceritinib (750 mg once daily, fasted) or chemotherapy. The chemotherapy regimen consisted of a platinum-based doublet with pemetrexed followed by pemetrexed maintenance in patients without progressive disease after 4 cycles.
Treatment was continued until the blinded independent review committee (BIRC) confirmed disease progression based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1), occurrence of unacceptable toxicity, or meeting other discontinuation criteria. Patients in either arm were permitted to continue the assigned study treatment beyond BIRC-confirmed disease progression in case of continued clinical benefit, as determined by the Investigator.
All patients who discontinued treatment during the treatment phase for reasons other than death, lost to follow-up, pregnancy or disease progression entered the post-treatment follow-up period until disease progression, withdrawal of consent or death.
In the chemotherapy arm, patients were allowed to switch and receive ceritinib after BIRC-confirmed disease progression (extension-treatment period).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Ceritinib
Ceritinib administered continuously through oral dosing at a dosage of 750 mg once daily in fasted state.
Ceritinib
Ceritinib was administered orally once-daily fasted at a dose of 750 mg capsules on a continuous dosing schedule.
Chemotherapy
Pemetrexed plus cisplatin or carboplatin (based on Investigator's choice) for 4 cycles (Induction) followed by pemetrexed as single agent (Maintenance)
Pemetrexed
Pemetrexed was administered at a dose of 500 mg/m\^2 as an intravenous (iv) infusion on Day 1 of each 21-day cycle
Cisplatin
Cisplatin was administered by iv infusion at a dose of 75 mg/m\^2 every 21 days for up to 4 cycles.
Carboplatin
Carboplatin was administered as iv infusion (AUC 5-6) every 21 days up to 4 cycles
Interventions
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Ceritinib
Ceritinib was administered orally once-daily fasted at a dose of 750 mg capsules on a continuous dosing schedule.
Pemetrexed
Pemetrexed was administered at a dose of 500 mg/m\^2 as an intravenous (iv) infusion on Day 1 of each 21-day cycle
Cisplatin
Cisplatin was administered by iv infusion at a dose of 75 mg/m\^2 every 21 days for up to 4 cycles.
Carboplatin
Carboplatin was administered as iv infusion (AUC 5-6) every 21 days up to 4 cycles
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. The patient had a newly diagnosed stage IIIB (who was not a candidate for definitive multimodality therapy) or stage IV NSCLC or relapsed locally advanced or metastatic NSCLC not previously treated with any systemic anti-cancer therapy (e.g. cytotoxic drugs, monoclonal antibody therapy, crizotinib or other ALK inhibitors, or other targeted therapies, either experimental or not), with the exception of neo-adjuvant or adjuvant therapy.
3. The patient had at least one measurable lesion as defined by RECIST 1.1.
Exclusion Criteria
2. The patient had a history of severe hypersensitivity reaction to platinum-containing drugs, pemetrexed, or any known excipients of these drugs.
3. The patient had symptomatic central nervous system (CNS) metastases and was neurologically unstable or had required increasing doses of steroids within the 2 weeks prior to screening to manage CNS symptoms.
18 Years
100 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
CABA, Buenos Aires, Argentina
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CABA, Buenos Aires, Argentina
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La Rioja, , Argentina
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Woolloongabba, Queensland, Australia
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Heidelberg, Victoria, Australia
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Auckland, , Australia
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Salzburg, , Austria
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Vienna, , Austria
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Fortaleza, Ceará, Brazil
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Salvador, Estado de Bahia, Brazil
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Recife, Pernambuco, Brazil
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Rio de Janiero, Rio de Janeiro, Brazil
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Natal, Rio Grande do Norte, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Itajaí, Santa Catarina, Brazil
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Barretos, São Paulo, Brazil
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São José do Rio Preto, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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Guangzhou, Guangdong, China
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Changchun, Jilin, China
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Changchun, Jilin, China
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Shanghai, Shanghai Municipality, China
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Xi’an, Shanxi, China
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Chengdu, Sichuan, China
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Hangzhou, Zhejiang, China
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Hangzhou, Zhejiang, China
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Beijing, , China
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Beijing, , China
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Chongqing, , China
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Chongqing, , China
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Guang Dong Province, , China
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Tianjin, , China
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Bogota, Cundinamarca, Colombia
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Montería, , Colombia
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Herlev, , Denmark
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Odense C, , Denmark
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Limoges, Haute Vienne, France
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Toulon, Val De Marne, France
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Caen, , France
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Grenoble, , France
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Lille, , France
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Paris, , France
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Pierre-Bénite, , France
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Rennes, , France
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Strasbourg, , France
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Villejuif, , France
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Cologne, , Germany
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Coswig, , Germany
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Essen, , Germany
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Göttingen, , Germany
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Großhansdorf, , Germany
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Heidelberg, , Germany
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Oldenburg, , Germany
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Tübingen, , Germany
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Ulm, , Germany
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Wiesbaden, , Germany
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Athens, GR, Greece
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Heraklion Crete, , Greece
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Zalaegerszeg, Zala County, Hungary
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Budapest, , Hungary
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Nyíregyháza, , Hungary
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Veszprém, , Hungary
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Hyderabad, Andhra Pradesh, India
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Bangalore, Karnataka, India
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Kochi, Kerala, India
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Nashik, Maharashtra, India
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New Delhi, National Capital Territory of Delhi, India
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Jaipur, Rajasthan, India
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Madurai, Tamil Nadu, India
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Vellore, Tamil Nadu, India
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Kolkata, West Bengal, India
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Delhi, , India
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Mumbai, , India
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Dublin, , Ireland
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Ancona, AN, Italy
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Bergamo, BG, Italy
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Genova, GE, Italy
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Monza, MB, Italy
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Milan, MI, Italy
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Milan, MI, Italy
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Milan, MI, Italy
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Rozzano, MI, Italy
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Perugia, PG, Italy
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Pisa, PI, Italy
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Aviano, PN, Italy
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Parma, PR, Italy
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Reggio Emilia, RE, Italy
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Roma, RM, Italy
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Roma, RM, Italy
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Orbassano, TO, Italy
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Udine, UD, Italy
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Napoli, , Italy
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Nagoya, Aichi-ken, Japan
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Kashiwa, Chiba, Japan
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Akashi, Hyōgo, Japan
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Hirakata, Osaka, Japan
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Osaka, Osaka, Japan
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Koto Ku, Tokyo, Japan
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Niigata, , Japan
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El Achrafiyé, , Lebanon
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Saida, , Lebanon
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Guadalajara, Jalisco, Mexico
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Leiden, South Holland, Netherlands
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Amersfroort, , Netherlands
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Enschede, , Netherlands
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Groningen, , Netherlands
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Groningen, , Netherlands
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Maastricht, , Netherlands
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Zoetermeer, , Netherlands
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Oslo, , Norway
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Szczecin, , Poland
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Warsaw, , Poland
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Moscow, , Russia
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Saint Petersburg, , Russia
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Singapore, , Singapore
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Singapore, , Singapore
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Bundang Gu, Gyeonggi-do, South Korea
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Gyeonggi-do, Korea, South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Granada, Andalusia, Spain
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Málaga, Andalusia, Spain
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Seville, Andalusia, Spain
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Seville, Andalusia, Spain
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Palma de Mallorca, Balearic Islands, Spain
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Barcelona, Catalonia, Spain
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Barcelona, Catalonia, Spain
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L'Hospitalet de Llobregat, Catalonia, Spain
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Lleida, Catalonia, Spain
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Mataró, Catalonia, Spain
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Reus, Catalonia, Spain
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Badajoz, Extremadura, Spain
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A Coruña, Galicia, Spain
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Lugo, Galicia, Spain
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Pamplona, Navarre, Spain
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Oviedo, Principality of Asturias, Spain
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San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain
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Alicante, Valencia, Spain
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Valencia, Valencia, Spain
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Barcelona, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Linköping, , Sweden
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Lund, , Sweden
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Stockholm, , Sweden
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Uppsala, , Sweden
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Kaohsiung City, , Taiwan
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Taichung, , Taiwan
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Taichung, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taoyuan District, , Taiwan
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Songkhla, Hat Yai, Thailand
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Khon Kaen, THA, Thailand
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Bangkok, , Thailand
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Bangkok, , Thailand
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Ankara, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Exeter, Devon, United Kingdom
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Leeds, West Yorkshire, United Kingdom
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Birmingham, , United Kingdom
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London, , United Kingdom
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Manchester, , United Kingdom
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Nottingham, , United Kingdom
Countries
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References
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Soria JC, Tan DSW, Chiari R, Wu YL, Paz-Ares L, Wolf J, Geater SL, Orlov S, Cortinovis D, Yu CJ, Hochmair M, Cortot AB, Tsai CM, Moro-Sibilot D, Campelo RG, McCulloch T, Sen P, Dugan M, Pantano S, Branle F, Massacesi C, de Castro G Jr. First-line ceritinib versus platinum-based chemotherapy in advanced ALK-rearranged non-small-cell lung cancer (ASCEND-4): a randomised, open-label, phase 3 study. Lancet. 2017 Mar 4;389(10072):917-929. doi: 10.1016/S0140-6736(17)30123-X. Epub 2017 Jan 24.
Lin YT, Yu CJ, Yang JC, Shih JY. Anaplastic Lymphoma Kinase (ALK) Kinase Domain Mutation Following ALK Inhibitor(s) Failure in Advanced ALK Positive Non-Small-Cell Lung Cancer: Analysis and Literature Review. Clin Lung Cancer. 2016 Sep;17(5):e77-e94. doi: 10.1016/j.cllc.2016.03.005. Epub 2016 Mar 30.
Other Identifiers
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2013-000319-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CLDK378A2301
Identifier Type: -
Identifier Source: org_study_id
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