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

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

ClinicalTrials.gov Identifier: NCT01828099

Novartis Reference Number: CLDK378A2301

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

The primary purpose of the study was to compare the antitumor activity of LDK378 versus reference chemotherapy. Patients in the chemotherapy arm were allowed to cross-over to LDK378 after confirmed progressive disease (PD).

Condition 
Non-Small Cell Lung Cancer
Phase 
Phase 3
Overall status 
Active, not recruiting
Enrollment count 
376 participants
Start date 
Mar 13, 2013
Completion date 
Sep 11, 2023
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
Ceritinib
Ceritinib was administered orally once-daily fasted at a dose of 750 mg capsules on a continuous dosing schedule. Ceritinib (LDK378) was the investigational treatment and is referred to as the investigational study treatment/drug.
Drug
Pemetrexed
Pemetrexed was administered at a dose of 500 mg/m2 as an iv infusion on Day 1 of each 21-day cycle to patients randomized to the chemotherapy arm.
Drug
Cisplatin
Cisplatin was administered by IV at a dose of 75 mg/m2 every 21 days for up to 4 cycles.
Drug
Carboplatin
Carboplatin was administered as iv infusion (AUC 5-6) every 21 days up to 4 cycles

Eligibility Criteria

Inclusion Criteria:

Patient has a histologically or cytologically confirmed diagnosis of non-squamous Non-small cell lung cancer (NSCLC) that is Anaplastic lymphoma kinase (ALK) positive as assessed by the Ventana Immunohistochemistry (IHC) test. The test will be performed at Novartis designated central laboratories.
Patient has newly diagnosed stage IIIB (who are 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 exception of neo-adjuvant or adjuvant therapy
Patient has at least one measurable lesion as defined by RECIST 1.1.

Exclusion Criteria:

Patient with known hypersensitivity to any of the excipients of LDK378 (microcrystalline cellulose, mannitol, crospovidone, colloidal silicon dioxide and magnesium stearate)
Patient with a history of severe hypersensitivity reaction to platinum containing drugs, pemetrexed or any known excipients of these drugs.
Patient with symptomatic central nervous system (CNS) metastases who is neurologically unstable or has required increasing doses of steroids within the 2 weeks prior to screening to manage CNS symptoms.

Study Locations

Australia
Novartis Investigative Site
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Woolloongabba, 4102
Queensland
Australia
Novartis Investigative Site
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Heidelberg, 3084
Victoria
Australia
Novartis Investigative Site
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Auckland, 92024
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Australia
Austria
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Salzburg, 5020
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Austria
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Wien, 1210
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Austria
Brazil
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Porto Alegre, 90610-000
Rio Grande Do Sul
Brazil
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Natal, 59075 740
RN
Brazil
Novartis Investigative Site
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Itajai, 88301-229
SC
Brazil
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Barretos, 14784 400
SP
Brazil
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Sao Jose do Rio Preto, 15090 000
SP
Brazil
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Sao Paulo, 01246-000
SP
Brazil
China
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Beijing, 100730
Beijing
China
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Chongqing, 400037
Chongqing
China
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Guangzhou, 51000
Guangdong
China
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Chang Chun, 130021
Jilin
China
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Changchun, 130012
Jilin
China
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Shanghai, 200433
Shanghai
China
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Xi'an, 710038
Shanxi
China
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Chengdu, 610041
Sichuan
China
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Hangzhou, 310003
Zhejiang
China
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Hangzhou, 310022
Zhejiang
China
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Beijing, 101149
-
China
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Chongqing, 400042
-
China
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Guang Dong Province, 510120
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China
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Tianjin, 300052
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China
Colombia
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Monteria,
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Colombia
Denmark
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Herlev, DK 2730
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Denmark
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Odense C, DK 5000
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Denmark
France
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Toulon Cedex 9, 83800
Val De Marne
France
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Caen, 14033
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France
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Grenoble, 38043
-
France
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LILLE Cédex, 59037
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France
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Limoges Cedex, 87042
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France
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Paris, 75010
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France
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Pierre Benite, 69495
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France
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Rennes, 35043
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France
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Strasbourg Cedex, 67091
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France
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Villejuif Cedex, 94800
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France
Germany
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Gottingen, 37075
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Germany
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Heidelberg, 69120
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Germany
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Tübingen, 72076
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Germany
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Ulm, 89081
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Germany
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Wiesbaden, D-65199
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Germany
Greece
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Heraklion Crete, 711 10
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Greece
India
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Hyderabad, 500 034
Andhra Pradesh
India
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Bangalore, 560 095
Karnataka
India
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Nashik, 422 004
Maharashtra
India
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Jaipur, 302017
Rajasthan
India
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Vellore, 632 004
Tamil Nadu
India
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Kolkata, 700160
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India
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Delhi, 110 085
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India
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Mumbai, 400 012
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Dublin 4,
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Milano, 20162
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Rozzano, 20089
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Perugia, 06129
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Pisa, 56124
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Aviano, 33081
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Parma, 43100
PR
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Reggio Emilia, 42123
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Roma, 00152
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Roma, 00189
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Orbassano, 10043
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Udine, 33100
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Napoli, 80131
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Nagoya, 464 8681
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Kashiwa, 277 8577
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Akashi, 673-8558
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Hirakata-city, 573-1191
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Osaka-city, 541-8567
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Japan
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Koto ku, 135 8550
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Niigata, 951 8520
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Japan
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Bundang Gu, 13620
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Seoul, 05505
Korea
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Seoul, 03722
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Seoul, 06351
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Lebanon
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Ashrafieh, 166830
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Guadalajara, 44280
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Maastricht, 5800
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Amsterdam, 1081 HV
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Breda, 4819 EV
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Netherlands
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Groningen, 9728 NT
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Leiden, 2300 RC
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Oslo, NO-0424
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Norway
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Szczecin, 70-891
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Warszawa, 02 781
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Porto, 4099-001
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Moscow, 115478
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Saint Petersburg, 197022
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Russian Federation
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Singapore
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Singapore, 169610
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Granada, 18014
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Sevilla, 41014
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Oviedo, 33006
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Barcelona, 08003
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Barcelona, 08035
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Hospitalet de LLobregat, 08907
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Badajoz, 06080
Extremadura
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La Coruna, 15006
Galicia
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Reus, 43201
Tarragona
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Barcelona, 08041
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Spain
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Madrid, 28033
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Spain
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Madrid, 28040
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Spain
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Madrid, 28041
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Spain
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Madrid, 28050
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Spain
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Linkoping, SE 581 85
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Sweden
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Lund, SE-221 85
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Sweden
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Stockholm, 171 76
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Sweden
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Uppsala, 751 85
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Sweden
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Taipei, 11217
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Taiwan
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Kuei-Shan Chiang, 33305
Taoyuan/ Taiwan ROC
Taiwan
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Kaohsiung City, 83301
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Taichung City, 407
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Taichung, 40447
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Taipei, 10048
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Taiwan
Thailand
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Songkhla, 90110
Hat Yai
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Khon Kaen, 40002
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Thailand
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Bangkok, 10330
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Thailand
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Bangkok, 10400
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Thailand
Turkey
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Ankara, 06100
Sihhiye
Turkey
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Istanbul, 34303
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Turkey
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Leeds, LS9 7TF
West Yorkshire
United Kingdom
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Birmingham, B9 5SS
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United Kingdom
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London, NW1 2PJ
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Manchester, M20 2BX
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United Kingdom

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