Register a trial

This is a test website


Please note the ANZCTR will be unattended on Monday the 27th of January due to the national public holiday.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01828099




Registration number
NCT01828099
Ethics application status
Date submitted
3/04/2013
Date registered
10/04/2013

Titles & IDs
Public title
LDK378 Versus Chemotherapy in Previously Untreated Patients With ALK Rearranged Non-small Cell Lung Cancer
Scientific 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
Secondary ID [1] 0 0
2013-000319-26
Secondary ID [2] 0 0
CLDK378A2301
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ceritinib
Treatment: Drugs - Pemetrexed
Treatment: Drugs - Cisplatin
Treatment: Drugs - Carboplatin

Experimental: Ceritinib - Ceritinib administered continuously through oral dosing at a dosage of 750 mg once daily in fasted state.

Active comparator: Chemotherapy - Pemetrexed plus cisplatin or carboplatin (based on Investigator's choice) for 4 cycles (Induction) followed by pemetrexed as single agent (Maintenance)


Treatment: Drugs: Ceritinib
Ceritinib was administered orally once-daily fasted at a dose of 750 mg capsules on a continuous dosing schedule.

Treatment: Drugs: 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

Treatment: Drugs: Cisplatin
Cisplatin was administered by iv infusion at a dose of 75 mg/m\^2 every 21 days for up to 4 cycles.

Treatment: Drugs: Carboplatin
Carboplatin was administered as iv infusion (AUC 5-6) every 21 days up to 4 cycles
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS) by Blinded Independent Review Committee (BIRC)
Timepoint [1] 0 0
From the date of randomization to the date of first radiologically documented disease progression or death due to any cause, up to approximately 34 months
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
From date of randomization to date of death due to any cause, up to approximately 120 months
Secondary outcome [2] 0 0
Overall Response Rate (ORR) by BIRC Assessment
Timepoint [2] 0 0
Up to approximately 34 months
Secondary outcome [3] 0 0
Overall Response Rate (ORR) by Investigator Assessment
Timepoint [3] 0 0
Up to approximately 120 months
Secondary outcome [4] 0 0
Duration of Response (DOR) by BIRC Assessment
Timepoint [4] 0 0
From first documented response to first documented disease progression or death, assessed up to approximately 34 months
Secondary outcome [5] 0 0
Duration of Response (DOR) by Investigator Assessment
Timepoint [5] 0 0
From first documented response to first documented disease progression or death, assessed up to approximately 120 months
Secondary outcome [6] 0 0
Disease Control Rate (DCR) by BIRC Assessment
Timepoint [6] 0 0
Up to approximately 34 months
Secondary outcome [7] 0 0
Disease Control Rate (DCR) by Investigator Assessment
Timepoint [7] 0 0
Up to approximately 120 months
Secondary outcome [8] 0 0
Time to Response (TTR) by BIRC Assessment
Timepoint [8] 0 0
From randomization to date of first documented response, up to approximately 34 months
Secondary outcome [9] 0 0
Time to Response (TTR) by Investigator Assessment
Timepoint [9] 0 0
From randomization to date of first documented response, up to approximately 120 months
Secondary outcome [10] 0 0
PFS by Investigator Assessment
Timepoint [10] 0 0
From the date of randomization to the date of first radiologically documented disease progression or death due to any cause, up to approximately 120 months
Secondary outcome [11] 0 0
Overall Intracranial Response Rate (OIRR)
Timepoint [11] 0 0
Up to approximately 34 months
Secondary outcome [12] 0 0
Intracranial Disease Control Rate (IDCR)
Timepoint [12] 0 0
Up to approximately 34 months
Secondary outcome [13] 0 0
Duration of Intracranial Response (DOIR)
Timepoint [13] 0 0
From first documented response to first documented disease progression in the brain or death, assessed up to approximately 34 months
Secondary outcome [14] 0 0
Time to Definitive 10 Point Deterioration in the Composite Endpoint of Pain, Cough or Dyspnea in the European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ)- Lung Cancer (LC) 13 Questionnaire
Timepoint [14] 0 0
Screening, treatment phase (Cycles 2, 3 then every 2nd cycle until Month 33; after Month 33, every 9 or 12 weeks, end of treatment); follow-up phase (Every 6 weeks until Month 33; after Month 33 every 9 or 12 weeks) up to approximately 120 months
Secondary outcome [15] 0 0
Time to Definitive Deterioration in the Composite Endpoint of Pain, Cough or Dyspnea in the Lung Cancer Symptom Scale (LCSS)
Timepoint [15] 0 0
Screening, treatment phase (Cycles 2, 3 then every 2nd cycle until Month 33; after Month 33, every 9 or 12 weeks, end of treatment); follow-up phase (Every 6 weeks until Month 33; after Month 33 every 9 or 12 weeks) up to approximately 120 months
Secondary outcome [16] 0 0
Least Squares Mean Scores on the EORTC-QLQ C30
Timepoint [16] 0 0
Screening, treatment phase (Cycles 2, 3 then every 2nd cycle until Month 33; after Month 33, every 9 or 12 weeks, end of treatment); follow-up phase (Every 6 weeks until Month 33; after Month 33 every 9 or 12 weeks) up to approximately 120 months
Secondary outcome [17] 0 0
Least Squares Mean Scores on the EORTC QLQ- LC13
Timepoint [17] 0 0
Screening, treatment phase (Cycles 2, 3 then every 2nd cycle until Month 33; after Month 33, every 9 or 12 weeks, end of treatment); follow-up phase (Every 6 weeks until Month 33; after Month 33 every 9 or 12 weeks) up to approximately 120 months
Secondary outcome [18] 0 0
Least Squares Mean Scores on the Lung Cancer Symptom Scale (LCSS)
Timepoint [18] 0 0
Screening, treatment phase (Cycles 2, 3 then every 2nd cycle until Month 33; after Month 33, every 9 or 12 weeks, end of treatment); follow-up phase (Every 6 weeks until Month 33; after Month 33 every 9 or 12 weeks) up to approximately 120 months
Secondary outcome [19] 0 0
Least Squares Mean Scores on the EQ-5D-5L Index
Timepoint [19] 0 0
Screening, treatment phase (Cycles 2, 3 then every 2nd cycle until Month 33; after Month 33, every 9 or 12 weeks, end of treatment); follow-up phase (Every 6 weeks until Month 33; after Month 33 every 9 or 12 weeks) up to approximately 120 months
Secondary outcome [20] 0 0
Least Squares Mean Scores on the EQ-5D-5L Visual Analogue Score (VAS)
Timepoint [20] 0 0
Screening, treatment phase (Cycles 2, 3 then every 2nd cycle until Month 33; after Month 33, every 9 or 12 weeks, end of treatment); follow-up phase (Every 6 weeks until Month 33; after Month 33 every 9 or 12 weeks) up to approximately 120 months
Secondary outcome [21] 0 0
Cmax of LDK378
Timepoint [21] 0 0
Cycle 1 Day 1 and Cycle 2 Day 1 at pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose. Cycle=21 days
Secondary outcome [22] 0 0
Tmax of LDK378
Timepoint [22] 0 0
Cycle 1 Day 1 and Cycle 2 Day 1 at pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose. Cycle=21 days
Secondary outcome [23] 0 0
Tlast of LDK378
Timepoint [23] 0 0
Cycle 1 Day 1 and Cycle 2 Day 1 at pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose. Cycle=21 days
Secondary outcome [24] 0 0
AUC0-24 of LDK378
Timepoint [24] 0 0
Cycle 1 Day 1 and Cycle 2 Day 1 at pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose. Cycle=21 days

Eligibility
Key inclusion criteria
Key

1. The patient had a histologically or cytologically confirmed diagnosis of non-squamous Non-small cell lung cancer (NSCLC) that was Anaplastic lymphoma kinase (ALK) positive as assessed by the Ventana Immunohistochemistry (IHC) test. The test was performed at Novartis designated central laboratories.
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.

Key
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. The patient had known hypersensitivity to any of the excipients of LDK378 (microcrystalline cellulose, mannitol, crospovidone, colloidal silicon dioxide, and magnesium stearate).
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/07/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
7/01/2024
Sample size
Target
Accrual to date
Final
376
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Woolloongabba
Recruitment hospital [2] 0 0
Novartis Investigative Site - Heidelberg
Recruitment hospital [3] 0 0
Novartis Investigative Site - Auckland
Recruitment postcode(s) [1] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [2] 0 0
3084 - Heidelberg
Recruitment postcode(s) [3] 0 0
92024 - Auckland
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Argentina
State/province [2] 0 0
La Rioja
Country [3] 0 0
Austria
State/province [3] 0 0
Salzburg
Country [4] 0 0
Austria
State/province [4] 0 0
Wien
Country [5] 0 0
Brazil
State/province [5] 0 0
BA
Country [6] 0 0
Brazil
State/province [6] 0 0
CE
Country [7] 0 0
Brazil
State/province [7] 0 0
PE
Country [8] 0 0
Brazil
State/province [8] 0 0
Rio Grande Do Sul
Country [9] 0 0
Brazil
State/province [9] 0 0
RJ
Country [10] 0 0
Brazil
State/province [10] 0 0
RN
Country [11] 0 0
Brazil
State/province [11] 0 0
SC
Country [12] 0 0
Brazil
State/province [12] 0 0
SP
Country [13] 0 0
China
State/province [13] 0 0
Guangdong
Country [14] 0 0
China
State/province [14] 0 0
Jilin
Country [15] 0 0
China
State/province [15] 0 0
Shanghai
Country [16] 0 0
China
State/province [16] 0 0
Shanxi
Country [17] 0 0
China
State/province [17] 0 0
Sichuan
Country [18] 0 0
China
State/province [18] 0 0
Zhejiang
Country [19] 0 0
China
State/province [19] 0 0
Beijing
Country [20] 0 0
China
State/province [20] 0 0
Chongqing
Country [21] 0 0
China
State/province [21] 0 0
Guang Dong Province
Country [22] 0 0
China
State/province [22] 0 0
Tianjin
Country [23] 0 0
Colombia
State/province [23] 0 0
Cundinamarca
Country [24] 0 0
Colombia
State/province [24] 0 0
Monteria
Country [25] 0 0
Denmark
State/province [25] 0 0
Herlev
Country [26] 0 0
Denmark
State/province [26] 0 0
Odense C
Country [27] 0 0
France
State/province [27] 0 0
Haute Vienne
Country [28] 0 0
France
State/province [28] 0 0
Val De Marne
Country [29] 0 0
France
State/province [29] 0 0
Caen
Country [30] 0 0
France
State/province [30] 0 0
Grenoble
Country [31] 0 0
France
State/province [31] 0 0
Lille
Country [32] 0 0
France
State/province [32] 0 0
Paris 10
Country [33] 0 0
France
State/province [33] 0 0
Pierre Benite
Country [34] 0 0
France
State/province [34] 0 0
Rennes
Country [35] 0 0
France
State/province [35] 0 0
Strasbourg Cedex
Country [36] 0 0
France
State/province [36] 0 0
Villejuif
Country [37] 0 0
Germany
State/province [37] 0 0
Coswig
Country [38] 0 0
Germany
State/province [38] 0 0
Essen
Country [39] 0 0
Germany
State/province [39] 0 0
Gottingen
Country [40] 0 0
Germany
State/province [40] 0 0
Grosshansdorf
Country [41] 0 0
Germany
State/province [41] 0 0
Heidelberg
Country [42] 0 0
Germany
State/province [42] 0 0
Koeln
Country [43] 0 0
Germany
State/province [43] 0 0
Oldenburg
Country [44] 0 0
Germany
State/province [44] 0 0
Tuebingen
Country [45] 0 0
Germany
State/province [45] 0 0
Ulm
Country [46] 0 0
Germany
State/province [46] 0 0
Wiesbaden
Country [47] 0 0
Greece
State/province [47] 0 0
GR
Country [48] 0 0
Greece
State/province [48] 0 0
Heraklion Crete
Country [49] 0 0
Hungary
State/province [49] 0 0
Zala
Country [50] 0 0
Hungary
State/province [50] 0 0
Budapest
Country [51] 0 0
Hungary
State/province [51] 0 0
Nyiregyhaza
Country [52] 0 0
Hungary
State/province [52] 0 0
Veszprem
Country [53] 0 0
India
State/province [53] 0 0
Andhra Pradesh
Country [54] 0 0
India
State/province [54] 0 0
Delhi
Country [55] 0 0
India
State/province [55] 0 0
Karnataka
Country [56] 0 0
India
State/province [56] 0 0
Kerala
Country [57] 0 0
India
State/province [57] 0 0
Maharashtra
Country [58] 0 0
India
State/province [58] 0 0
Rajasthan
Country [59] 0 0
India
State/province [59] 0 0
Tamil Nadu
Country [60] 0 0
India
State/province [60] 0 0
TamilNadu
Country [61] 0 0
India
State/province [61] 0 0
West Bengal
Country [62] 0 0
India
State/province [62] 0 0
Mumbai
Country [63] 0 0
Ireland
State/province [63] 0 0
Dublin 4
Country [64] 0 0
Italy
State/province [64] 0 0
AN
Country [65] 0 0
Italy
State/province [65] 0 0
BG
Country [66] 0 0
Italy
State/province [66] 0 0
GE
Country [67] 0 0
Italy
State/province [67] 0 0
MB
Country [68] 0 0
Italy
State/province [68] 0 0
MI
Country [69] 0 0
Italy
State/province [69] 0 0
PG
Country [70] 0 0
Italy
State/province [70] 0 0
PI
Country [71] 0 0
Italy
State/province [71] 0 0
PN
Country [72] 0 0
Italy
State/province [72] 0 0
PR
Country [73] 0 0
Italy
State/province [73] 0 0
RE
Country [74] 0 0
Italy
State/province [74] 0 0
RM
Country [75] 0 0
Italy
State/province [75] 0 0
TO
Country [76] 0 0
Italy
State/province [76] 0 0
UD
Country [77] 0 0
Italy
State/province [77] 0 0
Napoli
Country [78] 0 0
Japan
State/province [78] 0 0
Aichi
Country [79] 0 0
Japan
State/province [79] 0 0
Chiba
Country [80] 0 0
Japan
State/province [80] 0 0
Hyogo
Country [81] 0 0
Japan
State/province [81] 0 0
Osaka
Country [82] 0 0
Japan
State/province [82] 0 0
Tokyo
Country [83] 0 0
Japan
State/province [83] 0 0
Niigata
Country [84] 0 0
Korea, Republic of
State/province [84] 0 0
Gyeonggi Do
Country [85] 0 0
Korea, Republic of
State/province [85] 0 0
Korea
Country [86] 0 0
Korea, Republic of
State/province [86] 0 0
Seoul
Country [87] 0 0
Lebanon
State/province [87] 0 0
Ashrafieh
Country [88] 0 0
Lebanon
State/province [88] 0 0
Saida
Country [89] 0 0
Mexico
State/province [89] 0 0
Jalisco
Country [90] 0 0
Netherlands
State/province [90] 0 0
Zuid Holland
Country [91] 0 0
Netherlands
State/province [91] 0 0
Amersfroort
Country [92] 0 0
Netherlands
State/province [92] 0 0
Enschede
Country [93] 0 0
Netherlands
State/province [93] 0 0
Groningen
Country [94] 0 0
Netherlands
State/province [94] 0 0
Maastricht
Country [95] 0 0
Netherlands
State/province [95] 0 0
Zoetermeer
Country [96] 0 0
Norway
State/province [96] 0 0
Oslo
Country [97] 0 0
Poland
State/province [97] 0 0
Szczecin
Country [98] 0 0
Poland
State/province [98] 0 0
Warszawa
Country [99] 0 0
Russian Federation
State/province [99] 0 0
Moscow
Country [100] 0 0
Russian Federation
State/province [100] 0 0
Saint Petersburg
Country [101] 0 0
Singapore
State/province [101] 0 0
Singapore
Country [102] 0 0
Spain
State/province [102] 0 0
Andalucia
Country [103] 0 0
Spain
State/province [103] 0 0
Asturias
Country [104] 0 0
Spain
State/province [104] 0 0
Cataluna
Country [105] 0 0
Spain
State/province [105] 0 0
Catalunya
Country [106] 0 0
Spain
State/province [106] 0 0
Comunidad Valenciana
Country [107] 0 0
Spain
State/province [107] 0 0
Extremadura
Country [108] 0 0
Spain
State/province [108] 0 0
Galicia
Country [109] 0 0
Spain
State/province [109] 0 0
Islas Baleares
Country [110] 0 0
Spain
State/province [110] 0 0
Navarra
Country [111] 0 0
Spain
State/province [111] 0 0
Santa Cruz De Tenerife
Country [112] 0 0
Spain
State/province [112] 0 0
Barcelona
Country [113] 0 0
Spain
State/province [113] 0 0
Madrid
Country [114] 0 0
Sweden
State/province [114] 0 0
Linkoping
Country [115] 0 0
Sweden
State/province [115] 0 0
Lund
Country [116] 0 0
Sweden
State/province [116] 0 0
Stockholm
Country [117] 0 0
Sweden
State/province [117] 0 0
Uppsala
Country [118] 0 0
Taiwan
State/province [118] 0 0
Kaohsiung
Country [119] 0 0
Taiwan
State/province [119] 0 0
Taichung
Country [120] 0 0
Taiwan
State/province [120] 0 0
Taipei
Country [121] 0 0
Taiwan
State/province [121] 0 0
Taoyuan
Country [122] 0 0
Thailand
State/province [122] 0 0
Hat Yai
Country [123] 0 0
Thailand
State/province [123] 0 0
THA
Country [124] 0 0
Thailand
State/province [124] 0 0
Bangkok
Country [125] 0 0
Turkey
State/province [125] 0 0
Ankara
Country [126] 0 0
Turkey
State/province [126] 0 0
Istanbul
Country [127] 0 0
United Kingdom
State/province [127] 0 0
Devon
Country [128] 0 0
United Kingdom
State/province [128] 0 0
West Yorkshire
Country [129] 0 0
United Kingdom
State/province [129] 0 0
Birmingham
Country [130] 0 0
United Kingdom
State/province [130] 0 0
London
Country [131] 0 0
United Kingdom
State/province [131] 0 0
Manchester
Country [132] 0 0
United Kingdom
State/province [132] 0 0
Nottingham

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT01828099