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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 patients were on continuous oral dosing of ceritinib 750 mg once daily in fasted state.

Active comparator: Chemotherapy - Chemotherapy patients (Induction per Investigator's choice) were on four 21-day cycles of Pemetrexed 500mg/m2 iv + Cisplatin 75 mg/m2 or Pemetrexed 500 mg/m2 iv + Carboplatin AUC 5-6 iv followed by Pemetrexed 500 mg/m2 every 21 days followed by Pemetrexed maintenance in non-progressors, etc (other usual rule to stop treatment).


Treatment: Drugs: 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.

Treatment: Drugs: 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.

Treatment: Drugs: Cisplatin
Cisplatin was administered by IV at a dose of 75 mg/m2 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 (assessed every 6 weeks up to approximately 34 months)
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
From randomization until death (up to approximately 34 months)
Secondary outcome [2] 0 0
Overall Response Rate (ORR)
Timepoint [2] 0 0
From randomization until death (up to approximately 34 months)
Secondary outcome [3] 0 0
Duration of Response (DOR)
Timepoint [3] 0 0
From randomization until death (up to approximately 34 months)
Secondary outcome [4] 0 0
Disease Control Rate (DCR)
Timepoint [4] 0 0
From randomization until death (up to approximately 34 months)
Secondary outcome [5] 0 0
Time to Response (TTR)
Timepoint [5] 0 0
From randomization until death (up to approximately 34 months)
Secondary outcome [6] 0 0
Patient Reported Outcomes
Timepoint [6] 0 0
Screening, followed by every 6 weeks until Month 33 after Month 33 every 9 weeks.

Eligibility
Key inclusion criteria
1. 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.
2. 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
3. Patient has at least one measurable lesion as defined by RECIST 1.1.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patient with known hypersensitivity to any of the excipients of LDK378 (microcrystalline cellulose, mannitol, crospovidone, colloidal silicon dioxide and magnesium stearate)
2. Patient with a history of severe hypersensitivity reaction to platinum containing drugs, pemetrexed or any known excipients of these drugs.
3. 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 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
Austria
State/province [1] 0 0
Salzburg
Country [2] 0 0
Austria
State/province [2] 0 0
Wien
Country [3] 0 0
Brazil
State/province [3] 0 0
Rio Grande Do Sul
Country [4] 0 0
Brazil
State/province [4] 0 0
RN
Country [5] 0 0
Brazil
State/province [5] 0 0
SC
Country [6] 0 0
Brazil
State/province [6] 0 0
SP
Country [7] 0 0
China
State/province [7] 0 0
Beijing
Country [8] 0 0
China
State/province [8] 0 0
Chongqing
Country [9] 0 0
China
State/province [9] 0 0
Guangdong
Country [10] 0 0
China
State/province [10] 0 0
Jilin
Country [11] 0 0
China
State/province [11] 0 0
Shanghai
Country [12] 0 0
China
State/province [12] 0 0
Shanxi
Country [13] 0 0
China
State/province [13] 0 0
Sichuan
Country [14] 0 0
China
State/province [14] 0 0
Zhejiang
Country [15] 0 0
China
State/province [15] 0 0
Guang Dong Province
Country [16] 0 0
China
State/province [16] 0 0
Tianjin
Country [17] 0 0
Colombia
State/province [17] 0 0
Monteria
Country [18] 0 0
Denmark
State/province [18] 0 0
Herlev
Country [19] 0 0
Denmark
State/province [19] 0 0
Odense C
Country [20] 0 0
France
State/province [20] 0 0
Val De Marne
Country [21] 0 0
France
State/province [21] 0 0
Caen
Country [22] 0 0
France
State/province [22] 0 0
Grenoble
Country [23] 0 0
France
State/province [23] 0 0
Lille Cedex
Country [24] 0 0
France
State/province [24] 0 0
Limoges Cedex
Country [25] 0 0
France
State/province [25] 0 0
Paris 10
Country [26] 0 0
France
State/province [26] 0 0
Pierre Benite
Country [27] 0 0
France
State/province [27] 0 0
Rennes
Country [28] 0 0
France
State/province [28] 0 0
Strasbourg Cedex
Country [29] 0 0
France
State/province [29] 0 0
Villejuif
Country [30] 0 0
Germany
State/province [30] 0 0
Gottingen
Country [31] 0 0
Germany
State/province [31] 0 0
Heidelberg
Country [32] 0 0
Germany
State/province [32] 0 0
Tuebingen
Country [33] 0 0
Germany
State/province [33] 0 0
Ulm
Country [34] 0 0
Germany
State/province [34] 0 0
Wiesbaden
Country [35] 0 0
Greece
State/province [35] 0 0
Heraklion Crete
Country [36] 0 0
India
State/province [36] 0 0
Andhra Pradesh
Country [37] 0 0
India
State/province [37] 0 0
Karnataka
Country [38] 0 0
India
State/province [38] 0 0
Maharashtra
Country [39] 0 0
India
State/province [39] 0 0
Rajasthan
Country [40] 0 0
India
State/province [40] 0 0
Tamil Nadu
Country [41] 0 0
India
State/province [41] 0 0
West Bengal
Country [42] 0 0
India
State/province [42] 0 0
Delhi
Country [43] 0 0
India
State/province [43] 0 0
Mumbai
Country [44] 0 0
Ireland
State/province [44] 0 0
Dublin 4
Country [45] 0 0
Italy
State/province [45] 0 0
AN
Country [46] 0 0
Italy
State/province [46] 0 0
BG
Country [47] 0 0
Italy
State/province [47] 0 0
GE
Country [48] 0 0
Italy
State/province [48] 0 0
MB
Country [49] 0 0
Italy
State/province [49] 0 0
MI
Country [50] 0 0
Italy
State/province [50] 0 0
PG
Country [51] 0 0
Italy
State/province [51] 0 0
PI
Country [52] 0 0
Italy
State/province [52] 0 0
PN
Country [53] 0 0
Italy
State/province [53] 0 0
PR
Country [54] 0 0
Italy
State/province [54] 0 0
RE
Country [55] 0 0
Italy
State/province [55] 0 0
RM
Country [56] 0 0
Italy
State/province [56] 0 0
TO
Country [57] 0 0
Italy
State/province [57] 0 0
UD
Country [58] 0 0
Italy
State/province [58] 0 0
Napoli
Country [59] 0 0
Japan
State/province [59] 0 0
Aichi
Country [60] 0 0
Japan
State/province [60] 0 0
Chiba
Country [61] 0 0
Japan
State/province [61] 0 0
Hyogo
Country [62] 0 0
Japan
State/province [62] 0 0
Osaka
Country [63] 0 0
Japan
State/province [63] 0 0
Tokyo
Country [64] 0 0
Japan
State/province [64] 0 0
Niigata
Country [65] 0 0
Korea, Republic of
State/province [65] 0 0
Gyeonggi Do
Country [66] 0 0
Korea, Republic of
State/province [66] 0 0
Korea
Country [67] 0 0
Korea, Republic of
State/province [67] 0 0
Seoul
Country [68] 0 0
Lebanon
State/province [68] 0 0
Ashrafieh
Country [69] 0 0
Lebanon
State/province [69] 0 0
Saida
Country [70] 0 0
Mexico
State/province [70] 0 0
Jalisco
Country [71] 0 0
Netherlands
State/province [71] 0 0
AZ
Country [72] 0 0
Netherlands
State/province [72] 0 0
Amsterdam
Country [73] 0 0
Netherlands
State/province [73] 0 0
Breda
Country [74] 0 0
Netherlands
State/province [74] 0 0
Groningen
Country [75] 0 0
Netherlands
State/province [75] 0 0
Leiden
Country [76] 0 0
Norway
State/province [76] 0 0
Oslo
Country [77] 0 0
Poland
State/province [77] 0 0
Szczecin
Country [78] 0 0
Poland
State/province [78] 0 0
Warszawa
Country [79] 0 0
Russian Federation
State/province [79] 0 0
Moscow
Country [80] 0 0
Russian Federation
State/province [80] 0 0
Saint Petersburg
Country [81] 0 0
Singapore
State/province [81] 0 0
Singapore
Country [82] 0 0
Spain
State/province [82] 0 0
Andalucia
Country [83] 0 0
Spain
State/province [83] 0 0
Asturias
Country [84] 0 0
Spain
State/province [84] 0 0
Catalunya
Country [85] 0 0
Spain
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Extremadura
Country [86] 0 0
Spain
State/province [86] 0 0
Galicia
Country [87] 0 0
Spain
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Tarragona
Country [88] 0 0
Spain
State/province [88] 0 0
Barcelona
Country [89] 0 0
Spain
State/province [89] 0 0
Madrid
Country [90] 0 0
Sweden
State/province [90] 0 0
Linkoping
Country [91] 0 0
Sweden
State/province [91] 0 0
Lund
Country [92] 0 0
Sweden
State/province [92] 0 0
Stockholm
Country [93] 0 0
Sweden
State/province [93] 0 0
Uppsala
Country [94] 0 0
Taiwan
State/province [94] 0 0
Taiwan, ROC
Country [95] 0 0
Taiwan
State/province [95] 0 0
Taoyuan
Country [96] 0 0
Taiwan
State/province [96] 0 0
Kaohsiung
Country [97] 0 0
Taiwan
State/province [97] 0 0
Taichung City
Country [98] 0 0
Taiwan
State/province [98] 0 0
Taichung
Country [99] 0 0
Taiwan
State/province [99] 0 0
Taipei
Country [100] 0 0
Thailand
State/province [100] 0 0
Hat Yai
Country [101] 0 0
Thailand
State/province [101] 0 0
THA
Country [102] 0 0
Thailand
State/province [102] 0 0
Bangkok
Country [103] 0 0
Turkey
State/province [103] 0 0
Sihhiye
Country [104] 0 0
Turkey
State/province [104] 0 0
Istanbul
Country [105] 0 0
United Kingdom
State/province [105] 0 0
West Yorkshire
Country [106] 0 0
United Kingdom
State/province [106] 0 0
Birmingham
Country [107] 0 0
United Kingdom
State/province [107] 0 0
London
Country [108] 0 0
United Kingdom
State/province [108] 0 0
Manchester

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