Register a trial

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

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/NCT04538664




Registration number
NCT04538664
Ethics application status
Date submitted
31/08/2020
Date registered
4/09/2020

Titles & IDs
Public title
A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Characterized by Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions
Scientific title
A Randomized, Open-label Phase 3 Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Patients With EGFR Exon 20ins Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Secondary ID [1] 0 0
2020-000633-40
Secondary ID [2] 0 0
CR108850
Universal Trial Number (UTN)
Trial acronym
PAPILLON
Linked study record

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

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - Amivantamab
Treatment: Drugs - Pemetrexed
Treatment: Drugs - Carboplatin
Treatment: Drugs - Pemetrexed

Experimental: Arm A: Amivantamab + Chemotherapy - Participants will receive pemetrexed 500 milligram per meter square (mg/m\^2) intravenous (IV) infusion (with vitamin supplementation) on Day 1 of each 21-day cycle, in combination with carboplatin for up to 4 cycles, and then as maintenance monotherapy until disease progression. Carboplatin area under the concentration-time curve 5 milligram per milliliter (mg/mL) per minute (AUC 5) will be administered as IV infusion on Day 1 of each 21 day cycle, for up to 4 cycles. Participants will receive amivantamab 1400 mg (1750 mg if body weight is \>=80 kilogram \[kg\]) by IV infusion once weekly up to Cycle 2 Day 1, then 1750 mg (2100 mg if body weight is \>=80 kg) on Day 1 of each 21-day cycle, starting with Cycle 3. Following the primary analysis for efficacy, the study will transition to an OLE phase and participants will continue to receive the amivantamab plus chemotherapy in OLE phase. Participants who completed OLE period will enter LTE period and continue to receive same treatment.

Experimental: Arm B: Chemotherapy Alone - Participants will receive pemetrexed 500 mg/m\^2 IV infusion (with vitamin supplementation) on Day 1 of each 21-day cycle, in combination with carboplatin for up to 4 cycles, and then as maintenance monotherapy until disease progression. Carboplatin AUC 5 IV infusion will be administered on Day 1 of each 21-day cycle for up to 4 cycles. Following the primary analysis for efficacy, the study will transition to an OLE phase and participants will either continue to receive the chemotherapy or cross over to amivantamab in OLE phase. Participants who completed OLE period will enter LTE period and continue to receive same treatment.


Treatment: Drugs: Amivantamab
Amivantamab will be administered as an IV infusion at a dose of 1400 mg (1750 mg if body weight is \>=80 kilogram \[kg\]) by once weekly up to Cycle 2 Day 1, then 1750 mg (2100 mg if body weight is \>=80 kg) on Day 1 of each 21-day cycle, starting with Cycle 3 and will continue the same treatment in OLE phase then in LTE phase.

Treatment: Drugs: Pemetrexed
Pemetrexed will be administered as 500 mg/m\^2 IV infusion (with vitamin supplementation) on Day 1 of each 21-day cycle and then as maintenance monotherapy until disease progression in Arm A and will continue the same treatment in OLE phase then in LTE phase.

Treatment: Drugs: Carboplatin
Carboplatin will be administered as AUC 5 IV infusion for up to 4 cycles on Day 1 of each 21-day cycle.

Treatment: Drugs: Pemetrexed
Pemetrexed will be administered as 500 mg/m\^2 IV infusion (with vitamin supplementation) on Day 1 of each 21-day cycle and then as maintenance monotherapy until disease progression in Arm B and will continue the same treatment in OLE phase then in LTE phase.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Blinded Independent Central Review (BICR)
Timepoint [1] 0 0
From randomization to either disease progression or death whichever occurs first (up to 29 months)
Secondary outcome [1] 0 0
Objective Response Rate (ORR)
Timepoint [1] 0 0
Up to 5 years 3 months
Secondary outcome [2] 0 0
Duration of Response (DoR)
Timepoint [2] 0 0
Up to 5 years 3 months
Secondary outcome [3] 0 0
Overall Survival (OS)
Timepoint [3] 0 0
Up to 5 years 3 months
Secondary outcome [4] 0 0
Time to Subsequent Therapy (TST)
Timepoint [4] 0 0
Up to 5 years 3 months
Secondary outcome [5] 0 0
Progression-Free Survival After First Subsequent Therapy (PFS2)
Timepoint [5] 0 0
Up to 5 years 3 months
Secondary outcome [6] 0 0
Time to Symptomatic Progression (TTSP)
Timepoint [6] 0 0
Up to 5 years 3 months
Secondary outcome [7] 0 0
Number of Participants Treatment-emergent Adverse Events (TEAEs)
Timepoint [7] 0 0
From Day 1 to 5 years 2 months
Secondary outcome [8] 0 0
Number of Participants TEAEs With Severity
Timepoint [8] 0 0
From Day 1 to 5 years 2 months
Secondary outcome [9] 0 0
Number of Participants With Clinical Laboratory Abnormalities
Timepoint [9] 0 0
Up to 5 years 3 months
Secondary outcome [10] 0 0
Number of Participants With Vital Signs Abnormalities
Timepoint [10] 0 0
Up to 5 years 3 months
Secondary outcome [11] 0 0
Number of Participants With Physical Examination Abnormalities
Timepoint [11] 0 0
Up to 5 years 3 months
Secondary outcome [12] 0 0
Serum Concentration of Amivantamab
Timepoint [12] 0 0
Day 1 (Cycles 1, 2, 3, 5, 7, 9, 11, 13), Day 2 (Cycle 1)
Secondary outcome [13] 0 0
Number of Participants With Anti-Amivantamab Antibodies
Timepoint [13] 0 0
Day 1 (Cycles 1, 2, 3, 5, 7, 9, 11, 13), Day 2 (Cycle 1)
Secondary outcome [14] 0 0
Change From Baseline in European Organization of Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)
Timepoint [14] 0 0
From baseline to 5 years 3 months
Secondary outcome [15] 0 0
Change From Baseline in Patient Reported Outcomes Measurement Information System-Physical Function (PROMIS-PF)
Timepoint [15] 0 0
From baseline to 5 years 3 months

Eligibility
Key inclusion criteria
* Participant must have histologically or cytologically confirmed, locally advanced or metastatic, nonsquamous non-small cell lung cancer (NSCLC) with documented primary epidermal growth factor receptor (EGFR) Exon 20ins activating mutation
* Participant must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
* Participant must have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Participant must agree to genetic characterization of tumor status through the required pretreatment tumor biopsy (or submission of equivalent archival material), as well as baseline and periodic blood samples for analysis of tumor mutations in the bloodstream
* A female participant of childbearing potential must have a negative serum or urine test at screening and within 72 hours of the first dose of study treatment and must agree to further serum or urine pregnancy tests during the study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Participant has evidence of synchronous NSCLC disease (as suggested by genetic characterization or radiographic appearance)
* Participant has untreated brain metastases (a participant with definitively, locally treated metastases who is clinically stable, asymptomatic, and off corticosteroid treatment for at least 2 weeks prior to randomization is eligible)
* Participant has history of spinal cord compression that has not been treated definitively with surgery or radiation
* Participant has a medical history of interstitial lung disease (ILD), including drug-induced ILD, or radiation pneumonitis
* Participant has a contraindication to the use of carboplatin or pemetrexed (refer to local prescribing information for each agent). Participant has a history of hypersensitivity to, or cannot take, vitamin B12 or folic acid

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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/10/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/01/2026
Actual
Sample size
Target
Accrual to date
Final
308
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [2] 0 0
St George Hospital - Kogarah
Recruitment hospital [3] 0 0
Cabrini Medical Centre - Malvern
Recruitment hospital [4] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
3144 - Malvern
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
District of Columbia
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
New Jersey
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
Oregon
Country [10] 0 0
United States of America
State/province [10] 0 0
South Dakota
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
United States of America
State/province [12] 0 0
Utah
Country [13] 0 0
United States of America
State/province [13] 0 0
Virginia
Country [14] 0 0
Belgium
State/province [14] 0 0
Leuven
Country [15] 0 0
Belgium
State/province [15] 0 0
Roeselare
Country [16] 0 0
Belgium
State/province [16] 0 0
Yvoir
Country [17] 0 0
Brazil
State/province [17] 0 0
Barretos
Country [18] 0 0
Brazil
State/province [18] 0 0
Belo Horizonte
Country [19] 0 0
Brazil
State/province [19] 0 0
Florianopolis
Country [20] 0 0
Brazil
State/province [20] 0 0
Ijui
Country [21] 0 0
Brazil
State/province [21] 0 0
Natal
Country [22] 0 0
Brazil
State/province [22] 0 0
Pelotas
Country [23] 0 0
Brazil
State/province [23] 0 0
Porto Alegre
Country [24] 0 0
Brazil
State/province [24] 0 0
Rio De Janeiro
Country [25] 0 0
Brazil
State/province [25] 0 0
Rio de Janeiro
Country [26] 0 0
Brazil
State/province [26] 0 0
Sao Paulo
Country [27] 0 0
Brazil
State/province [27] 0 0
Sorocaba
Country [28] 0 0
Brazil
State/province [28] 0 0
Vitoria
Country [29] 0 0
Canada
State/province [29] 0 0
Ontario
Country [30] 0 0
Canada
State/province [30] 0 0
Quebec
Country [31] 0 0
China
State/province [31] 0 0
Beijing
Country [32] 0 0
China
State/province [32] 0 0
Changchun
Country [33] 0 0
China
State/province [33] 0 0
Changsha
Country [34] 0 0
China
State/province [34] 0 0
Changzhou
Country [35] 0 0
China
State/province [35] 0 0
Chengdu
Country [36] 0 0
China
State/province [36] 0 0
Chongqing
Country [37] 0 0
China
State/province [37] 0 0
Fuzhou
Country [38] 0 0
China
State/province [38] 0 0
Guang Zhou
Country [39] 0 0
China
State/province [39] 0 0
Hang Zhou
Country [40] 0 0
China
State/province [40] 0 0
Hangzhou
Country [41] 0 0
China
State/province [41] 0 0
Harbin
Country [42] 0 0
China
State/province [42] 0 0
Linhai
Country [43] 0 0
China
State/province [43] 0 0
Nanjing
Country [44] 0 0
China
State/province [44] 0 0
Shanghai
Country [45] 0 0
China
State/province [45] 0 0
Shenyang
Country [46] 0 0
China
State/province [46] 0 0
Shenzhen
Country [47] 0 0
China
State/province [47] 0 0
Tianjin
Country [48] 0 0
China
State/province [48] 0 0
Weifang
Country [49] 0 0
China
State/province [49] 0 0
Wuhan
Country [50] 0 0
China
State/province [50] 0 0
Wuxi
Country [51] 0 0
China
State/province [51] 0 0
XI An
Country [52] 0 0
China
State/province [52] 0 0
Yantai
Country [53] 0 0
China
State/province [53] 0 0
Zhengzhou
Country [54] 0 0
France
State/province [54] 0 0
Bordeaux
Country [55] 0 0
France
State/province [55] 0 0
Bron
Country [56] 0 0
France
State/province [56] 0 0
Dijon
Country [57] 0 0
France
State/province [57] 0 0
le mans Cedex 9
Country [58] 0 0
France
State/province [58] 0 0
Lille CEDEX
Country [59] 0 0
France
State/province [59] 0 0
NANTES cedex 1
Country [60] 0 0
France
State/province [60] 0 0
Paris
Country [61] 0 0
France
State/province [61] 0 0
Pessac
Country [62] 0 0
France
State/province [62] 0 0
Saint Mande
Country [63] 0 0
Germany
State/province [63] 0 0
Bad Berka
Country [64] 0 0
Germany
State/province [64] 0 0
Berlin
Country [65] 0 0
Germany
State/province [65] 0 0
Gauting
Country [66] 0 0
Germany
State/province [66] 0 0
Heidelberg
Country [67] 0 0
Germany
State/province [67] 0 0
Heilbronn
Country [68] 0 0
Germany
State/province [68] 0 0
Koeln
Country [69] 0 0
Germany
State/province [69] 0 0
Moers
Country [70] 0 0
Germany
State/province [70] 0 0
Oldenburg
Country [71] 0 0
Germany
State/province [71] 0 0
Recklinghausen
Country [72] 0 0
Hungary
State/province [72] 0 0
Budapest
Country [73] 0 0
Hungary
State/province [73] 0 0
Gyöngyös
Country [74] 0 0
Hungary
State/province [74] 0 0
Szekesfehervar
Country [75] 0 0
Hungary
State/province [75] 0 0
Szombathely
Country [76] 0 0
Hungary
State/province [76] 0 0
Torokbalint
Country [77] 0 0
India
State/province [77] 0 0
Hyderabad
Country [78] 0 0
India
State/province [78] 0 0
Kolkata
Country [79] 0 0
India
State/province [79] 0 0
Mumbai
Country [80] 0 0
India
State/province [80] 0 0
Nasik
Country [81] 0 0
India
State/province [81] 0 0
New Delhi
Country [82] 0 0
India
State/province [82] 0 0
Pune
Country [83] 0 0
Israel
State/province [83] 0 0
Jerusalem
Country [84] 0 0
Israel
State/province [84] 0 0
Kfar Saba
Country [85] 0 0
Israel
State/province [85] 0 0
Petah Tikva
Country [86] 0 0
Israel
State/province [86] 0 0
Tel-Aviv
Country [87] 0 0
Italy
State/province [87] 0 0
Bologna
Country [88] 0 0
Italy
State/province [88] 0 0
Catania
Country [89] 0 0
Italy
State/province [89] 0 0
Meldola
Country [90] 0 0
Italy
State/province [90] 0 0
Milano
Country [91] 0 0
Italy
State/province [91] 0 0
Monza
Country [92] 0 0
Italy
State/province [92] 0 0
Ravenna
Country [93] 0 0
Italy
State/province [93] 0 0
Roma
Country [94] 0 0
Italy
State/province [94] 0 0
Rozzano
Country [95] 0 0
Japan
State/province [95] 0 0
Bunkyo Ku
Country [96] 0 0
Japan
State/province [96] 0 0
Hidaka
Country [97] 0 0
Japan
State/province [97] 0 0
Himeji
Country [98] 0 0
Japan
State/province [98] 0 0
Hirakata
Country [99] 0 0
Japan
State/province [99] 0 0
Kanazawa
Country [100] 0 0
Japan
State/province [100] 0 0
Kashiwa
Country [101] 0 0
Japan
State/province [101] 0 0
Kishiwada
Country [102] 0 0
Japan
State/province [102] 0 0
Kobe
Country [103] 0 0
Japan
State/province [103] 0 0
Kurashiki
Country [104] 0 0
Japan
State/province [104] 0 0
Kurume
Country [105] 0 0
Japan
State/province [105] 0 0
Matsusaka
Country [106] 0 0
Japan
State/province [106] 0 0
Nagoya Shi
Country [107] 0 0
Japan
State/province [107] 0 0
Nagoya-shi
Country [108] 0 0
Japan
State/province [108] 0 0
Niigata
Country [109] 0 0
Japan
State/province [109] 0 0
Osaka Sayama shi
Country [110] 0 0
Japan
State/province [110] 0 0
Sagamihara
Country [111] 0 0
Japan
State/province [111] 0 0
Sapporo-shi
Country [112] 0 0
Japan
State/province [112] 0 0
Shiwa-gun
Country [113] 0 0
Japan
State/province [113] 0 0
Shizuoka
Country [114] 0 0
Japan
State/province [114] 0 0
Tokyo
Country [115] 0 0
Japan
State/province [115] 0 0
Toon-shi
Country [116] 0 0
Japan
State/province [116] 0 0
Wakayama
Country [117] 0 0
Japan
State/province [117] 0 0
Yamaguchi
Country [118] 0 0
Korea, Republic of
State/province [118] 0 0
Busan
Country [119] 0 0
Korea, Republic of
State/province [119] 0 0
Gyeonggi-do
Country [120] 0 0
Korea, Republic of
State/province [120] 0 0
Gyeongsangnam-do
Country [121] 0 0
Korea, Republic of
State/province [121] 0 0
Jeollanam-do
Country [122] 0 0
Korea, Republic of
State/province [122] 0 0
Seongnam-si
Country [123] 0 0
Korea, Republic of
State/province [123] 0 0
Seoul
Country [124] 0 0
Malaysia
State/province [124] 0 0
George Town
Country [125] 0 0
Malaysia
State/province [125] 0 0
Johor Bahru
Country [126] 0 0
Malaysia
State/province [126] 0 0
Kuala Lumpur
Country [127] 0 0
Mexico
State/province [127] 0 0
Chihuahua
Country [128] 0 0
Mexico
State/province [128] 0 0
Ciudad de Mexico
Country [129] 0 0
Mexico
State/province [129] 0 0
Guadalajara
Country [130] 0 0
Mexico
State/province [130] 0 0
Mexico
Country [131] 0 0
Mexico
State/province [131] 0 0
Monterrey
Country [132] 0 0
Mexico
State/province [132] 0 0
Naucalpan
Country [133] 0 0
Poland
State/province [133] 0 0
Bydgoszcz
Country [134] 0 0
Poland
State/province [134] 0 0
Gdansk
Country [135] 0 0
Poland
State/province [135] 0 0
Gdynia
Country [136] 0 0
Poland
State/province [136] 0 0
Olsztyn
Country [137] 0 0
Poland
State/province [137] 0 0
Poznan
Country [138] 0 0
Poland
State/province [138] 0 0
Warszawa
Country [139] 0 0
Portugal
State/province [139] 0 0
Lisboa
Country [140] 0 0
Portugal
State/province [140] 0 0
Porto
Country [141] 0 0
Portugal
State/province [141] 0 0
Vila Nova de Gaia
Country [142] 0 0
Puerto Rico
State/province [142] 0 0
Rio Piedras
Country [143] 0 0
Russian Federation
State/province [143] 0 0
Irkutsk
Country [144] 0 0
Russian Federation
State/province [144] 0 0
Krasnogorsk
Country [145] 0 0
Russian Federation
State/province [145] 0 0
Krasnoyarsk
Country [146] 0 0
Russian Federation
State/province [146] 0 0
Kuzmolovsky
Country [147] 0 0
Russian Federation
State/province [147] 0 0
Moscow
Country [148] 0 0
Russian Federation
State/province [148] 0 0
Nalchik
Country [149] 0 0
Russian Federation
State/province [149] 0 0
Nizhniy Novgorod
Country [150] 0 0
Russian Federation
State/province [150] 0 0
Saint Petersburg
Country [151] 0 0
Russian Federation
State/province [151] 0 0
Saint-Petersburg
Country [152] 0 0
Russian Federation
State/province [152] 0 0
St-Petersburg
Country [153] 0 0
Russian Federation
State/province [153] 0 0
Tomsk
Country [154] 0 0
Russian Federation
State/province [154] 0 0
Ufa
Country [155] 0 0
Russian Federation
State/province [155] 0 0
Yaroslavl
Country [156] 0 0
Spain
State/province [156] 0 0
A Coruna
Country [157] 0 0
Spain
State/province [157] 0 0
Badalona
Country [158] 0 0
Spain
State/province [158] 0 0
Barcelona
Country [159] 0 0
Spain
State/province [159] 0 0
Burgos
Country [160] 0 0
Spain
State/province [160] 0 0
Madrid
Country [161] 0 0
Spain
State/province [161] 0 0
Majadahonda
Country [162] 0 0
Spain
State/province [162] 0 0
Málaga
Country [163] 0 0
Spain
State/province [163] 0 0
Pamplona
Country [164] 0 0
Spain
State/province [164] 0 0
Seville
Country [165] 0 0
Spain
State/province [165] 0 0
Zaragoza
Country [166] 0 0
Taiwan
State/province [166] 0 0
Kaohsiung
Country [167] 0 0
Taiwan
State/province [167] 0 0
New Taipei
Country [168] 0 0
Taiwan
State/province [168] 0 0
Taichung
Country [169] 0 0
Taiwan
State/province [169] 0 0
Taipei City
Country [170] 0 0
Thailand
State/province [170] 0 0
Bangkok
Country [171] 0 0
Thailand
State/province [171] 0 0
Songkla
Country [172] 0 0
Turkey
State/province [172] 0 0
Adana
Country [173] 0 0
Turkey
State/province [173] 0 0
Ankara
Country [174] 0 0
Turkey
State/province [174] 0 0
Edirne
Country [175] 0 0
Turkey
State/province [175] 0 0
Istanbul
Country [176] 0 0
Turkey
State/province [176] 0 0
Izmir
Country [177] 0 0
Ukraine
State/province [177] 0 0
Dnipro
Country [178] 0 0
Ukraine
State/province [178] 0 0
Kyiv
Country [179] 0 0
United Kingdom
State/province [179] 0 0
Edinburgh
Country [180] 0 0
United Kingdom
State/province [180] 0 0
London
Country [181] 0 0
United Kingdom
State/province [181] 0 0
Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
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?
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency.

As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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?
IPD available at link: https://www.janssen.com/clinical-trials/transparency


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04538664