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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04025879




Registration number
NCT04025879
Ethics application status
Date submitted
17/07/2019
Date registered
19/07/2019
Date last updated
23/07/2024

Titles & IDs
Public title
A Study of Neoadjuvant Chemotherapy Plus Nivolumab Versus Neoadjuvant Chemotherapy Plus Placebo, Followed by Surgical Removal and Adjuvant Treatment With Nivolumab or Placebo for Participants With Surgically Removable Early Stage Non-small Cell Lung Cancer
Scientific title
A Phase 3, Randomized, Double-blind Study of Neoadjuvant Chemotherapy Plus Nivolumab Versus Neoadjuvant Chemotherapy Plus Placebo, Followed by Surgical Resection and Adjuvant Treatment With Nivolumab or Placebo for Participants With Resectable Stage II-IIIB Non-small Cell Lung Cancer
Secondary ID [1] 0 0
2019-000262-38
Secondary ID [2] 0 0
CA209-77T
Universal Trial Number (UTN)
Trial acronym
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
Description of intervention(s) / exposure
Treatment: Other - Nivolumab
Treatment: Drugs - Carboplatin
Treatment: Drugs - Cisplatin
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Pemetrexed
Treatment: Drugs - Placebo
Treatment: Drugs - Docetaxel

Experimental: Neoadj. Nivo+ Pt-based Doublet Chemo followed by Adj. Nivo -

Placebo comparator: Neoadj. Plac. + Pt-based Doublet Chemo followed by Adj.Plac. -


Treatment: Other: Nivolumab
Specified dose on specified days

Treatment: Drugs: Carboplatin
Specified dose on specified days

Treatment: Drugs: Cisplatin
Specified dose on specified days

Treatment: Drugs: Paclitaxel
Specified dose on specified days

Treatment: Drugs: Pemetrexed
Specified dose on specified days

Treatment: Drugs: Placebo
Specified dose on specified days

Treatment: Drugs: Docetaxel
Specified dose on specified days
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Event-Free Survival (EFS) by BICR
Timepoint [1] 0 0
From randomization to disease progression, worsening, recurrence, or death due to any cause (up to approximately 44 months)
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
From randomization and the date of death due to any cause.
Secondary outcome [2] 0 0
Pathologic Complete Response (pCR) Rate
Timepoint [2] 0 0
From randomization up to approximately 44 months
Secondary outcome [3] 0 0
Major Pathological Response (MPR) Rate
Timepoint [3] 0 0
From randomization up to approximately 44 months
Secondary outcome [4] 0 0
The Number of Participants With Adverse Events (AEs)
Timepoint [4] 0 0
From first treatment to 30 days after last treatment of study therapy including definitive surgery and radiotherapy (up to approximately 28 months)
Secondary outcome [5] 0 0
The Number of Participants With Serious Adverse Events (SAEs)
Timepoint [5] 0 0
From first treatment to 30 days after last treatment of study therapy including definitive surgery and radiotherapy (up to approximately 28 months)
Secondary outcome [6] 0 0
The Number of Participants With Select Adverse Events (AEs)
Timepoint [6] 0 0
From first treatment to 30 days after last treatment of study therapy including definitive surgery and radiotherapy (up to approximately 28 months)

Eligibility
Key inclusion criteria
* Participants with suspected or histologically confirmed Stage IIA (> 4 cm) to IIIB (T3N2) non-small cell lung carcinoma (NSCLC) with disease that is considered resectable
* No brain metastasis
* Treatment-naive for NSCLC (no prior systemic anti-cancer treatment)
* Ability to provide surgical or biopsy tumor tissue for biomarkers
* Eastern Cooperative Oncology Group (ECOG) Performance Status of = 1
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Participants with an active, known or suspected autoimmune disease
* Any positive test for hepatitis B virus or hepatitis C virus or human immunodeficiency virus (HIV)
* Any previous anti-cancer treatment including cytotoxic, IO treatment, targeted agents, or radiotherapy for NSCLC
* Prior treatment with any anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways

Other protocol-defined inclusion/exclusion criteria apply

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
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
5/11/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/07/2027
Actual
Sample size
Target
Accrual to date
Final
461
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Local Institution - 0020 - Sydney
Recruitment hospital [2] 0 0
Local Institution - 0033 - Heidelberg
Recruitment hospital [3] 0 0
Local Institution - 0122 - Melbourne
Recruitment hospital [4] 0 0
Local Institution - 0023 - North Ballarat
Recruitment postcode(s) [1] 0 0
2050 - Sydney
Recruitment postcode(s) [2] 0 0
3084 - Heidelberg
Recruitment postcode(s) [3] 0 0
3065 - Melbourne
Recruitment postcode(s) [4] 0 0
33500 - North Ballarat
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Maryland
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
New Hampshire
Country [8] 0 0
United States of America
State/province [8] 0 0
Ohio
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
United States of America
State/province [10] 0 0
Virginia
Country [11] 0 0
Argentina
State/province [11] 0 0
Buenos Aires
Country [12] 0 0
Argentina
State/province [12] 0 0
Ciudad Autónoma De Buenos Aires
Country [13] 0 0
Argentina
State/province [13] 0 0
Caba
Country [14] 0 0
Belgium
State/province [14] 0 0
Edegem
Country [15] 0 0
Belgium
State/province [15] 0 0
Liege
Country [16] 0 0
Belgium
State/province [16] 0 0
Roeselare
Country [17] 0 0
Brazil
State/province [17] 0 0
Minas Gerais
Country [18] 0 0
Brazil
State/province [18] 0 0
RIO Grande DO SUL
Country [19] 0 0
Brazil
State/province [19] 0 0
SAO Paulo
Country [20] 0 0
Brazil
State/province [20] 0 0
São Paulo
Country [21] 0 0
Canada
State/province [21] 0 0
Ontario
Country [22] 0 0
China
State/province [22] 0 0
Beijing
Country [23] 0 0
China
State/province [23] 0 0
BEI
Country [24] 0 0
China
State/province [24] 0 0
Fujian
Country [25] 0 0
China
State/province [25] 0 0
Hubei
Country [26] 0 0
China
State/province [26] 0 0
Hunan
Country [27] 0 0
China
State/province [27] 0 0
Shanghai
Country [28] 0 0
China
State/province [28] 0 0
Sichuan
Country [29] 0 0
China
State/province [29] 0 0
Zhejiang
Country [30] 0 0
Czechia
State/province [30] 0 0
Praha 2
Country [31] 0 0
Czechia
State/province [31] 0 0
Praha 4
Country [32] 0 0
France
State/province [32] 0 0
Besancon
Country [33] 0 0
France
State/province [33] 0 0
La Tronche
Country [34] 0 0
France
State/province [34] 0 0
Montpellier
Country [35] 0 0
France
State/province [35] 0 0
Paris Cedex 18
Country [36] 0 0
France
State/province [36] 0 0
Paris Cedex 20
Country [37] 0 0
France
State/province [37] 0 0
Rennes Cedex 9
Country [38] 0 0
France
State/province [38] 0 0
Rouen
Country [39] 0 0
Germany
State/province [39] 0 0
Nordrhein-Westfalen
Country [40] 0 0
Germany
State/province [40] 0 0
Berlin
Country [41] 0 0
Germany
State/province [41] 0 0
Frankfurt
Country [42] 0 0
Germany
State/province [42] 0 0
Georgsmarienhuette
Country [43] 0 0
Germany
State/province [43] 0 0
Hamm
Country [44] 0 0
Germany
State/province [44] 0 0
Heidelberg
Country [45] 0 0
Germany
State/province [45] 0 0
Immenstadt
Country [46] 0 0
Germany
State/province [46] 0 0
Loewenstein
Country [47] 0 0
Germany
State/province [47] 0 0
Ludwigsburg
Country [48] 0 0
Germany
State/province [48] 0 0
Luebeck
Country [49] 0 0
Germany
State/province [49] 0 0
Moers
Country [50] 0 0
Germany
State/province [50] 0 0
Muenchen
Country [51] 0 0
Ireland
State/province [51] 0 0
Dublin
Country [52] 0 0
Italy
State/province [52] 0 0
Forlì
Country [53] 0 0
Italy
State/province [53] 0 0
Milano
Country [54] 0 0
Italy
State/province [54] 0 0
Parma
Country [55] 0 0
Japan
State/province [55] 0 0
Aichi
Country [56] 0 0
Japan
State/province [56] 0 0
Chiba
Country [57] 0 0
Japan
State/province [57] 0 0
Fukuoka
Country [58] 0 0
Japan
State/province [58] 0 0
Hyogo
Country [59] 0 0
Japan
State/province [59] 0 0
Ishikawa
Country [60] 0 0
Japan
State/province [60] 0 0
Kanagawa
Country [61] 0 0
Japan
State/province [61] 0 0
Miyagi
Country [62] 0 0
Japan
State/province [62] 0 0
Osaka
Country [63] 0 0
Japan
State/province [63] 0 0
Saitama
Country [64] 0 0
Japan
State/province [64] 0 0
Tokyo
Country [65] 0 0
Japan
State/province [65] 0 0
Fukushima-shi
Country [66] 0 0
Japan
State/province [66] 0 0
Hiroshima
Country [67] 0 0
Mexico
State/province [67] 0 0
Jalisco
Country [68] 0 0
Mexico
State/province [68] 0 0
Nuevo Leon
Country [69] 0 0
Mexico
State/province [69] 0 0
Chihuahua
Country [70] 0 0
Netherlands
State/province [70] 0 0
Groningen
Country [71] 0 0
Netherlands
State/province [71] 0 0
Rotterdam
Country [72] 0 0
Poland
State/province [72] 0 0
Malopolskie
Country [73] 0 0
Puerto Rico
State/province [73] 0 0
Hato Rey
Country [74] 0 0
Romania
State/province [74] 0 0
Cluj
Country [75] 0 0
Romania
State/province [75] 0 0
Bucuresti
Country [76] 0 0
Romania
State/province [76] 0 0
Floresti
Country [77] 0 0
Russian Federation
State/province [77] 0 0
Moscow
Country [78] 0 0
Russian Federation
State/province [78] 0 0
Saint-Petersburg
Country [79] 0 0
Russian Federation
State/province [79] 0 0
St. Petersburg
Country [80] 0 0
Spain
State/province [80] 0 0
Madrid
Country [81] 0 0
Spain
State/province [81] 0 0
Majadahonda - Madrid
Country [82] 0 0
Spain
State/province [82] 0 0
Valencia
Country [83] 0 0
Taiwan
State/province [83] 0 0
Kaohsiung City
Country [84] 0 0
Taiwan
State/province [84] 0 0
Kaohsiung
Country [85] 0 0
Taiwan
State/province [85] 0 0
New Taipei City
Country [86] 0 0
Taiwan
State/province [86] 0 0
Taipei City
Country [87] 0 0
United Kingdom
State/province [87] 0 0
Taunton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT04025879