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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
The main purpose of the study is to examine if periadjuvant (neoadjuvant, then adjuvant) immunotherapy will prolong event free survival in participants with early stage non-small cell lung cancer.
Trial website
https://clinicaltrials.gov/study/NCT04025879
Trial related presentations / publications
Leal TA, Ramalingam SS. Neoadjuvant therapy gains FDA approval in non-small cell lung cancer. Cell Rep Med. 2022 Jul 19;3(7):100691. doi: 10.1016/j.xcrm.2022.100691.
Hong WX, Sagiv-Barfi I, Czerwinski DK, Sallets A, Levy R. Neoadjuvant Intratumoral Immunotherapy with TLR9 Activation and Anti-OX40 Antibody Eradicates Metastatic Cancer. Cancer Res. 2022 Apr 1;82(7):1396-1408. doi: 10.1158/0008-5472.CAN-21-1382.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04025879