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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
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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
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Secondary ID [1]
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2019-000262-38
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Secondary ID [2]
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CA209-77T
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Carcinoma, Non-Small-Cell Lung
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Condition category
Condition code
Cancer
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Lung - Non small cell
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Other
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Event-Free Survival (EFS) by BICR
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Assessment method [1]
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The length of time from randomization to any of the following events: progression of disease or worsening of disease precluding surgery, if surgery is attempted but gross resection is abandoned due to unresectable tumor or worsening of disease, progression or recurrence of disease after surgery, progression or recurrence of disease without surgery, or death due to any cause. Progression/recurrence will be assessed by BICR per RECIST 1.1. Participants who do not undergo surgery for reason other than progression will be considered to have an event at RECIST 1.1 progression or death
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Timepoint [1]
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From randomization to disease progression, worsening, recurrence, or death due to any cause (up to approximately 44 months)
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Secondary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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OS is defined as the time between the date of randomization and the date of death due to any cause. OS will be censored on the last date a subject was known to be alive.
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Timepoint [1]
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From randomization and the date of death due to any cause.
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Secondary outcome [2]
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Pathologic Complete Response (pCR) Rate
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Assessment method [2]
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Pathologic complete response (pCR) rate is defined as the percentage of randomized participants with absence of residual viable tumor in lung and lymph nodes as evaluated by blinded independent pathology review (BIPR).
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Timepoint [2]
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From randomization up to approximately 44 months
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Secondary outcome [3]
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Major Pathological Response (MPR) Rate
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Assessment method [3]
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Major pathological response (MPR) rate is defined as the percentage of randomized participants with =10% residual viable tumor in lung and lymph nodes as evaluated by blinded independent pathology review (BIPR).
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Timepoint [3]
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From randomization up to approximately 44 months
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Secondary outcome [4]
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The Number of Participants With Adverse Events (AEs)
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Assessment method [4]
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An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
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Timepoint [4]
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From first treatment to 30 days after last treatment of study therapy including definitive surgery and radiotherapy (up to approximately 28 months)
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Secondary outcome [5]
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The Number of Participants With Serious Adverse Events (SAEs)
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Assessment method [5]
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Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event.
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Timepoint [5]
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From first treatment to 30 days after last treatment of study therapy including definitive surgery and radiotherapy (up to approximately 28 months)
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Secondary outcome [6]
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The Number of Participants With Select Adverse Events (AEs)
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Assessment method [6]
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An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
Select AEs include endocrinopathies, diarrhea/colitis, hepatitis, pneumonitis, interstitial nephritis, and rash. Multiple event terms that may describe each of these were grouped into endocrine, GI, hepatic, pulmonary, renal, and skin select AE categories, respectively. Hypersensitivity/infusion reactions were analyzed along with the select AE categories.
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Timepoint [6]
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From first treatment to 30 days after last treatment of study therapy including definitive surgery and radiotherapy (up to approximately 28 months)
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
5/11/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/07/2027
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Actual
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Sample size
Target
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Accrual to date
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Final
461
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Local Institution - 0020 - Sydney
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Recruitment hospital [2]
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Local Institution - 0033 - Heidelberg
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Recruitment hospital [3]
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Local Institution - 0122 - Melbourne
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Recruitment hospital [4]
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Local Institution - 0023 - North Ballarat
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Recruitment postcode(s) [1]
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2050 - Sydney
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Recruitment postcode(s) [2]
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3084 - Heidelberg
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Recruitment postcode(s) [3]
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3065 - Melbourne
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Recruitment postcode(s) [4]
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33500 - North Ballarat
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Recruitment outside Australia
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Florida
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Ciudad Autónoma De Buenos Aires
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Caba
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Brazil
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Brazil
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BEI
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Floresti
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Majadahonda - Madrid
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Valencia
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United Kingdom
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Taunton
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Bristol-Myers Squibb
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Address
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT04025879
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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.
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Public notes
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Contacts
Principal investigator
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Bristol-Myers Squibb
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Address
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Bristol-Myers Squibb
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/79/NCT04025879/Prot_SAP_000.pdf
Statistical analysis plan
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/79/NCT04025879/Prot_SAP_000.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04025879
Download to PDF