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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04025879
Registration number
NCT04025879
Ethics application status
Date submitted
17/07/2019
Date registered
19/07/2019
Date last updated
8/04/2024
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
Other interventions - 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. -
Other interventions: 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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Other interventions
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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) as Assessed by Blinded Independent Central Review (BICR)
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Assessment method [1]
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Timepoint [1]
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5 Years from randomization
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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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Timepoint [1]
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Up to 5 years from randomization
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Secondary outcome [2]
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Pathologic Complete Response (pCR) Rate as Assessed by Blinded Independent Pathology Review (BIPR)
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Assessment method [2]
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Timepoint [2]
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At the time of surgery, between week 12 to week 18
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Secondary outcome [3]
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Major Pathological Response (MPR) Rate as Assessed by Blinded Independent Pathology Review
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Assessment method [3]
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Timepoint [3]
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Up to 8 weeks following completion of neoadjuvant surgery, approximately study week 22
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Secondary outcome [4]
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Incidence of Serious Adverse Events (SAEs)
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Assessment method [4]
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Timepoint [4]
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Up to 80 weeks
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Secondary outcome [5]
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Incidence of Adverse Events (AEs)
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Assessment method [5]
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Timepoint [5]
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Up to 80 weeks
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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
30/09/2024
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Actual
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Sample size
Target
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Accrual to date
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Final
482
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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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United States of America
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Florida
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Buenos Aires
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Argentina
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Ciudad Autónoma De Buenos Aires
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Caba
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Edegem
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Liege
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Belgium
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Roeselare
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Brazil
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Brazil
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SAO Paulo
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Brazil
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Beijing
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China
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BEI
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Fujian
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China
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France
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France
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France
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France
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Georgsmarienhuette
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Germany
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Hamm
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Germany
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Heidelberg
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Germany
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Germany
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Moers
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Mexico
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Chihuahua
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Groningen
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Hato Rey
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Cluj
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Romania
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Bucuresti
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Floresti
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Russian Federation
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Moscow
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Russian Federation
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Saint-Petersburg
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Russian Federation
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St. Petersburg
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Spain
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Madrid
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Spain
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Majadahonda - Madrid
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Spain
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Valencia
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Taiwan
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Kaohsiung City
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Taiwan
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Kaohsiung
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Taiwan
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New Taipei City
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Taiwan
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Taipei City
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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/ct2/show/NCT04025879
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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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
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04025879
Download to PDF