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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03417037




Registration number
NCT03417037
Ethics application status
Date submitted
25/01/2018
Date registered
31/01/2018
Date last updated
30/04/2018

Titles & IDs
Public title
An Immuno-Therapy Study of Experimental Medication BMS-986205 Given With Nivolumab With or Without Chemotherapy Compared to Chemotherapy in Participants With Previously Untreated Stage IV or Recurrent Non-Small Cell Lung Cancer
Scientific title
A Phase 3 Open Label, Randomized Study of BMS-986205 Combined With Nivolumab With or Without Chemotherapy Versus Chemotherapy in Participants With Previously Untreated Stage IV or Recurrent Non-Small Cell Lung Cancer
Secondary ID [1] 0 0
2017-003058-18
Secondary ID [2] 0 0
CA017-062
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BMS-986205
Treatment: Other - Nivolumab
Treatment: Drugs - Chemotherapy

Experimental: Arm A - BMS-986205 and Nivolumab administered in combination

Experimental: Arm B - BMS-986205 and Nivolumab administered in combination with chemotherapy

Active comparator: Arm C - Chemotherapy administered alone


Treatment: Drugs: BMS-986205
Administered orally daily, 100 mg

Treatment: Other: Nivolumab
Specified dose on specified days

Treatment: Drugs: Chemotherapy
Platinum-based doublet chemotherapy
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective response rate (ORR) measured by number of participants with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR) divided by the number of randomized participants for each treatment group
Timepoint [1] 0 0
24 months
Primary outcome [2] 0 0
Progression free survival (PFS) measured by the time between the date of randomization and the first date of documented progression, as determined by the Blinded Independent Central Review, or death, due to any cause, whichever occurs first
Timepoint [2] 0 0
34 months
Secondary outcome [1] 0 0
Overall survival (OS) measured by the time between the date of randomization and the date of death due to any cause
Timepoint [1] 0 0
Approximately 5 years
Secondary outcome [2] 0 0
Number of treatment-related adverse events (AE)
Timepoint [2] 0 0
Approximately 5 years
Secondary outcome [3] 0 0
Number of treatment-related serious adverse events
Timepoint [3] 0 0
Approximately 5 years

Eligibility
Key inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com



* Histologically confirmed stage IV NSCLC per the 8th IASLC of squamous or nonsquamous histology
* Locally advanced disease with recurrence after chemoradiation therapy (stage IIIB disease, specifically refers to patients with no curative treatment options)
* No prior systemic anti-cancer therapy (including EGFR and ALK/ROS1 inhibitors) given as primary therapy for advanced or metastatic disease
* Participants must have biomarker test results available for randomization
* ECOG Performance Status of = 1
* Measurable disease by CT or MRI per RECIST 1.1 criteria
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Participants with known sensitizing EGFR mutations or known ALK/ROS1 rearrangements
* Participants with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity
* Participants with an active, known or suspected autoimmune disease [Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll]
* Participants with untreated CNS metastases are excluded [Participants are eligible if CNS metastases are adequately treated and participants are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to first treatment]

Other protocol defined inclusion/exclusion criteria could 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
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
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
24/05/2018
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
20/08/2025
Actual
Sample size
Target
Accrual to date
Final
0
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - Darlinghurst
Recruitment hospital [2] 0 0
Local Institution - Brisbane
Recruitment hospital [3] 0 0
Local Institution - Melbourne
Recruitment hospital [4] 0 0
Local Institution - Murdoch
Recruitment hospital [5] 0 0
Local Institution - North Tamworth
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
4102 - Brisbane
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment postcode(s) [4] 0 0
6150 - Murdoch
Recruitment postcode(s) [5] 0 0
2340 - North Tamworth
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
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Kansas
Country [5] 0 0
United States of America
State/province [5] 0 0
Kentucky
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
Nebraska
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Pennsylvania
Country [11] 0 0
United States of America
State/province [11] 0 0
South Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Tennessee
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
Austria
State/province [14] 0 0
Vienna
Country [15] 0 0
Austria
State/province [15] 0 0
Wels
Country [16] 0 0
Brazil
State/province [16] 0 0
Minas Gerais
Country [17] 0 0
Brazil
State/province [17] 0 0
Parana
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
Rio de Janeiro
Country [21] 0 0
Canada
State/province [21] 0 0
Quebec
Country [22] 0 0
Czechia
State/province [22] 0 0
Praha 2
Country [23] 0 0
France
State/province [23] 0 0
Besancon
Country [24] 0 0
France
State/province [24] 0 0
La Tronche
Country [25] 0 0
France
State/province [25] 0 0
Paris Cedex 5
Country [26] 0 0
France
State/province [26] 0 0
Pessac cedex
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France
State/province [27] 0 0
Pringy Cedex
Country [28] 0 0
France
State/province [28] 0 0
Rennes Cedex 9
Country [29] 0 0
France
State/province [29] 0 0
Saint Herblain
Country [30] 0 0
France
State/province [30] 0 0
Toulon
Country [31] 0 0
Germany
State/province [31] 0 0
Berlin
Country [32] 0 0
Germany
State/province [32] 0 0
Gauting
Country [33] 0 0
Germany
State/province [33] 0 0
Gera
Country [34] 0 0
Germany
State/province [34] 0 0
Gottingen
Country [35] 0 0
Germany
State/province [35] 0 0
Grosshansdorf
Country [36] 0 0
Germany
State/province [36] 0 0
Hamburg
Country [37] 0 0
Germany
State/province [37] 0 0
Heidelberg
Country [38] 0 0
Germany
State/province [38] 0 0
Oldenburg
Country [39] 0 0
Germany
State/province [39] 0 0
Paderborn
Country [40] 0 0
Germany
State/province [40] 0 0
Wiesbaden
Country [41] 0 0
Greece
State/province [41] 0 0
Athens
Country [42] 0 0
Greece
State/province [42] 0 0
Thessaloniki
Country [43] 0 0
Italy
State/province [43] 0 0
Modena
Country [44] 0 0
Italy
State/province [44] 0 0
Monza (MB)
Country [45] 0 0
Italy
State/province [45] 0 0
Napoli
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Italy
State/province [46] 0 0
Perugia
Country [47] 0 0
Italy
State/province [47] 0 0
Ravenna
Country [48] 0 0
Italy
State/province [48] 0 0
Reggio Emilia
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Japan
State/province [49] 0 0
Fukushima
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Japan
State/province [50] 0 0
Iwate
Country [51] 0 0
Japan
State/province [51] 0 0
Osaka
Country [52] 0 0
Japan
State/province [52] 0 0
Saitama
Country [53] 0 0
Korea, Republic of
State/province [53] 0 0
Seoul
Country [54] 0 0
Mexico
State/province [54] 0 0
Yucatan
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Spain
State/province [55] 0 0
Galicia
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Spain
State/province [56] 0 0
Barcelona
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Spain
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Madrid
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Spain
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Majadahonda - Madrid
Country [59] 0 0
Spain
State/province [59] 0 0
Malaga
Country [60] 0 0
Spain
State/province [60] 0 0
Valencia
Country [61] 0 0
Switzerland
State/province [61] 0 0
Basel
Country [62] 0 0
Taiwan
State/province [62] 0 0
Taipei
Country [63] 0 0
Turkey
State/province [63] 0 0
?stanbul
Country [64] 0 0
Turkey
State/province [64] 0 0
Adana
Country [65] 0 0
Turkey
State/province [65] 0 0
Antalya
Country [66] 0 0
Turkey
State/province [66] 0 0
Istanbul

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

Ethics approval
Ethics application status

Summary
Brief summary
This is a study of experimental medication BMS-986205 given with Nivolumab with or without chemotherapy compared to chemotherapy in participants with previously untreated stage IV or recurrent non-small cell lung cancer.
Trial website
https://clinicaltrials.gov/study/NCT03417037
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03417037