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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

Primary Purpose

Lung Cancer, Non-Small Cell Lung Cancer

Status
Withdrawn
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
BMS-986205
Nivolumab
Chemotherapy
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Inclusion Criteria:

  • 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

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

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Arm A

Arm B

Arm C

Arm Description

BMS-986205 and Nivolumab administered in combination

BMS-986205 and Nivolumab administered in combination with chemotherapy

Chemotherapy administered alone

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Overall survival (OS) measured by the time between the date of randomization and the date of death due to any cause
Number of treatment-related adverse events (AE)
Number of treatment-related serious adverse events

Full Information

First Posted
January 25, 2018
Last Updated
April 26, 2018
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT03417037
Brief 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
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Business objectives have changed.
Study Start Date
May 24, 2018 (Anticipated)
Primary Completion Date
April 25, 2021 (Anticipated)
Study Completion Date
August 20, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Non-Small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Experimental
Arm Description
BMS-986205 and Nivolumab administered in combination
Arm Title
Arm B
Arm Type
Experimental
Arm Description
BMS-986205 and Nivolumab administered in combination with chemotherapy
Arm Title
Arm C
Arm Type
Active Comparator
Arm Description
Chemotherapy administered alone
Intervention Type
Drug
Intervention Name(s)
BMS-986205
Intervention Description
Administered orally daily, 100 mg
Intervention Type
Biological
Intervention Name(s)
Nivolumab
Other Intervention Name(s)
Opdivo, BMS-936558
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Chemotherapy
Intervention Description
Platinum-based doublet chemotherapy
Primary Outcome Measure Information:
Title
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
Time Frame
24 months
Title
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
Time Frame
34 months
Secondary Outcome Measure Information:
Title
Overall survival (OS) measured by the time between the date of randomization and the date of death due to any cause
Time Frame
Approximately 5 years
Title
Number of treatment-related adverse events (AE)
Time Frame
Approximately 5 years
Title
Number of treatment-related serious adverse events
Time Frame
Approximately 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Local Institution
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33916
Country
United States
Facility Name
Local Institution
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Local Institution
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
Local Institution
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Local Institution
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Local Institution
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Local Institution
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Local Institution
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Local Institution
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Local Institution
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Local Institution
City
Bridgeton
State/Province
Missouri
ZIP/Postal Code
63044
Country
United States
Facility Name
Local Institution
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
Local Institution
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Local Institution
City
Gettysburg
State/Province
Pennsylvania
ZIP/Postal Code
17325
Country
United States
Facility Name
Local Institution
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Facility Name
Local Institution
City
Lebanon
State/Province
Tennessee
ZIP/Postal Code
37087
Country
United States
Facility Name
Local Institution
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Local Institution
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79430-0002
Country
United States
Facility Name
Local Institution
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Local Institution
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Local Institution
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Local Institution
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Facility Name
Local Institution
City
North Tamworth
ZIP/Postal Code
2340
Country
Australia
Facility Name
Local Institution
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Local Institution
City
Wels
ZIP/Postal Code
4600
Country
Austria
Facility Name
Local Institution
City
Ipatinga
State/Province
Minas Gerais
ZIP/Postal Code
35160-158
Country
Brazil
Facility Name
Local Institution
City
Jd. Petropolis-Londrina
State/Province
Parana
ZIP/Postal Code
86015-520
Country
Brazil
Facility Name
Local Institution
City
Centro-porto Alegre
State/Province
RIO Grande DO SUL
ZIP/Postal Code
90050-170
Country
Brazil
Facility Name
Local Institution
City
Ijui
State/Province
RIO Grande DO SUL
ZIP/Postal Code
98700-000
Country
Brazil
Facility Name
Local Institution
City
Porto Alegre
State/Province
RIO Grande DO SUL
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Local Institution
City
Barretos
State/Province
SAO Paulo
ZIP/Postal Code
14780-070
Country
Brazil
Facility Name
Local Institution
City
Morumbi
State/Province
SAO Paulo
ZIP/Postal Code
05652-900
Country
Brazil
Facility Name
Local Institution
City
Rio de Janeiro
ZIP/Postal Code
22793-080
Country
Brazil
Facility Name
Local Institution
City
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
Facility Name
Local Institution
City
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
Local Institution
City
Besancon
ZIP/Postal Code
25030
Country
France
Facility Name
Local Institution
City
La Tronche
ZIP/Postal Code
38700
Country
France
Facility Name
Local Institution
City
Paris Cedex 5
ZIP/Postal Code
75248
Country
France
Facility Name
Local Institution
City
Pessac cedex
ZIP/Postal Code
33604
Country
France
Facility Name
Local Institution
City
Pringy Cedex
ZIP/Postal Code
74374
Country
France
Facility Name
Local Institution
City
Rennes Cedex 9
ZIP/Postal Code
35033
Country
France
Facility Name
Local Institution
City
Saint Herblain
ZIP/Postal Code
44805
Country
France
Facility Name
Local Institution
City
Toulon
ZIP/Postal Code
83000
Country
France
Facility Name
Local Institution
City
Berlin
ZIP/Postal Code
14165
Country
Germany
Facility Name
Local Institution
City
Gauting
ZIP/Postal Code
82131
Country
Germany
Facility Name
Local Institution
City
Gera
ZIP/Postal Code
07548
Country
Germany
Facility Name
Local Institution
City
Gottingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Local Institution
City
Grosshansdorf
ZIP/Postal Code
22927
Country
Germany
Facility Name
Local Institution
City
Hamburg
ZIP/Postal Code
21075
Country
Germany
Facility Name
Local Institution
City
Heidelberg
ZIP/Postal Code
69126
Country
Germany
Facility Name
Local Institution
City
Oldenburg
ZIP/Postal Code
26121
Country
Germany
Facility Name
Local Institution
City
Paderborn
ZIP/Postal Code
33098
Country
Germany
Facility Name
Local Institution
City
Wiesbaden
ZIP/Postal Code
65199
Country
Germany
Facility Name
Local Institution
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
Local Institution
City
Athens
ZIP/Postal Code
18547
Country
Greece
Facility Name
Local Institution
City
Thessaloniki
ZIP/Postal Code
54 622
Country
Greece
Facility Name
Local Institution
City
Modena
ZIP/Postal Code
41100
Country
Italy
Facility Name
Local Institution
City
Monza (MB)
ZIP/Postal Code
20900
Country
Italy
Facility Name
Local Institution
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Local Institution
City
Perugia
ZIP/Postal Code
06132
Country
Italy
Facility Name
Local Institution
City
Ravenna
ZIP/Postal Code
48121
Country
Italy
Facility Name
Local Institution
City
Reggio Emilia
ZIP/Postal Code
42100
Country
Italy
Facility Name
Local Institution
City
Fukushima-shi
State/Province
Fukushima
ZIP/Postal Code
9601295
Country
Japan
Facility Name
Local Institution
City
Morioka-shi
State/Province
Iwate
ZIP/Postal Code
0208505
Country
Japan
Facility Name
Local Institution
City
Osaka-sayama-shi
State/Province
Osaka
ZIP/Postal Code
5898511
Country
Japan
Facility Name
Local Institution
City
Kitaadachi-gun
State/Province
Saitama
ZIP/Postal Code
362-0806
Country
Japan
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Local Institution
City
Merida
State/Province
Yucatan
ZIP/Postal Code
97070
Country
Mexico
Facility Name
Local Institution
City
A Coruna
State/Province
Galicia
ZIP/Postal Code
15006
Country
Spain
Facility Name
Local Institution
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Local Institution
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Local Institution
City
Majadahonda - Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Local Institution
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Local Institution
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Local Institution
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Local Institution
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Local Institution
City
Taipei
Country
Taiwan
Facility Name
Local Institution
City
?stanbul
ZIP/Postal Code
34890
Country
Turkey
Facility Name
Local Institution
City
Adana
ZIP/Postal Code
01250
Country
Turkey
Facility Name
Local Institution
City
Antalya
ZIP/Postal Code
07070
Country
Turkey
Facility Name
Local Institution
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey

12. IPD Sharing Statement

Links:
URL
http://bms.com/studyconnect/Pages/home.aspx
Description
BMS Clinical Trial Patient Recruiting

Learn more about this trial

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

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