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Phase 3 Trial in Squamous Non Small Cell Lung Cancer Subjects Comparing Ipilimumab Plus Paclitaxel and Carboplatin Versus Placebo Plus Paclitaxel and Carboplatin

Primary Purpose

Lung Cancer (NSCLC)

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Paclitaxel
Carboplatin
Ipilimumab
Placebo
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer (NSCLC)

Eligibility Criteria

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

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Subjects with NSCLC of predominantly squamous histology documented by histology or cytology from brushing, washing or needle aspiration of a defined lesion but not from sputum cytology alone
  • Stage IV or Recurrent NSCLC (per the 7th International Association for the Study of Lung Cancer (IASLC) classification)
  • At least 1 measurable tumor lesion, as defined by mWHO criteria, that is not located in a previously irradiated area
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤1

Exclusion Criteria:

  • Brain metastases
  • Malignant pleural effusion that is recurrent
  • Documented history of severe autoimmune or immune mediated symptomatic disease that required prolonged (more than 2 months) systemic immunosuppressive (ie, steroids) treatment

Sites / Locations

  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Pulmonologiai Klinika
  • Csongrad Megyei Onkormanyzat Mellkasi Betegsegek Szakkorhaza
  • Torokbalinti Tudogyogyintezet
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Oddzial Onkologiczny
  • Oddzial Chemioterapii
  • Klinika Nowotworow Pluca i Klatki Piersiowej
  • Local Institution
  • Local Institution

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm 1: Carboplatin + Paclitaxel + Ipilimumab

Arm 2: Carboplatin + Paclitaxel + Placebo

Arm Description

Paclitaxel 175 mg/m² IV Solution Every 3 weeks during induction and every 12 weeks during maintenance until disease progression declared by modified WHO (mWHO) Carboplatin Area Under the Curve (AUC6) IV Solution Every 3 weeks during induction and every 12 weeks during maintenance until disease progression declared by mWHO Ipilimumab 10 mg/kg IV Solution Every 3 weeks during induction and every 12 weeks during maintenance until disease progression declared by mWHO

Carboplatin AUC6 IV Solution Every 3 weeks during induction and every 12 weeks during maintenance until disease progression declared by mWHO Paclitaxel 175 mg/m² IV Solution Every 3 weeks during induction and every 12 weeks during maintenance until disease progression declared by mWHO Placebo IV Solution Every 3 weeks during induction and every 12 weeks during maintenance until disease progression declared by mWHO

Outcomes

Primary Outcome Measures

Overall Survival (OS) of All Randomized Participants Who Received at Least One Dose of Blinded Study Therapy
OS is defined as the time from the date of randomization until the date of death. For those participants who have not died, OS was censored on the last date the participant was known to be alive.

Secondary Outcome Measures

Overall Survival of All Randomized Participants
OS is defined as the time from the date of randomization until the date of death. For those participants who have not died, OS was censored on the last date the participant was known to be alive.
Progression-free Survival (PFS) Among All Randomized Particiapants Who Received at Least One Dose of Blinded Study Therapy Using Modified World Health Organization (mWHO) Criteria
PFS is defined as the time between the date of randomization and the date of progression per mWHO criteria or death, whichever occurs first. A participant who died without reported progression per mWHO criteria was considered to have progressed on the date of death. For those participants who remained alive and had not progressed, PFS was censored on the date of last evaluable tumor assessment. For those participants who remained alive and had no recorded post-baseline tumor assessment, PFS was censored on the day of randomization.

Full Information

First Posted
October 14, 2014
Last Updated
July 22, 2019
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT02279732
Brief Title
Phase 3 Trial in Squamous Non Small Cell Lung Cancer Subjects Comparing Ipilimumab Plus Paclitaxel and Carboplatin Versus Placebo Plus Paclitaxel and Carboplatin
Official Title
A Randomized, Multicenter, Double-Blind, Multinational, Phase 3 Trial Comparing the Efficacy of Ipilimumab in Addition to Paclitaxel and Carboplatin Versus Placebo in Addition to Paclitaxel and Carboplatin in Subjects With Stage IV/Recurrent Non-Small Cell Lung Cancer (NSCLC) With Squamous Histology
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
October 13, 2014 (Actual)
Primary Completion Date
May 3, 2018 (Actual)
Study Completion Date
May 3, 2018 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of the study is to determine whether Ipilimumab plus Paclitaxel and Carboplatin will extend the life of patients with squamous only non small cell lung cancer more than placebo plus Paclitaxel and Carboplatin.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer (NSCLC)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
342 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: Carboplatin + Paclitaxel + Ipilimumab
Arm Type
Experimental
Arm Description
Paclitaxel 175 mg/m² IV Solution Every 3 weeks during induction and every 12 weeks during maintenance until disease progression declared by modified WHO (mWHO) Carboplatin Area Under the Curve (AUC6) IV Solution Every 3 weeks during induction and every 12 weeks during maintenance until disease progression declared by mWHO Ipilimumab 10 mg/kg IV Solution Every 3 weeks during induction and every 12 weeks during maintenance until disease progression declared by mWHO
Arm Title
Arm 2: Carboplatin + Paclitaxel + Placebo
Arm Type
Experimental
Arm Description
Carboplatin AUC6 IV Solution Every 3 weeks during induction and every 12 weeks during maintenance until disease progression declared by mWHO Paclitaxel 175 mg/m² IV Solution Every 3 weeks during induction and every 12 weeks during maintenance until disease progression declared by mWHO Placebo IV Solution Every 3 weeks during induction and every 12 weeks during maintenance until disease progression declared by mWHO
Intervention Type
Biological
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
Taxol®, BMS-181339
Intervention Type
Biological
Intervention Name(s)
Carboplatin
Other Intervention Name(s)
Paraplatin®
Intervention Type
Biological
Intervention Name(s)
Ipilimumab
Other Intervention Name(s)
MDX-010, BMS-734016
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
0.9% sodium chloride injection, USP, or 5% dextrose injection
Primary Outcome Measure Information:
Title
Overall Survival (OS) of All Randomized Participants Who Received at Least One Dose of Blinded Study Therapy
Description
OS is defined as the time from the date of randomization until the date of death. For those participants who have not died, OS was censored on the last date the participant was known to be alive.
Time Frame
Approximately 43 months post study start
Secondary Outcome Measure Information:
Title
Overall Survival of All Randomized Participants
Description
OS is defined as the time from the date of randomization until the date of death. For those participants who have not died, OS was censored on the last date the participant was known to be alive.
Time Frame
Approximately 43 months post study start
Title
Progression-free Survival (PFS) Among All Randomized Particiapants Who Received at Least One Dose of Blinded Study Therapy Using Modified World Health Organization (mWHO) Criteria
Description
PFS is defined as the time between the date of randomization and the date of progression per mWHO criteria or death, whichever occurs first. A participant who died without reported progression per mWHO criteria was considered to have progressed on the date of death. For those participants who remained alive and had not progressed, PFS was censored on the date of last evaluable tumor assessment. For those participants who remained alive and had no recorded post-baseline tumor assessment, PFS was censored on the day of randomization.
Time Frame
Approximately 43 months post study start

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Subjects with NSCLC of predominantly squamous histology documented by histology or cytology from brushing, washing or needle aspiration of a defined lesion but not from sputum cytology alone Stage IV or Recurrent NSCLC (per the 7th International Association for the Study of Lung Cancer (IASLC) classification) At least 1 measurable tumor lesion, as defined by mWHO criteria, that is not located in a previously irradiated area Eastern Cooperative Oncology Group (ECOG) performance status ≤1 Exclusion Criteria: Brain metastases Malignant pleural effusion that is recurrent Documented history of severe autoimmune or immune mediated symptomatic disease that required prolonged (more than 2 months) systemic immunosuppressive (ie, steroids) treatment
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
Beijing
State/Province
Beijing
ZIP/Postal Code
100032
Country
China
Facility Name
Local Institution
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100042
Country
China
Facility Name
Local Institution
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400042
Country
China
Facility Name
Local Institution
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350025
Country
China
Facility Name
Local Institution
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Facility Name
Local Institution
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
Local Institution
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Facility Name
Local Institution
City
Shantou
State/Province
Guangdong
ZIP/Postal Code
515041
Country
China
Facility Name
Local Institution
City
Zhengzhou
State/Province
Henan
Country
China
Facility Name
Local Institution
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Facility Name
Local Institution
City
Changsha
State/Province
Hunan
Country
China
Facility Name
Local Institution
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Facility Name
Local Institution
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China
Facility Name
Local Institution
City
Chang Chun
State/Province
Jilin
ZIP/Postal Code
130012
Country
China
Facility Name
Local Institution
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Name
Local Institution
City
Xi'an
State/Province
Shan3xi
ZIP/Postal Code
710038
Country
China
Facility Name
Local Institution
City
Xi'an
State/Province
Shan3xi
ZIP/Postal Code
710061
Country
China
Facility Name
Local Institution
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Facility Name
Local Institution
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Local Institution
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Local Institution
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Facility Name
Local Institution
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Facility Name
Local Institution
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310016
Country
China
Facility Name
Local Institution
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Facility Name
Local Institution
City
Beijing
ZIP/Postal Code
100071
Country
China
Facility Name
Local Institution
City
Chongqing
ZIP/Postal Code
400038
Country
China
Facility Name
Local Institution
City
Fuzhou
Country
China
Facility Name
Local Institution
City
Kunming
Country
China
Facility Name
Local Institution
City
Shanghai
ZIP/Postal Code
200030
Country
China
Facility Name
Local Institution
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
Local Institution
City
Halle
ZIP/Postal Code
06120
Country
Germany
Facility Name
Local Institution
City
Hamburg
ZIP/Postal Code
21075
Country
Germany
Facility Name
Local Institution
City
Leipzig
ZIP/Postal Code
04357
Country
Germany
Facility Name
Local Institution
City
Loewenstein
ZIP/Postal Code
74245
Country
Germany
Facility Name
Local Institution
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Pulmonologiai Klinika
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
Facility Name
Csongrad Megyei Onkormanyzat Mellkasi Betegsegek Szakkorhaza
City
Deszk
ZIP/Postal Code
6772
Country
Hungary
Facility Name
Torokbalinti Tudogyogyintezet
City
Torokbalint
ZIP/Postal Code
2045
Country
Hungary
Facility Name
Local Institution
City
Cheongju-si
State/Province
Chungcheonbuk-do
ZIP/Postal Code
28644
Country
Korea, Republic of
Facility Name
Local Institution
City
Suwon-si
State/Province
Gyeonggi-do
ZIP/Postal Code
16499
Country
Korea, Republic of
Facility Name
Local Institution
City
Hwasun-gun
State/Province
Jeonnam
ZIP/Postal Code
58128
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
05368
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Oddzial Onkologiczny
City
Elblag
ZIP/Postal Code
82-300
Country
Poland
Facility Name
Oddzial Chemioterapii
City
Poznan
ZIP/Postal Code
60-569
Country
Poland
Facility Name
Klinika Nowotworow Pluca i Klatki Piersiowej
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Local Institution
City
Singapore
ZIP/Postal Code
169610
Country
Singapore
Facility Name
Local Institution
City
Singapore
ZIP/Postal Code
308433
Country
Singapore

12. IPD Sharing Statement

Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
http://bms.com/studyconnect/Pages/home.aspx
Description
BMS Clinical Trial Patient Recruiting

Learn more about this trial

Phase 3 Trial in Squamous Non Small Cell Lung Cancer Subjects Comparing Ipilimumab Plus Paclitaxel and Carboplatin Versus Placebo Plus Paclitaxel and Carboplatin

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