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

Lung Cancer (NSCLC) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02279732
• Other study ID #: CA184-153
• Secondary ID: 2014-002604-25
• Status: Completed
• Phase: Phase 3
• Start date: October 13, 2014
• Est. completion date: May 3, 2018

Study information

• Verified date: July 2019
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 342
• Est. completion date: May 3, 2018
• Est. primary completion date: May 3, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer (NSCLC)
• Lung Neoplasms

Intervention

Biological:
• Paclitaxel

• Carboplatin

• Ipilimumab

Other:
• Placebo
0.9% sodium chloride injection, USP, or 5% dextrose injection

Locations

Country	Name	City	State
China	Local Institution	Beijing	Beijing
China	Local Institution	Beijing	Beijing
China	Local Institution	Beijing
China	Local Institution	Chang Chun	Jilin
China	Local Institution	Changchun	Jilin
China	Local Institution	Changsha	Hunan
China	Local Institution	Changsha	Hunan
China	Local Institution	Chengdu	Sichuan
China	Local Institution	Chongqing	Chongqing
China	Local Institution	Chongqing
China	Local Institution	Fuzhou
China	Local Institution	Fuzhou	Fujian
China	Local Institution	Guangzhou	Guangdong
China	Local Institution	Guangzhou	Guangdong
China	Local Institution	Guangzhou	Guangdong
China	Local Institution	Hangzhou	Zhejiang
China	Local Institution	Hangzhou	Zhejiang
China	Local Institution	Hangzhou	Zhejiang
China	Local Institution	Hangzhou	Zhejiang
China	Local Institution	Kunming
China	Local Institution	Nanjing	Jiangsu
China	Local Institution	Nanjing	Jiangsu
China	Local Institution	Shanghai
China	Local Institution	Shanghai	Shanghai
China	Local Institution	Shanghai	Shanghai
China	Local Institution	Shantou	Guangdong
China	Local Institution	Xi'an	Shan3xi
China	Local Institution	Xi'an	Shan3xi
China	Local Institution	Zhengzhou	Henan
Germany	Local Institution	Berlin
Germany	Local Institution	Halle
Germany	Local Institution	Hamburg
Germany	Local Institution	Leipzig
Germany	Local Institution	Loewenstein
Germany	Local Institution	Mainz
Hungary	Pulmonologiai Klinika	Budapest
Hungary	Csongrad Megyei Onkormanyzat Mellkasi Betegsegek Szakkorhaza	Deszk
Hungary	Torokbalinti Tudogyogyintezet	Torokbalint
Korea, Republic of	Local Institution	Cheongju-si	Chungcheonbuk-do
Korea, Republic of	Local Institution	Hwasun-gun	Jeonnam
Korea, Republic of	Local Institution	Seoul
Korea, Republic of	Local Institution	Seoul
Korea, Republic of	Local Institution	Seoul
Korea, Republic of	Local Institution	Suwon-si	Gyeonggi-do
Poland	Oddzial Onkologiczny	Elblag
Poland	Oddzial Chemioterapii	Poznan
Poland	Klinika Nowotworow Pluca i Klatki Piersiowej	Warszawa
Singapore	Local Institution	Singapore
Singapore	Local Institution	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

China,  Germany,  Hungary,  Korea, Republic of,  Poland,  Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Approximately 43 months post study start
Secondary	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.	Approximately 43 months post study start
Secondary	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.	Approximately 43 months post study start

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   Investigator Inquiry Form