Clinical trial NCT02279732: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lung Cancer (NSCLC)
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2014-10-31
Enrollment: 342
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Overall Survival (OS) of All Randomized Participants Who Received at Least One Dose of Blinded Study Therapy
timeFrame: Approximately 43 months post study start
Secondary outcomes:
measure: Overall Survival of All Randomized Participants
timeFrame: Approximately 43 months post study start
measure: 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
timeFrame: Approximately 43 months post study start
Other outcomes:
Locations:
city: Beijing
country: China
facility: Local Institution
state: Beijing
city: Beijing
country: China
facility: Local Institution
state: Beijing
city: Chongqing
country: China
facility: Local Institution
state: Chongqing
city: Fuzhou
country: China
facility: Local Institution
state: Fujian
city: Guangzhou
country: China
facility: Local Institution
state: Guangdong
city: Guangzhou
country: China
facility: Local Institution
state: Guangdong
city: Guangzhou
country: China
facility: Local Institution
state: Guangdong
city: Shantou
country: China
facility: Local Institution
state: Guangdong
city: Zhengzhou
country: China
facility: Local Institution
state: Henan
city: Changsha
country: China
facility: Local Institution
state: Hunan
city: Changsha
country: China
facility: Local Institution
state: Hunan
city: Nanjing
country: China
facility: Local Institution
state: Jiangsu
city: Nanjing
country: China
facility: Local Institution
state: Jiangsu
city: Chang Chun
country: China
facility: Local Institution
state: Jilin
city: Changchun
country: China
facility: Local Institution
state: Jilin
city: Xi'an
country: China
facility: Local Institution
state: Shan3xi
city: Xi'an
country: China
facility: Local Institution
state: Shan3xi
city: Shanghai
country: China
facility: Local Institution
state: Shanghai
city: Shanghai
country: China
facility: Local Institution
state: Shanghai
city: Chengdu
country: China
facility: Local Institution
state: Sichuan
city: Hangzhou
country: China
facility: Local Institution
state: Zhejiang
city: Hangzhou
country: China
facility: Local Institution
state: Zhejiang
city: Hangzhou
country: China
facility: Local Institution
state: Zhejiang
city: Hangzhou
country: China
facility: Local Institution
state: Zhejiang
city: Beijing
country: China
facility: Local Institution
city: Chongqing
country: China
facility: Local Institution
city: Fuzhou
country: China
facility: Local Institution
city: Kunming
country: China
facility: Local Institution
city: Shanghai
country: China
facility: Local Institution
city: Berlin
country: Germany
facility: Local Institution
city: Halle
country: Germany
facility: Local Institution
city: Hamburg
country: Germany
facility: Local Institution
city: Leipzig
country: Germany
facility: Local Institution
city: Loewenstein
country: Germany
facility: Local Institution
city: Mainz
country: Germany
facility: Local Institution
city: Budapest
country: Hungary
facility: Pulmonologiai Klinika
city: Deszk
country: Hungary
facility: Csongrad Megyei Onkormanyzat Mellkasi Betegsegek Szakkorhaza
city: Torokbalint
country: Hungary
facility: Torokbalinti Tudogyogyintezet
city: Cheongju-si
country: Korea, Republic of
facility: Local Institution
state: Chungcheonbuk-do
city: Suwon-si
country: Korea, Republic of
facility: Local Institution
state: Gyeonggi-do
city: Hwasun-gun
country: Korea, Republic of
facility: Local Institution
state: Jeonnam
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Elblag
country: Poland
facility: Oddzial Onkologiczny
city: Poznan
country: Poland
facility: Oddzial Chemioterapii
city: Warszawa
country: Poland
facility: Klinika Nowotworow Pluca i Klatki Piersiowej
city: Singapore
country: Singapore
facility: Local Institution
city: Singapore
country: Singapore
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: