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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
342
0.9% sodium chloride injection, USP, or 5% dextrose injection
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.
Time frame: Approximately 43 months post study start
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.
Time frame: Approximately 43 months post study start
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.
Time frame: Approximately 43 months post study start
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Beijing, Beijing Municipality, China
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Beijing, Beijing Municipality, China
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Chongqing, Chongqing Municipality, China
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Fuzhou, Fujian, China
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Guangzhou, Guangdong, China
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Guangzhou, Guangdong, China
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Shantou, Guangdong, China
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...and 39 more locations