Trial Outcomes & Findings for Phase II Study for Previously Untreated Subjects With Non Small Cell Lung Cancer (NSCLC) or Small Cell Lung Cancer (SCLC) (NCT NCT00527735)

Last Updated: 2018-07-18

Results Overview

irPFS is defined as the time between the randomization date and date of immune-related Progressive Disease (irPD) (at least 25% increase percentage change in total tumor burden, including new lesions) or death, whichever occurs first. For patients with no recorded postbaseline tumor assessments, irPFS is censored at randomization. Participant who die without reported irPD are considered to have progressed on the date of death. For those who remain alive and have no irPD, irPFS is censored on the date of last evaluable tumor assessment. Independent review committee performed tumor assessment.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

334 participants

Primary outcome timeframe

Tumor assessed at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance until immune-related Progressive Disease (irPD) or death (of censored, maximum reached: 16.5 months)

Results posted on

2018-07-18

Participant Flow

Of 334 participants enrolled in this study, 331 received treatment. One patient with nonsmall-cell lung cancer, randomized to the sequential arm but mistakenly treated with concurrent therapy, is included in the sequential arm for efficacy results and in the concurrent arm for safety results.

Participant milestones

Participant milestones
Measure	Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered intravenously (IV) as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until progressive disease (PD), drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.	Ipilimumab + Paclitaxel/Carboplatin (Sequential) During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.	Placebo + Paclitaxel/Carboplatin During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
Overall Study STARTED	113	109	109
Overall Study COMPLETED	5	2	2
Overall Study NOT COMPLETED	108	107	107

Reasons for withdrawal

Reasons for withdrawal
Measure	Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered intravenously (IV) as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until progressive disease (PD), drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.	Ipilimumab + Paclitaxel/Carboplatin (Sequential) During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.	Placebo + Paclitaxel/Carboplatin During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
Overall Study Disease progression	47	61	53
Overall Study Death	23	13	15
Overall Study Completed treatment in treatment phase	14	13	18
Overall Study Adverse Event	10	6	7
Overall Study Not identified	5	5	5
Overall Study Withdrawal by Subject	5	4	3
Overall Study No longer met study criteria	2	2	1
Overall Study Lost to Follow-up	0	0	3
Overall Study Poor compliance or noncompliance	0	1	1
Overall Study Completed treatment during maintenance	2	2	1

Baseline Characteristics

Phase II Study for Previously Untreated Subjects With Non Small Cell Lung Cancer (NSCLC) or Small Cell Lung Cancer (SCLC)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) n=113 Participants During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin (concurrent). The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered intravenously (IV) as a single dose over 90 minutes every 3 weeks. Participants who experienced clinical benefit on treatment phase without intolerable toxicity were allowed to continue in the maintenance phase, receiving additional ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until immune-related progressive disease (irPD), drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.	Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential) n=110 Participants During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin (sequential). The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes every 3 weeks. Participants who experienced clinical benefit on treatment phase without intolerable toxicity were allowed to continue in the maintenance phase, receiving additional ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.	Placebo + Paclitaxel/Carboplatin n=111 Participants During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who experienced clinical benefit on treatment phase without intolerable toxicity could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.	Total n=334 Participants Total of all reporting groups
Age, Customized Younger than 65 years	79 Participants n=5 Participants	73 Participants n=7 Participants	76 Participants n=5 Participants	228 Participants n=4 Participants
Age, Customized 65 years and older	34 Participants n=5 Participants	37 Participants n=7 Participants	35 Participants n=5 Participants	106 Participants n=4 Participants
Sex: Female, Male Female	27 Participants n=5 Participants	29 Participants n=7 Participants	29 Participants n=5 Participants	85 Participants n=4 Participants
Sex: Female, Male Male	86 Participants n=5 Participants	81 Participants n=7 Participants	82 Participants n=5 Participants	249 Participants n=4 Participants
Age Customized, by Disease Type Younger than 65 years (NSCLC patients)	44 Participants n=5 Participants	44 Participants n=7 Participants	40 Participants n=5 Participants	128 Participants n=4 Participants
Age Customized, by Disease Type 65 years and older (NSCLC patients)	26 Participants n=5 Participants	24 Participants n=7 Participants	26 Participants n=5 Participants	76 Participants n=4 Participants
Age Customized, by Disease Type Younger than 65 years (SCLC patients)	35 Participants n=5 Participants	29 Participants n=7 Participants	36 Participants n=5 Participants	100 Participants n=4 Participants
Age Customized, by Disease Type 65 years and older (SCLC patients)	8 Participants n=5 Participants	13 Participants n=7 Participants	9 Participants n=5 Participants	30 Participants n=4 Participants
Gender, by Disease Type Female (NSCLC patients)	17 Participants n=5 Participants	19 Participants n=7 Participants	17 Participants n=5 Participants	53 Participants n=4 Participants
Gender, by Disease Type Male (NSCLC patients)	53 Participants n=5 Participants	49 Participants n=7 Participants	49 Participants n=5 Participants	151 Participants n=4 Participants
Gender, by Disease Type Female (SCLC patients)	10 Participants n=5 Participants	10 Participants n=7 Participants	12 Participants n=5 Participants	32 Participants n=4 Participants
Gender, by Disease Type Male (SCLC patients)	33 Participants n=5 Participants	32 Participants n=7 Participants	33 Participants n=5 Participants	98 Participants n=4 Participants
Disease Stage at Study Entry Stage IIIB (NSCLC patients)	11 Participants n=5 Participants	7 Participants n=7 Participants	17 Participants n=5 Participants	35 Participants n=4 Participants
Disease Stage at Study Entry Stage IV (NSCLC patients)	59 Participants n=5 Participants	61 Participants n=7 Participants	49 Participants n=5 Participants	169 Participants n=4 Participants
Disease Stage at Study Entry Extensive (SCLC patients)	43 Participants n=5 Participants	42 Participants n=7 Participants	44 Participants n=5 Participants	129 Participants n=4 Participants
Disease Stage at Study Entry Recurrent disease (SCLC patients)	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Cell Type Adenocarcinoma (NSCLC patients)	35 Participants n=5 Participants	30 Participants n=7 Participants	38 Participants n=5 Participants	103 Participants n=4 Participants
Cell Type Bronchoalveolar carcinoma (NSCLC patients)	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Cell Type Large-cell carcinoma (NSCLC patients)	6 Participants n=5 Participants	11 Participants n=7 Participants	7 Participants n=5 Participants	24 Participants n=4 Participants
Cell Type Other (NSCLC patients)	6 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	13 Participants n=4 Participants
Cell Type Squamous-cell carcinoma (NSCLC patients)	21 Participants n=5 Participants	21 Participants n=7 Participants	15 Participants n=5 Participants	57 Participants n=4 Participants
Cell Type Unknown (NSCLC patients)	1 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	5 Participants n=4 Participants
Cell Type Other (SCLC patients)	2 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants
Cell Type Small-cell carcinoma (SCLC patients)	41 Participants n=5 Participants	38 Participants n=7 Participants	45 Participants n=5 Participants	124 Participants n=4 Participants
Cell Type Unknown (SCLC patients)	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Cell Type Not reported (SCLC patients)	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants

PRIMARY outcome

Timeframe: Tumor assessed at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance until immune-related Progressive Disease (irPD) or death (of censored, maximum reached: 16.5 months)

Population: All participants with NSCLC who were randomized to a treatment group.

Outcome measures

Outcome measures
Measure	Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) n=70 Participants During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered intravenously (IV) as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until immune-related progressive disease (irPD), drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.	Ipilimumab + Paclitaxel/Carboplatin (Sequential) n=68 Participants During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.	Placebo + Paclitaxel/Carboplatin n=66 Participants During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
Immune-related Progression-free Survival (irPFS) in Participants With Nonsmall-cell Lung Cancer (NSCLC) Per Immune-related Response Criteria (irRC)	5.52 Months Interval 4.17 to 6.74	5.68 Months Interval 4.76 to 7.79	4.63 Months Interval 4.14 to 5.52

SECONDARY outcome

Timeframe: Randomization date to date of progression or death (of censored, maximum reached: 13.6 months)

Population: All NSCLC participants who were randomized to a treatment group.

By mWHO criteria, PFS is defined as the time between the randomization date and the date of progression or death, whichever occurs first. For participants with no recorded postbaseline tumor assessment, PFS was censored at the day of randomization. A participant who died without reported prior progression was considered to have progressed on the date of death. For those who remain alive and have not progressed, PFS was censored on the date of last evaluable tumor assessment. Independent review committee performed tumor assessment.

Outcome measures

Outcome measures
Measure	Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) n=70 Participants During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered intravenously (IV) as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until immune-related progressive disease (irPD), drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.	Ipilimumab + Paclitaxel/Carboplatin (Sequential) n=68 Participants During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.	Placebo + Paclitaxel/Carboplatin n=66 Participants During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
Progression-free Survival (PFS) in Participants With NSCLC Per Modified World Health Organization (mWHO) Criteria	4.11 Months Interval 2.76 to 5.32	5.13 Months Interval 4.17 to 5.72	4.21 Months Interval 2.76 to 5.32

SECONDARY outcome

Timeframe: Randomization date to date of death (of censored, maximum reached: 26.5 months)

Population: All NSCLC participants who were randomized to a treatment group.

Overall Survival is defined as the time from the date of randomization until the date of death. For participants who have not died, Overall Survival was censored at the recorded last date of contact; participants with a missing recorded last date of contact were censored at the last date the participant was known to be alive.

Outcome measures

Outcome measures
Measure	Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) n=70 Participants During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered intravenously (IV) as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until immune-related progressive disease (irPD), drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.	Ipilimumab + Paclitaxel/Carboplatin (Sequential) n=68 Participants During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.	Placebo + Paclitaxel/Carboplatin n=66 Participants During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
Overall Survival in Participants With NSCLC	9.69 Months Interval 7.59 to 12.48	12.22 Months Interval 9.26 to 14.39	8.28 Months Interval 6.8 to 12.39

SECONDARY outcome

Timeframe: Tumor assessment at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance

Population: All participants who were randomized to a treatment group.

mWHO criteria define BORR as the number of patients with best overall response of Complete Response (CR) or Partial Response (PR), divided by the total number of participants in the data set (multiplied by 100 for percentage). CR=Complete disappearance of all index lesions; PR=decrease from baseline of \>=50% in the sum of products of the 2 largest perpendicular diameters of all index lesions. Independent review committee performed tumor assessment.

Outcome measures

Outcome measures
Measure	Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) n=113 Participants During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered intravenously (IV) as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until immune-related progressive disease (irPD), drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.	Ipilimumab + Paclitaxel/Carboplatin (Sequential) n=110 Participants During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.	Placebo + Paclitaxel/Carboplatin n=111 Participants During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
Best Overall Response Rate (BORR) Per mWHO Criteria in Participants With NSCLC and SCLC BORR (mWHO criteria) NSCLC cohort (n=70, 68, 66)	21.4 Percentage of participants Interval 12.5 to 32.29	32.4 Percentage of participants Interval 21.5 to 44.8	13.6 Percentage of participants Interval 6.4 to 24.3
Best Overall Response Rate (BORR) Per mWHO Criteria in Participants With NSCLC and SCLC BORR (mWHO criteria) SCLC cohort (n=43, 42, 45)	32.6 Percentage of participants Interval 19.1 to 48.5	57.1 Percentage of participants Interval 41.0 to 72.3	48.9 Percentage of participants Interval 33.7 to 64.2

SECONDARY outcome

Timeframe: Tumor assessment at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance

Population: All participants who were randomized to a treatment group.

irBORR=number of participants with irBORR of immune-related Complete Response (irCR) or immune-related Partial Response (irPR), divided by total participants in the data set. irCR=Complete disappearance of all index lesions. irPR=Decrease, relative to baseline, of 50% or greater in the sum of the products of the 2 largest perpendicular diameters of all index and of all new measurable lesions. Independent review committee performed the tumor assessments.

Outcome measures

Outcome measures
Measure	Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) n=113 Participants During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered intravenously (IV) as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until immune-related progressive disease (irPD), drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.	Ipilimumab + Paclitaxel/Carboplatin (Sequential) n=110 Participants During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.	Placebo + Paclitaxel/Carboplatin n=111 Participants During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
Immune-related Best Overall Response Rate (irBORR) Per irRC in Participants With NSCLC and Small-cell Lung Cancer (SCLC) irBORR ( irRC) NSCLC cohort (n=70, 68, 66)	21.4 Percentage of participants Interval 12.5 to 32.29	32.4 Percentage of participants Interval 21.5 to 44.8	18.2 Percentage of participants Interval 9.8 to 29.6
Immune-related Best Overall Response Rate (irBORR) Per irRC in Participants With NSCLC and Small-cell Lung Cancer (SCLC) irBORR (irRC) SCLC cohort (n=43, 42, 45)	48.8 Percentage of participants Interval 33.3 to 64.5	71.4 Percentage of participants Interval 55.4 to 84.3	53.3 Percentage of participants Interval 37.9 to 68.3

SECONDARY outcome

Timeframe: Tumor assessment at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance until irPD, progressive disease, or death (maximum reached: 22 months)

Population: All participants who were randomized to a treatment group.

irDCR is defined as the proportion of participants whose immune-related best overall response is irPR, irCR, or immune-related Stable Disease (irSD) in the analysis data set. irSD=Does not meet criteria for irCR or irPR, in the absence of progressive disease. By mWHO criteria, DCR is defined as the proportion of participants whose best overall response is PR, CR, or SD in the analysis data set. SD=A decrease or tumor stabilization of 1 or more nonindex lesions. Independent review committee assessed response.

Outcome measures

Outcome measures
Measure	Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) n=113 Participants During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered intravenously (IV) as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until immune-related progressive disease (irPD), drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.	Ipilimumab + Paclitaxel/Carboplatin (Sequential) n=110 Participants During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.	Placebo + Paclitaxel/Carboplatin n=111 Participants During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
Immune-related Disease Control Rate (irDCR) Per irRC and Disease Control Rate (DCR) Per mWHO Criteria in Participants With NSCLC and SCLC irDCR (irRC) NSCLC cohort (n=70, 68, 66)	70.0 Percent of participants Interval 57.9 to 80.4	86.8 Percent of participants Interval 76.4 to 93.8	81.8 Percent of participants Interval 70.4 to 90.2
Immune-related Disease Control Rate (irDCR) Per irRC and Disease Control Rate (DCR) Per mWHO Criteria in Participants With NSCLC and SCLC DCR (mWHO criteria) NSCLC cohort (n=70, 68, 66)	57.1 Percent of participants Interval 44.7 to 68.9	77.9 Percent of participants Interval 66.2 to 87.1	72.7 Percent of participants Interval 60.4 to 83.0
Immune-related Disease Control Rate (irDCR) Per irRC and Disease Control Rate (DCR) Per mWHO Criteria in Participants With NSCLC and SCLC rDCR (irRC) SCLC cohort (n=43, 42, 45)	81.4 Percent of participants Interval 66.6 to 91.6	92.9 Percent of participants Interval 80.5 to 98.5	95.6 Percent of participants Interval 84.9 to 99.5
Immune-related Disease Control Rate (irDCR) Per irRC and Disease Control Rate (DCR) Per mWHO Criteria in Participants With NSCLC and SCLC DCR (mWHO criteria) SCLC cohort (n=43, 42, 45)	69.8 Percent of participants Interval 53.9 to 82.8	81.0 Percent of participants Interval 65.9 to 91.4	93.3 Percent of participants Interval 81.7 to 98.6

SECONDARY outcome

Timeframe: Date of irCR or irPR to date of irPD or death (maximum reached: 14.2 months)

Population: All participants who were randomized to a treatment group.

irDoR is defined as the time between the date of response of confirmed irCR or irPR and the date of irPD or death, whichever occurs first. For those participants who remain alive and did progress following response, irDoR was censored on the date of last evaluable tumor assessment. By mWHO criteria, DoR is defined as the time between the date of response of confirmed CR or PR and the date of PD or death, whichever occurs first. For those who remain alive and did not progress following response, DoR was censored on the date of last evaluable tumor assessment.

Outcome measures

Outcome measures
Measure	Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) n=113 Participants During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered intravenously (IV) as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until immune-related progressive disease (irPD), drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.	Ipilimumab + Paclitaxel/Carboplatin (Sequential) n=110 Participants During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.	Placebo + Paclitaxel/Carboplatin n=111 Participants During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
Immune-related Duration of Response (irDoR) Per irRC and DoR Per mWHO Criteria in Participants With NSCLC and SCLC DoR (mWHO criteria) SCLC cohort (n=43, 42, 45)	7.62 Months Interval 4.9 to 11.1	5.78 Months Interval 3.94 to 6.57	4.21 Months Interval 3.91 to 5.95
Immune-related Duration of Response (irDoR) Per irRC and DoR Per mWHO Criteria in Participants With NSCLC and SCLC irDoR (irRC) NSCLC cohort (n=70, 63, 62)	6.70 Months Interval 4.21 to 8.51	5.55 Months Interval 4.27 to 6.74	4.01 Months Interval 4.01 to 5.72
Immune-related Duration of Response (irDoR) Per irRC and DoR Per mWHO Criteria in Participants With NSCLC and SCLC DoR (mWHO criteria) NSCLC cohort (n=70, 63, 62)	5.42 Months Interval 4.21 to 7.43	5.55 Months Interval 4.27 to 6.74	4.01 Months Interval 3.94 to 5.59
Immune-related Duration of Response (irDoR) Per irRC and DoR Per mWHO Criteria in Participants With NSCLC and SCLC irDoR (irRC) SCLC cohort (n=43, 42, 45)	5.95 Months Interval 4.53 to 10.8	5.78 Months Interval 4.44 to 6.67	4.21 Months Interval 3.91 to 6.41

SECONDARY outcome

Timeframe: Weeks 4, 7, 10, 16, 19, and 24; at end of treatment; and at follow-up (70 days from last dose)

Population: All participants with NSCLC who received at least 1 dose of blinded active or placebo ipilimumab with or without paclitaxel/carboplatin. One NSCLC participant randomized to the sequential arm is included in the concurrent arm for safety evaulations.

AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=possibly, probably, or certainly related to and of unknown relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.

Outcome measures

Outcome measures
Measure	Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) n=71 Participants During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered intravenously (IV) as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until immune-related progressive disease (irPD), drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.	Ipilimumab + Paclitaxel/Carboplatin (Sequential) n=67 Participants During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.	Placebo + Paclitaxel/Carboplatin n=65 Participants During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade Deaths (total)	52 Participants	50 Participants	51 Participants
Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade Deaths within 30 days of last dose of study drug	11 Participants	7 Participants	8 Participants
Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade Deaths within 70 days of last dose of study drug	21 Participants	16 Participants	18 Participants
Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade SAEs (total)	49 Participants	36 Participants	33 Participants
Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade SAEs, Grade 3	17 Participants	16 Participants	9 Participants
Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade SAEs, Grade 4	10 Participants	4 Participants	5 Participants
Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade SAEs, Grade 5	20 Participants	15 Participants	18 Participants
Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade SAEs, Drug-related	20 Participants	13 Participants	11 Participants
Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade SAEs, Drug-related Grade 5	2 Participants	1 Participants	2 Participants
Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade AEs leading to discontinuation (disc) (total)	28 Participants	19 Participants	15 Participants
Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade AEs leading to disc, Drug-related (all)	16 Participants	7 Participants	8 Participants
Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade AEs leading to disc, Drug-related Grade 3	9 Participants	6 Participants	4 Participants
Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade AEs leading to disc, Drug-related Grade 4	1 Participants	0 Participants	0 Participants
Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade AEs leading to disc, Drug-related Grade 5	1 Participants	0 Participants	1 Participants
Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade AEs (total)	71 Participants	64 Participants	64 Participants
Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade AEs, Grades 3 and 4	40 Participants	36 Participants	26 Participants
Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade AEs, Drug-related Any Grade	56 Participants	56 Participants	54 Participants
Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade AEs, Drug-related Grades 3 and 4	29 Participants	26 Participants	24 Participants
Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade AEs, Drug-related Grade 5	2 Participants	1 Participants	2 Participants

SECONDARY outcome

Timeframe: At screening; predose Day 1; and Weeks 4, 7, 10, 13, 16, 19, and 24; and every 12 weeks on maintenance until disease progression, study closure, or withdrawal of consent

Population: All participants with NSCLC who received at least 1 dose of ipilimumab/placebo and/or chemotherapy and had at least 1 on-study hematology test result available. One NSCLC participant randomized to the sequential arm is included in the concurrent arm for safety evaulations.

CTC, Version 3 used to assess parameters. LLN=lower limit of normal. CTC criteria: ANC=absolute neutrophil count. White blood cells Grade (Gr) 1:\<LLN to 3.0\*10\^9/L, Gr 2:\<3.0 to 2.0\*10\^9/L, Gr 3:\<2.0 to 1.0\*10\^9/L, Gr 4:\<1.0\*10\^9/L. ANC Gr 1:\<LLN to 1.5\*10\^9/L, Gr 2:\<1.5 to 1.0\*10\^9/L, Gr 3:\<1.0 to 0.5\*10\^9/L, Gr 4:\<0.5\*10\^9/L. Platelet count Gr 1:LLN to 75.0\*10\^9/L, Gr 2:\<75.0 to 50.0\*10\^9/L, Gr 3:\<50.0 to 25.0\*10\^9/L, Gr 4:\<25.0 to 10\^9/L. Hemoglobin Gr 1:\<LLN to 10.0 g/dL, Gr 2:\<10.0 to 8.0 g/dL, Gr 3:\<8.0 to 6.5 g/dL, Gr 4:\<6.5 g/dL.

Outcome measures

Outcome measures
Measure	Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) n=71 Participants During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered intravenously (IV) as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until immune-related progressive disease (irPD), drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.	Ipilimumab + Paclitaxel/Carboplatin (Sequential) n=67 Participants During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.	Placebo + Paclitaxel/Carboplatin n=65 Participants During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
Percentage of Participants With NSCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade White blood cell count, Grades 3 and 4	7.7 Percentage of participants	6.2 Percentage of participants	3.2 Percentage of participants
Percentage of Participants With NSCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade Hemoglobin, Any grade	90.8 Percentage of participants	98.5 Percentage of participants	90.2 Percentage of participants
Percentage of Participants With NSCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade Hemoglobin, Grades 3 and 4	10.8 Percentage of participants	6.2 Percentage of participants	6.3 Percentage of participants
Percentage of Participants With NSCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade ANC, Grades 3 and 4	7.7 Percentage of participants	1.5 Percentage of participants	9.5 Percentage of participants
Percentage of Participants With NSCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade Platelets, Grades 3 and 4	1.5 Percentage of participants	3.1 Percentage of participants	9.5 Percentage of participants

SECONDARY outcome

Timeframe: Randomization date to date of irPD or death (maximum reached: 22 months)

Population: All participants with SCLC who were randomized to a treatment group.

IRC performed TA.

Outcome measures

Outcome measures
Measure	Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) n=43 Participants During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered intravenously (IV) as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until immune-related progressive disease (irPD), drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.	Ipilimumab + Paclitaxel/Carboplatin (Sequential) n=42 Participants During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.	Placebo + Paclitaxel/Carboplatin n=45 Participants During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
irPFS in Participants With SCLC Per irRC	5.68 Months Interval 5.19 to 6.87	6.44 Months Interval 5.29 to 7.75	5.26 Months Interval 4.67 to 5.72

SECONDARY outcome

Timeframe: At screening; predose Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and every 12 weeks on maintenance until disease progression, study closure, or withdrawal of consent

Population: All participants with NSCLC who received at least 1 dose of ipilimumab and/or chemotherapy and had at least 1 on-study liver function measurement available. One NSCLC participant randomized to the sequential arm is included in the concurrent arm for safety evaulations.

ULN=Upper limit of normal among all laboratory ranges. ALT=alanine transaminase; AST=aspartate aminotransferase; ALK=alkaline phosphatase. CTC grade criteria: ALT Grade 1:\>ULN to 2.5\*ULN; Grade 2: \>2.5 to 5.0\*ULN; Grade 3: \>5.0 to 20.0\*ULN; Grade 4: \>20.0\*ULN. AST Grade 1: \>ULN to 2.5\*ULN; Grade 2: \>2.5 to 5.0\*ULN; Grade 3: \>5.0 to 20.0\*ULN; Grade 4: \>20.0\*ULN. Total bilirubin Grade 1: \>ULN to 1.5\*ULN; Grade 2: \>1.5 to 3.0\*ULN; Grade 3: \>3.0 to 10.0\*ULN; Grade 4: \>10.0\*ULN. ALK (U/L) G1:\>ULN to 2.5\*ULN, G2:\>2.5 to 5.0\*ULN, G3:\>5.0 to 20.0\*ULN, G4:\>20.0\*ULN.

Outcome measures

Outcome measures
Measure	Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) n=65 Participants During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered intravenously (IV) as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until immune-related progressive disease (irPD), drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.	Ipilimumab + Paclitaxel/Carboplatin (Sequential) n=65 Participants During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.	Placebo + Paclitaxel/Carboplatin n=62 Participants During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
Number of Participants With NSCLC Who Have Abnormalities in On-Study Liver Function Test Results By Worst CTC Grade Alanine aminotransferase (ALT), Grade 1	24 Participants	15 Participants	19 Participants
Number of Participants With NSCLC Who Have Abnormalities in On-Study Liver Function Test Results By Worst CTC Grade ALT, Grade 2	2 Participants	4 Participants	3 Participants
Number of Participants With NSCLC Who Have Abnormalities in On-Study Liver Function Test Results By Worst CTC Grade ALT, Grades 3 and 4	1 Participants	1 Participants	1 Participants
Number of Participants With NSCLC Who Have Abnormalities in On-Study Liver Function Test Results By Worst CTC Grade Aspartate aminotransferase (AST), Grade 1	16 Participants	18 Participants	20 Participants
Number of Participants With NSCLC Who Have Abnormalities in On-Study Liver Function Test Results By Worst CTC Grade AST, Grade 2	0 Participants	2 Participants	0 Participants
Number of Participants With NSCLC Who Have Abnormalities in On-Study Liver Function Test Results By Worst CTC Grade AST, Grades 3 and 4	1 Participants	1 Participants	1 Participants
Number of Participants With NSCLC Who Have Abnormalities in On-Study Liver Function Test Results By Worst CTC Grade Total bilirubin, Grade 1	1 Participants	3 Participants	2 Participants
Number of Participants With NSCLC Who Have Abnormalities in On-Study Liver Function Test Results By Worst CTC Grade Total bilirubin, Grade 2	3 Participants	2 Participants	1 Participants
Number of Participants With NSCLC Who Have Abnormalities in On-Study Liver Function Test Results By Worst CTC Grade Total bilirubin, Grades 3 and 4	0 Participants	0 Participants	0 Participants
Number of Participants With NSCLC Who Have Abnormalities in On-Study Liver Function Test Results By Worst CTC Grade Alkaline phosphatase, Grade 1	24 Participants	28 Participants	24 Participants
Number of Participants With NSCLC Who Have Abnormalities in On-Study Liver Function Test Results By Worst CTC Grade Alkaline phosphatase, Grade 2	1 Participants	2 Participants	3 Participants
Number of Participants With NSCLC Who Have Abnormalities in On-Study Liver Function Test Results By Worst CTC Grade Alkaline phosphatase, Grades 3 and 4	0 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: At screening; Day 1; Weeks 4, 7, 10, 13, 16, and 24; and every 12 weeks on maintenance until disease progression, study closure, or withdrawal of consent

Population: All participants with NSCLC who received at least 1 dose of ipilimumab/placebo and/or chemotherapy and had at least 1 on-study measurement available.One NSCLC participant randomized to the sequential arm is included in the concurrent arm for safety evaulations.

Vital signs measurements consisted of systolic and diastolic blood pressure, heart rate, temperature, and respiratory rate. Physical examinations assessed weight, height, performance status, and body surface area.

Outcome measures

Outcome measures
Measure	Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) n=71 Participants During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered intravenously (IV) as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until immune-related progressive disease (irPD), drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.	Ipilimumab + Paclitaxel/Carboplatin (Sequential) n=67 Participants During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.	Placebo + Paclitaxel/Carboplatin n=65 Participants During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
Number of Participants With NSCLC Who Had Abnormalities in Vital Sign Measurements and Physical Examination Findings Vital sign measurements	0 Participants	0 Participants	0 Participants
Number of Participants With NSCLC Who Had Abnormalities in Vital Sign Measurements and Physical Examination Findings Physical examination findings	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: At screening; predose Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and at end of treatment

Population: All participants with NSCLC who received at least 1 dose of ipilimumab/placebo and/or chemotherapy and had at least 1 on-study pancreatic enzyme laboratory test measurement available. One NSCLC participant randomized to the sequential arm is included in the concurrent arm for safety evaulations.

ULN=upper limit of normal. Lipase (U/L) Gr 1: 1.1 to 1.39\*ULN; Gr 2: \>1.5 to 2.0\*ULN; Gr 3: 2.5 to 5; Gr 4: 5\*ULN. Amylase (U/L) Gr 1: \>ULN to 1.5\*ULN; Grade 2 \>1.5 to 2.0\*ULN, Grade 3 \>2.0 to 5.0\*ULN, Grade 4 \>5.0\*ULN. Creatine (mg/dL) Grade 1: \>ULN to 1.5\*ULN, Gr 2: 1.5 to 3.0\*ULN, Gr 3: \>3.0 to 6.0\*ULN, Gr 4: \>6.0\*ULN.

Outcome measures

Outcome measures
Measure	Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) n=71 Participants During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered intravenously (IV) as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until immune-related progressive disease (irPD), drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.	Ipilimumab + Paclitaxel/Carboplatin (Sequential) n=67 Participants During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.	Placebo + Paclitaxel/Carboplatin n=65 Participants During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
Percentage of Participants With NSCLC Who Have Abnormalities in Pancreatic Enzyme Clinical Laboratory Test Results by Worst CTC Grade Lipase, Grades 3 and 4	7.7 Percentage of participants	6.2 Percentage of participants	3.2 Percentage of participants
Percentage of Participants With NSCLC Who Have Abnormalities in Pancreatic Enzyme Clinical Laboratory Test Results by Worst CTC Grade Amylase, Grades 3 and 4	1.5 Percentage of participants	4.6 Percentage of participants	1.6 Percentage of participants

SECONDARY outcome

Timeframe: Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and at end of treatment

Population: Participants with at least 1 HAHA measurement prior to and at least 1 after the first ipilimumab dose and with an increase in HAHA measurement from baseline.

An electrochemilumiluminescent immunoassay was used to detect HAHA antibodies to ipilimumab in human serum. Baseline, either negative or positive, is the maximum of all measurements closest and prior to the first ipilimumab dose. Positive status postbaseline=participants with an increase in HAHA measurement from baseline.

Outcome measures

Outcome measures
Measure	Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) n=61 Participants During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered intravenously (IV) as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until immune-related progressive disease (irPD), drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.	Ipilimumab + Paclitaxel/Carboplatin (Sequential) n=56 Participants During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.	Placebo + Paclitaxel/Carboplatin During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
Number of Participants With NSCLC Who Have Positive Human Antihuman Antibody (HAHA) Status Postbaseline	2 Participants	1 Participants	—

SECONDARY outcome

Timeframe: Weeks 4, 7, 10, 16, 19, and 24; at end of treatment; and at follow-up (70 days from last dose)

Population: All participants with SCLC who received at least 1 dose of blinded active or placebo ipilimumab with or without paclitaxel/carboplatin.

Outcome measures

Outcome measures
Measure	Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) n=42 Participants During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered intravenously (IV) as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until immune-related progressive disease (irPD), drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.	Ipilimumab + Paclitaxel/Carboplatin (Sequential) n=42 Participants During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.	Placebo + Paclitaxel/Carboplatin n=44 Participants During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade AEs, Drug-related (all)	36 Participants	40 Participants	40 Participants
Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade AEs, Drug-related,Grades 3 and 4	18 Participants	21 Participants	13 Participants
Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade Deaths (total)	37 Participants	31 Participants	35 Participants
Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade Deaths within 30 days of last dose of study drug	6 Participants	2 Participants	1 Participants
Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade Deaths within 70 days of last dose of study drug	13 Participants	7 Participants	8 Participants
Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade SAEs (total)	25 Participants	21 Participants	20 Participants
Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade SAEs, Grade 3	7 Participants	6 Participants	4 Participants
Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade SAEs, Grade 4	3 Participants	4 Participants	4 Participants
Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade SAEs, Grade 5	12 Participants	7 Participants	7 Participants
Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade SAEs, Drug-related	10 Participants	12 Participants	6 Participants
Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade SAEs, Drug-related Grade 5	1 Participants	0 Participants	0 Participants
Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade AEs leading to discontinuation (disc) (total)	14 Participants	13 Participants	12 Participants
Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade AEs leading to disc, Drug-related (all)	9 Participants	7 Participants	7 Participants
Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade AEs leading to disc, Drug-related Grade 3	3 Participants	3 Participants	4 Participants
Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade AEs leading to disc, Drug-related Grade 4	2 Participants	2 Participants	0 Participants
Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade AEs leading to disc, Drug-related Grade 5	1 Participants	0 Participants	0 Participants
Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade AEs (total)	41 Participants	40 Participants	43 Participants
Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade AEs, Grades 3 and 4	19 Participants	22 Participants	19 Participants
Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade AEs, Grade 5	12 Participants	7 Participants	7 Participants
Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade AEs, Drug-related, Grade 5	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: At screening, predose Day 1, and Weeks 4, 7, 10, 13, 16, 19, 24, and at end of treatment

Population: All participants with SCLC who received at least 1 dose of ipilimumab and/or chemotherapy and had at least 1 on-study hematology test result available.

CTC, Version 3 used to assess parameters. LLN=lower limit of normal. CTC criteria: ANC=absolute neutrophil count. White blood cells Gr 1:\<LLN to 3.0\*10\^9/L, Gr 2:\<3.0 to 2.0\*10\^9/L, Gr 3:\<2.0 to 1.0\*10\^9/L, Gr 4:\<1.0\*10\^9/L. ANC Gr 1:\<LLN to 1.5\*10\^9/L, Gr 2:\<1.5 to 1.0\*10\^9/L, Gr 3:\<1.0 to 0.5\*10\^9/L, Gr 4:\<0.5\*10\^9/L. Platelet count Gr 1:LLN to 75.0\*10\^9/L, Gr 2:\<75.0 to 50.0\*10\^9/L, Gr 3:\<50.0 to 25.0\*10\^9/L, Gr 4:\<25.0 to 10\^9/L. Hemoglobin Gr 1:\<LLN to 10.0 g/dL, Gr 2:\<10.0 to 8.0 g/dL, Gr 3:\<8.0 to 6.5 g/dL, Gr 4:\<6.5 g/dL.

Outcome measures

Outcome measures
Measure	Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) n=42 Participants During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered intravenously (IV) as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until immune-related progressive disease (irPD), drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.	Ipilimumab + Paclitaxel/Carboplatin (Sequential) n=42 Participants During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.	Placebo + Paclitaxel/Carboplatin n=44 Participants During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade White blood cells, Grade 1 (n=39, 42, 43)	7 Participants	11 Participants	13 Participants
Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade White blood cells, Grade 2 (n= 39, 42, 43)	10 Participants	9 Participants	7 Participants
Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade White blood cells, Grades 3 (n= 39, 42, 43)	0 Participants	2 Participants	0 Participants
Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade White blood cells, Grade 4 (n= 39, 42, 43)	0 Participants	0 Participants	0 Participants
Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade Absolute neutrophil count, Grade 1 (n= 39, 42, 43)	8 Participants	8 Participants	8 Participants
Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade Absolute neutrophil count, Grade 2 (n= 39, 42, 43)	8 Participants	9 Participants	91 Participants
Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade Absolute neutrophil count, Grade 3 (n= 39, 42, 43)	2 Participants	2 Participants	1 Participants
Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade Absolute neutrophil count, Grade 4 (n= 39, 42, 43)	1 Participants	2 Participants	0 Participants
Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade Platelet count, Grade 1 (n= 39, 42, 43)	15 Participants	18 Participants	23 Participants
Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade Platelet count, Grade 2 (n= 39, 42, 43)	2 Participants	3 Participants	3 Participants
Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade Platelet count, Grade 3 (n= 39, 42, 43)	1 Participants	2 Participants	1 Participants
Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade Platelet count, Grade 4 (n= 39, 42, 43)	0 Participants	1 Participants	0 Participants
Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade Hemoglobin, Grade 1 (n= 39, 42, 43)	26 Participants	24 Participants	25 Participants
Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade Hemoglobin, Grade 2 (n= 39, 42, 43)	8 Participants	10 Participants	11 Participants
Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade Hemoglobin, Grade 3 (n= 39, 42, 43)	2 Participants	2 Participants	3 Participants
Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade Hemoglobin, Grade 4 (n= 39, 42, 43)	0 Participants	2 Participants	0 Participants

SECONDARY outcome

Timeframe: At screening; predose Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and at end of treatment

Population: All participants with SCLC who received at least 1 dose of ipilimumab/placebo and/or chemotherapy and had at least 1 on-study liver function test result available.

ALT=alanine aminotransferase; AST=aspartate aminotransferase; ALK=alkaline phosphatase. ULN=Upper limit of normal among all laboratory ranges. CTC grade criteria: ALT Grade 1:\>ULN to 2.5\*ULN; Grade 2: \>2.5 to 5.0\*ULN; Grade 3: \>5.0 to 20.0\*ULN; Grade 4: \>20.0\*ULN. AST Grade 1: \>ULN to 2.5\*ULN; Grade 2: \>2.5 to 5.0\*ULN; Grade 3: \>5.0 to 20.0\*ULN; Grade 4: \>20.0\*ULN. Total bilirubin Grade 1: \>ULN to 1.5\*ULN; Grade 2: \>1.5 to 3.0\*ULN; Grade 3: \>3.0 to 10.0\*ULN; Grade 4: \>10.0\*ULN. ALK (U/L) G1:\>ULN to 2.5\*ULN, G2:\>2.5 to 5.0\*ULN, G3:\>5.0 to 20.0\*ULN, G4:\>20.0\*ULN.

Outcome measures

Outcome measures
Measure	Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) n=42 Participants During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered intravenously (IV) as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until immune-related progressive disease (irPD), drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.	Ipilimumab + Paclitaxel/Carboplatin (Sequential) n=42 Participants During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.	Placebo + Paclitaxel/Carboplatin n=44 Participants During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
Number of Participants With SCLC Who Have Abnormalities in Liver Function Test Results by Worst CTC Grade ALT, Grade 1	12 Participants	12 Participants	8 Participants
Number of Participants With SCLC Who Have Abnormalities in Liver Function Test Results by Worst CTC Grade ALT, Grade 2	2 Participants	3 Participants	1 Participants
Number of Participants With SCLC Who Have Abnormalities in Liver Function Test Results by Worst CTC Grade ALT, Grades 3 & 4	7 Participants	2 Participants	0 Participants
Number of Participants With SCLC Who Have Abnormalities in Liver Function Test Results by Worst CTC Grade AST, Grade 1	11 Participants	13 Participants	12 Participants
Number of Participants With SCLC Who Have Abnormalities in Liver Function Test Results by Worst CTC Grade AST, Grade 2	4 Participants	1 Participants	2 Participants
Number of Participants With SCLC Who Have Abnormalities in Liver Function Test Results by Worst CTC Grade AST, Grades 3 & 4	5 Participants	3 Participants	0 Participants
Number of Participants With SCLC Who Have Abnormalities in Liver Function Test Results by Worst CTC Grade Total bilirubin, Grade 1	4 Participants	5 Participants	3 Participants
Number of Participants With SCLC Who Have Abnormalities in Liver Function Test Results by Worst CTC Grade Total bilirubin, Grade 2	1 Participants	0 Participants	0 Participants
Number of Participants With SCLC Who Have Abnormalities in Liver Function Test Results by Worst CTC Grade Total bilirubin, Grades 3 & 4	1 Participants	0 Participants	0 Participants
Number of Participants With SCLC Who Have Abnormalities in Liver Function Test Results by Worst CTC Grade ALK, Grade 1	15 Participants	14 Participants	16 Participants
Number of Participants With SCLC Who Have Abnormalities in Liver Function Test Results by Worst CTC Grade ALK, Grade 2	1 Participants	3 Participants	2 Participants
Number of Participants With SCLC Who Have Abnormalities in Liver Function Test Results by Worst CTC Grade ALK, Grades 3 & 4	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: At screening, predose Day 1, and Weeks 4, 7, 10, 13, 16, 19, 24, and at end of treatment

Population: All participants with SCLC who received at least 1 dose of ipilimumab and/or chemotherapy and had at least 1 on-study pancreatic enzyme or other laboratory test measurement available.

ULN=upper limit of normal. Lipase (U/L) Grade (Gr) 1: 1.1 to 1.39\*ULN; Gr 2: \>1.5 to 2.0\*ULN; Gr 3: 2.5 to 5; Gr 4: 5\*ULN. Amylase (U/L) Gr 1: \>ULN to 1.5\*ULN; Gr 2 \>1.5 to 2.0\*ULN, Gr 3 \>2.0 to 5.0\*ULN, Gr 4 \>5.0\*ULN. Creatine (mg/dL) Gr 1: \>ULN to 1.5\*ULN, Gr 2: 1.5 to 3.0\*ULN, Gr 3: \>3.0 to 6.0\*ULN, Gr 4: \>6.0\*ULN.

Outcome measures

Outcome measures
Measure	Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) n=42 Participants During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered intravenously (IV) as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until immune-related progressive disease (irPD), drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.	Ipilimumab + Paclitaxel/Carboplatin (Sequential) n=42 Participants During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.	Placebo + Paclitaxel/Carboplatin n=44 Participants During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
Percentage of Participants With SCLC Who Have Abnormalities in Pancreatic Enzyme and Other Clinical Laboratory Test Results by Worst CTC Grade Lipase, Grades 3 and 4	7.7 Percentage of participants	16.7 Percentage of participants	11.6 Percentage of participants
Percentage of Participants With SCLC Who Have Abnormalities in Pancreatic Enzyme and Other Clinical Laboratory Test Results by Worst CTC Grade Amylase, Grades 3 and 4	5.1 Percentage of participants	4.8 Percentage of participants	4.7 Percentage of participants
Percentage of Participants With SCLC Who Have Abnormalities in Pancreatic Enzyme and Other Clinical Laboratory Test Results by Worst CTC Grade Creatinine, Grades 3 and 4	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants

SECONDARY outcome

Timeframe: Randomization date to date of progression or death (of censored, maximum reached: 22 months)

Population: All participants with SCLC who were randomized to a treatment group.

Outcome measures

Outcome measures
Measure	Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) n=43 Participants During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered intravenously (IV) as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until immune-related progressive disease (irPD), drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.	Ipilimumab + Paclitaxel/Carboplatin (Sequential) n=42 Participants During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.	Placebo + Paclitaxel/Carboplatin n=45 Participants During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
Progression-free Survival (PFS) in Participants With SCLC Per mWHO Criteria	3.89 Months Interval 2.89 to 5.85	5.22 Months Interval 4.14 to 6.57	5.19 Months Interval 4.4 to 5.59

SECONDARY outcome

Timeframe: Predose Day 1; Weeks 4, 7, 10, 13, 16, and 24; and every 12 weeks on maintenance until end of treatment

Population: All participants with SCLC who received at least 1 dose of ipilimumab/placebo and/or chemotherapy and had at least 1 on-study measurement available.

Outcome measures

Outcome measures
Measure	Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) n=42 Participants During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered intravenously (IV) as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until immune-related progressive disease (irPD), drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.	Ipilimumab + Paclitaxel/Carboplatin (Sequential) n=42 Participants During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.	Placebo + Paclitaxel/Carboplatin n=44 Participants During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
Number of Participants With SCLC Who Had Abnormalities in Vital Sign Measurements and Physical Examination Findings Vital sign measurements	0 Participants	0 Participants	0 Participants
Number of Participants With SCLC Who Had Abnormalities in Vital Sign Measurements and Physical Examination Findings Physical examination findings	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and at end of treatment

Population: Participants with SCLC who had at least 1 HAHA measurement prior to and at least 1 after the first ipilimumab dose and with an increase in HAHA measurement from baseline.

Outcome measures

Outcome measures
Measure	Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) n=38 Participants During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered intravenously (IV) as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until immune-related progressive disease (irPD), drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.	Ipilimumab + Paclitaxel/Carboplatin (Sequential) n=41 Participants During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.	Placebo + Paclitaxel/Carboplatin During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
Number of Participants With SCLC Who Have Positive HAHA Status Postbaseline Positive at any timepoint (n=42, 42)	2 Participants	3 Participants	—
Number of Participants With SCLC Who Have Positive HAHA Status Postbaseline Positive postbaseline (n=38, 41)	2 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Randomization date to date of death (of censored, maximum reached: 22 months)

Population: All participants with SCLC who were randomized to a treatment group.

Outcome measures

Outcome measures
Measure	Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) n=43 Participants During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered intravenously (IV) as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until immune-related progressive disease (irPD), drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.	Ipilimumab + Paclitaxel/Carboplatin (Sequential) n=42 Participants During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.	Placebo + Paclitaxel/Carboplatin n=45 Participants During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
Overall Survival in Participants With SCLC	3.89 Months Interval 2.89 to 5.85	5.22 Months Interval 4.14 to 6.57	5.19 Months Interval 4.4 to 5.59

Adverse Events

Ipilimubab+Paclitaxel/Carboplatin (Concurrent) NSCLC

Serious events: 49 serious events

Other events: 63 other events

Deaths: 0 deaths

Placebo/Ipilimumab+ Paclitaxel/Carboplatin (Sequential) NSCLC

Serious events: 36 serious events

Other events: 63 other events

Deaths: 0 deaths

Placebo + Paclitaxel/Carboplatin NSCLC

Serious events: 33 serious events

Other events: 59 other events

Deaths: 0 deaths

Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) SCLC

Serious events: 25 serious events

Other events: 36 other events

Deaths: 0 deaths

Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential) SCLC

Serious events: 21 serious events

Other events: 39 other events

Deaths: 0 deaths

Placebo + Paclitaxel/Carboplatin SCLC

Serious events: 20 serious events

Other events: 41 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Ipilimubab+Paclitaxel/Carboplatin (Concurrent) NSCLC n=71 participants at risk During induction, participants with nonsmall-cell lung cancer (NSCLC) received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered intravenously (IV) as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered intravenously (IV) over 90 minutes every 12 weeks starting 24 weeks after the first dose until immune-related progressive disease (irPD), drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.	Placebo/Ipilimumab+ Paclitaxel/Carboplatin (Sequential) NSCLC n=67 participants at risk During induction, participants with NSCLC received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.	Placebo + Paclitaxel/Carboplatin NSCLC n=65 participants at risk During induction, participants with NSCLC received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.	Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) SCLC n=42 participants at risk During induction, participants with small-cell lung cancer (SCLC) received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.	Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential) SCLC n=42 participants at risk During induction, participants with SCLC received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until progressive disease, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.	Placebo + Paclitaxel/Carboplatin SCLC n=44 participants at risk During induction, participants with SCLC received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
Infections and infestations SIALOADENITIS	0.00% 0/71	0.00% 0/67	1.5% 1/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Nervous system disorders SYNCOPE	1.4% 1/71	1.5% 1/67	1.5% 1/65	0.00% 0/42	0.00% 0/42	2.3% 1/44
Neoplasms benign, malignant and unspecified (incl cysts and polyps) TUMOUR PAIN	0.00% 0/71	0.00% 0/67	1.5% 1/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Infections and infestations URINARY TRACT INFECTION	1.4% 1/71	0.00% 0/67	1.5% 1/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Cardiac disorders ACUTE MYOCARDIAL INFARCTION	1.4% 1/71	0.00% 0/67	0.00% 0/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Blood and lymphatic system disorders ANAEMIA	5.6% 4/71	6.0% 4/67	1.5% 1/65	0.00% 0/42	4.8% 2/42	4.5% 2/44
Vascular disorders ARTERIAL THROMBOSIS	0.00% 0/71	0.00% 0/67	0.00% 0/65	0.00% 0/42	2.4% 1/42	0.00% 0/44
Hepatobiliary disorders AUTOIMMUNE HEPATITIS	0.00% 0/71	0.00% 0/67	0.00% 0/65	0.00% 0/42	2.4% 1/42	0.00% 0/44
Psychiatric disorders CONFUSIONAL STATE	0.00% 0/71	0.00% 0/67	1.5% 1/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Infections and infestations GASTROENTERITIS SHIGELLA	0.00% 0/71	0.00% 0/67	1.5% 1/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Endocrine disorders HYPOPITUITARISM	1.4% 1/71	0.00% 0/67	0.00% 0/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MALIGNANT PLEURAL EFFUSION	1.4% 1/71	0.00% 0/67	0.00% 0/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Metabolism and nutrition disorders METABOLIC ACIDOSIS	1.4% 1/71	0.00% 0/67	0.00% 0/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Neoplasms benign, malignant and unspecified (incl cysts and polyps) METASTATIC NEOPLASM	0.00% 0/71	0.00% 0/67	0.00% 0/65	0.00% 0/42	2.4% 1/42	0.00% 0/44
Musculoskeletal and connective tissue disorders MUSCULAR WEAKNESS	0.00% 0/71	1.5% 1/67	4.6% 3/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Gastrointestinal disorders NAUSEA	0.00% 0/71	1.5% 1/67	3.1% 2/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	0.00% 0/71	1.5% 1/67	1.5% 1/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Cardiac disorders PERICARDIAL EFFUSION	1.4% 1/71	0.00% 0/67	0.00% 0/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Infections and infestations SEPSIS	1.4% 1/71	0.00% 0/67	0.00% 0/65	2.4% 1/42	2.4% 1/42	2.3% 1/44
Respiratory, thoracic and mediastinal disorders ACUTE RESPIRATORY FAILURE	0.00% 0/71	1.5% 1/67	0.00% 0/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Investigations ALANINE AMINOTRANSFERASE INCREASED	1.4% 1/71	0.00% 0/67	0.00% 0/65	4.8% 2/42	2.4% 1/42	0.00% 0/44
Cardiac disorders ATRIAL FIBRILLATION	1.4% 1/71	0.00% 0/67	0.00% 0/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Cardiac disorders CARDIAC FAILURE	0.00% 0/71	0.00% 0/67	0.00% 0/65	2.4% 1/42	0.00% 0/42	0.00% 0/44
Metabolism and nutrition disorders DEHYDRATION	2.8% 2/71	3.0% 2/67	6.2% 4/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Infections and infestations ERYSIPELAS	0.00% 0/71	1.5% 1/67	0.00% 0/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Skin and subcutaneous tissue disorders ERYTHEMA MULTIFORME	1.4% 1/71	0.00% 0/67	0.00% 0/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Blood and lymphatic system disorders FEBRILE NEUTROPENIA	2.8% 2/71	1.5% 1/67	3.1% 2/65	2.4% 1/42	0.00% 0/42	0.00% 0/44
Hepatobiliary disorders HEPATITIS	0.00% 0/71	0.00% 0/67	0.00% 0/65	2.4% 1/42	0.00% 0/42	0.00% 0/44
Vascular disorders HYPOTENSION	1.4% 1/71	1.5% 1/67	3.1% 2/65	2.4% 1/42	0.00% 0/42	2.3% 1/44
Blood and lymphatic system disorders LEUKOCYTOSIS	0.00% 0/71	1.5% 1/67	0.00% 0/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG NEOPLASM	0.00% 0/71	1.5% 1/67	0.00% 0/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MALIGNANT NEOPLASM PROGRESSION	2.8% 2/71	0.00% 0/67	0.00% 0/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Respiratory, thoracic and mediastinal disorders PLEURAL EFFUSION	4.2% 3/71	0.00% 0/67	1.5% 1/65	0.00% 0/42	2.4% 1/42	0.00% 0/44
Respiratory, thoracic and mediastinal disorders PNEUMOTHORAX	0.00% 0/71	0.00% 0/67	1.5% 1/65	2.4% 1/42	0.00% 0/42	0.00% 0/44
Respiratory, thoracic and mediastinal disorders PULMONARY EMBOLISM	5.6% 4/71	3.0% 2/67	1.5% 1/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Investigations WEIGHT DECREASED	1.4% 1/71	0.00% 0/67	0.00% 0/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Respiratory, thoracic and mediastinal disorders BRONCHITIS CHRONIC	0.00% 0/71	0.00% 0/67	0.00% 0/65	0.00% 0/42	0.00% 0/42	2.3% 1/44
Metabolism and nutrition disorders CACHEXIA	0.00% 0/71	0.00% 0/67	0.00% 0/65	0.00% 0/42	2.4% 1/42	0.00% 0/44
Nervous system disorders CEREBRAL HAEMORRHAGE	1.4% 1/71	0.00% 0/67	0.00% 0/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Gastrointestinal disorders COLITIS	0.00% 0/71	3.0% 2/67	0.00% 0/65	0.00% 0/42	2.4% 1/42	0.00% 0/44
Gastrointestinal disorders CONSTIPATION	0.00% 0/71	0.00% 0/67	1.5% 1/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Nervous system disorders DYSARTHRIA	0.00% 0/71	0.00% 0/67	0.00% 0/65	0.00% 0/42	2.4% 1/42	0.00% 0/44
Gastrointestinal disorders DYSPHAGIA	0.00% 0/71	3.0% 2/67	0.00% 0/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Infections and infestations GASTROENTERITIS	1.4% 1/71	0.00% 0/67	0.00% 0/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
General disorders GENERAL PHYSICAL HEALTH DETERIORATION	2.8% 2/71	1.5% 1/67	0.00% 0/65	4.8% 2/42	0.00% 0/42	0.00% 0/44
Nervous system disorders HEADACHE	0.00% 0/71	3.0% 2/67	0.00% 0/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Hepatobiliary disorders HEPATITIS ACUTE	1.4% 1/71	0.00% 0/67	0.00% 0/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Nervous system disorders HYDROCEPHALUS	0.00% 0/71	0.00% 0/67	0.00% 0/65	0.00% 0/42	2.4% 1/42	0.00% 0/44
Metabolism and nutrition disorders HYPERGLYCAEMIA	1.4% 1/71	1.5% 1/67	0.00% 0/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Endocrine disorders HYPOPHYSITIS	1.4% 1/71	0.00% 0/67	0.00% 0/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
General disorders MULTI-ORGAN FAILURE	0.00% 0/71	0.00% 0/67	0.00% 0/65	0.00% 0/42	2.4% 1/42	0.00% 0/44
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PERICARDIAL EFFUSION MALIGNANT	0.00% 0/71	0.00% 0/67	1.5% 1/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Vascular disorders PERIPHERAL ISCHAEMIA	1.4% 1/71	0.00% 0/67	0.00% 0/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
General disorders PYREXIA	1.4% 1/71	4.5% 3/67	0.00% 0/65	9.5% 4/42	0.00% 0/42	0.00% 0/44
Skin and subcutaneous tissue disorders RASH	1.4% 1/71	1.5% 1/67	1.5% 1/65	2.4% 1/42	0.00% 0/42	0.00% 0/44
Skin and subcutaneous tissue disorders RASH MACULAR	1.4% 1/71	0.00% 0/67	0.00% 0/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Cardiac disorders TACHYARRHYTHMIA	0.00% 0/71	0.00% 0/67	0.00% 0/65	0.00% 0/42	0.00% 0/42	2.3% 1/44
Vascular disorders THROMBOPHLEBITIS	0.00% 0/71	1.5% 1/67	0.00% 0/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Gastrointestinal disorders VOMITING	0.00% 0/71	3.0% 2/67	3.1% 2/65	0.00% 0/42	0.00% 0/42	4.5% 2/44
General disorders ASTHENIA	1.4% 1/71	1.5% 1/67	1.5% 1/65	2.4% 1/42	0.00% 0/42	0.00% 0/44
Nervous system disorders ATAXIA	0.00% 0/71	0.00% 0/67	0.00% 0/65	0.00% 0/42	2.4% 1/42	0.00% 0/44
Respiratory, thoracic and mediastinal disorders BRONCHOSPASM	0.00% 0/71	0.00% 0/67	1.5% 1/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Infections and infestations CELLULITIS	0.00% 0/71	1.5% 1/67	0.00% 0/65	0.00% 0/42	0.00% 0/42	2.3% 1/44
Nervous system disorders EPILEPSY	0.00% 0/71	0.00% 0/67	1.5% 1/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Infections and infestations FEBRILE INFECTION	0.00% 0/71	0.00% 0/67	0.00% 0/65	2.4% 1/42	0.00% 0/42	0.00% 0/44
Infections and infestations GASTROINTESTINAL INFECTION	0.00% 0/71	0.00% 0/67	0.00% 0/65	2.4% 1/42	0.00% 0/42	0.00% 0/44
Gastrointestinal disorders GASTROOESOPHAGEAL REFLUX DISEASE	0.00% 0/71	0.00% 0/67	1.5% 1/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Metabolism and nutrition disorders HYPERCALCAEMIA	1.4% 1/71	0.00% 0/67	0.00% 0/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Gastrointestinal disorders ILEAL PERFORATION	1.4% 1/71	0.00% 0/67	0.00% 0/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG CANCER METASTATIC	0.00% 0/71	0.00% 0/67	1.5% 1/65	0.00% 0/42	2.4% 1/42	0.00% 0/44
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NEOPLASM PROGRESSION	4.2% 3/71	1.5% 1/67	4.6% 3/65	9.5% 4/42	4.8% 2/42	6.8% 3/44
Blood and lymphatic system disorders NEUTROPENIA	4.2% 3/71	0.00% 0/67	4.6% 3/65	0.00% 0/42	7.1% 3/42	6.8% 3/44
Respiratory, thoracic and mediastinal disorders OBSTRUCTIVE AIRWAYS DISORDER	0.00% 0/71	0.00% 0/67	1.5% 1/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
General disorders OEDEMA PERIPHERAL	0.00% 0/71	1.5% 1/67	0.00% 0/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Eye disorders OPTIC ISCHAEMIC NEUROPATHY	0.00% 0/71	0.00% 0/67	0.00% 0/65	0.00% 0/42	2.4% 1/42	0.00% 0/44
Infections and infestations PSEUDOMONAL SEPSIS	0.00% 0/71	0.00% 0/67	1.5% 1/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Renal and urinary disorders RENAL FAILURE ACUTE	0.00% 0/71	0.00% 0/67	0.00% 0/65	0.00% 0/42	2.4% 1/42	0.00% 0/44
Skin and subcutaneous tissue disorders TOXIC EPIDERMAL NECROLYSIS	1.4% 1/71	0.00% 0/67	0.00% 0/65	0.00% 0/42	0.00% 0/42	2.3% 1/44
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	1.4% 1/71	0.00% 0/67	0.00% 0/65	4.8% 2/42	2.4% 1/42	0.00% 0/44
Infections and infestations BRONCHITIS	1.4% 1/71	0.00% 0/67	0.00% 0/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Nervous system disorders CERVICAL CORD COMPRESSION	0.00% 0/71	0.00% 0/67	1.5% 1/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
General disorders CHEST PAIN	0.00% 0/71	0.00% 0/67	0.00% 0/65	0.00% 0/42	0.00% 0/42	2.3% 1/44
Respiratory, thoracic and mediastinal disorders CHRONIC OBSTRUCTIVE PULMONARY DISEASE	0.00% 0/71	0.00% 0/67	0.00% 0/65	0.00% 0/42	2.4% 1/42	0.00% 0/44
Infections and infestations CLOSTRIDIUM DIFFICILE COLITIS	1.4% 1/71	0.00% 0/67	0.00% 0/65	0.00% 0/42	0.00% 0/42	2.3% 1/44
Skin and subcutaneous tissue disorders DERMATITIS EXFOLIATIVE	0.00% 0/71	0.00% 0/67	0.00% 0/65	2.4% 1/42	0.00% 0/42	0.00% 0/44
Respiratory, thoracic and mediastinal disorders HAEMOPTYSIS	0.00% 0/71	1.5% 1/67	0.00% 0/65	2.4% 1/42	0.00% 0/42	0.00% 0/44
Immune system disorders HYPERSENSITIVITY	1.4% 1/71	1.5% 1/67	1.5% 1/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Eye disorders MACULAR CYST	0.00% 0/71	1.5% 1/67	0.00% 0/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Metabolism and nutrition disorders MALNUTRITION	0.00% 0/71	1.5% 1/67	1.5% 1/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NON-SMALL CELL LUNG CANCER	0.00% 0/71	3.0% 2/67	1.5% 1/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
General disorders PAIN	0.00% 0/71	0.00% 0/67	0.00% 0/65	0.00% 0/42	0.00% 0/42	2.3% 1/44
Blood and lymphatic system disorders PANCYTOPENIA	1.4% 1/71	0.00% 0/67	0.00% 0/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Respiratory, thoracic and mediastinal disorders PNEUMONIA ASPIRATION	0.00% 0/71	0.00% 0/67	1.5% 1/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Gastrointestinal disorders SALIVARY GLAND CALCULUS	0.00% 0/71	0.00% 0/67	0.00% 0/65	0.00% 0/42	0.00% 0/42	2.3% 1/44
Infections and infestations SEPTIC SHOCK	0.00% 0/71	0.00% 0/67	1.5% 1/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Blood and lymphatic system disorders THROMBOCYTOPENIA	1.4% 1/71	0.00% 0/67	3.1% 2/65	0.00% 0/42	7.1% 3/42	2.3% 1/44
Injury, poisoning and procedural complications UPPER LIMB FRACTURE	1.4% 1/71	0.00% 0/67	0.00% 0/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Ear and labyrinth disorders VERTIGO	0.00% 0/71	1.5% 1/67	0.00% 0/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Gastrointestinal disorders ABDOMINAL DISTENSION	0.00% 0/71	0.00% 0/67	0.00% 0/65	0.00% 0/42	0.00% 0/42	2.3% 1/44
Immune system disorders ANAPHYLACTIC REACTION	1.4% 1/71	0.00% 0/67	0.00% 0/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Cardiac disorders ANGINA PECTORIS	0.00% 0/71	3.0% 2/67	0.00% 0/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Nervous system disorders CONVULSION	0.00% 0/71	0.00% 0/67	1.5% 1/65	2.4% 1/42	0.00% 0/42	2.3% 1/44
Vascular disorders DEEP VEIN THROMBOSIS	1.4% 1/71	0.00% 0/67	1.5% 1/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Gastrointestinal disorders DIARRHOEA	9.9% 7/71	7.5% 5/67	6.2% 4/65	2.4% 1/42	4.8% 2/42	2.3% 1/44
Gastrointestinal disorders DUODENAL ULCER	0.00% 0/71	0.00% 0/67	1.5% 1/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Gastrointestinal disorders ENTERITIS	1.4% 1/71	0.00% 0/67	0.00% 0/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Gastrointestinal disorders GASTROINTESTINAL PERFORATION	0.00% 0/71	0.00% 0/67	1.5% 1/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Nervous system disorders GRAND MAL CONVULSION	0.00% 0/71	0.00% 0/67	1.5% 1/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Investigations HEPATIC ENZYME INCREASED	0.00% 0/71	0.00% 0/67	0.00% 0/65	2.4% 1/42	0.00% 0/42	0.00% 0/44
Respiratory, thoracic and mediastinal disorders MEDIASTINAL DISORDER	0.00% 0/71	1.5% 1/67	0.00% 0/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Infections and infestations MENINGITIS	0.00% 0/71	1.5% 1/67	0.00% 0/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Neoplasms benign, malignant and unspecified (incl cysts and polyps) METASTASES TO CENTRAL NERVOUS SYSTEM	0.00% 0/71	0.00% 0/67	0.00% 0/65	2.4% 1/42	0.00% 0/42	0.00% 0/44
Cardiac disorders MYOCARDIAL INFARCTION	1.4% 1/71	0.00% 0/67	0.00% 0/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Gastrointestinal disorders OESOPHAGEAL DISORDER	0.00% 0/71	1.5% 1/67	0.00% 0/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Gastrointestinal disorders PANCREATITIS	0.00% 0/71	0.00% 0/67	0.00% 0/65	0.00% 0/42	0.00% 0/42	2.3% 1/44
Musculoskeletal and connective tissue disorders PATHOLOGICAL FRACTURE	0.00% 0/71	0.00% 0/67	1.5% 1/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Nervous system disorders PERIPHERAL SENSORIMOTOR NEUROPATHY	0.00% 0/71	0.00% 0/67	0.00% 0/65	2.4% 1/42	0.00% 0/42	0.00% 0/44
Respiratory, thoracic and mediastinal disorders PULMONARY HAEMORRHAGE	0.00% 0/71	0.00% 0/67	4.6% 3/65	2.4% 1/42	0.00% 0/42	0.00% 0/44
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SQUAMOUS CELL CARCINOMA	0.00% 0/71	0.00% 0/67	0.00% 0/65	2.4% 1/42	0.00% 0/42	0.00% 0/44
Vascular disorders VENOUS THROMBOSIS	0.00% 0/71	1.5% 1/67	0.00% 0/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Gastrointestinal disorders ABDOMINAL HERNIA	0.00% 0/71	1.5% 1/67	0.00% 0/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Nervous system disorders BASAL GANGLIA HAEMORRHAGE	0.00% 0/71	0.00% 0/67	0.00% 0/65	2.4% 1/42	0.00% 0/42	0.00% 0/44
Hepatobiliary disorders BILIARY COLIC	0.00% 0/71	0.00% 0/67	0.00% 0/65	0.00% 0/42	2.4% 1/42	0.00% 0/44
Cardiac disorders CARDIAC FAILURE CONGESTIVE	0.00% 0/71	0.00% 0/67	0.00% 0/65	0.00% 0/42	0.00% 0/42	2.3% 1/44
Cardiac disorders CARDIO-RESPIRATORY ARREST	0.00% 0/71	3.0% 2/67	0.00% 0/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
General disorders DEATH	2.8% 2/71	6.0% 4/67	3.1% 2/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Respiratory, thoracic and mediastinal disorders DYSPNOEA	5.6% 4/71	3.0% 2/67	3.1% 2/65	4.8% 2/42	2.4% 1/42	2.3% 1/44
Gastrointestinal disorders EROSIVE OESOPHAGITIS	0.00% 0/71	0.00% 0/67	1.5% 1/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
General disorders FATIGUE	1.4% 1/71	3.0% 2/67	1.5% 1/65	2.4% 1/42	2.4% 1/42	2.3% 1/44
Injury, poisoning and procedural complications FEMUR FRACTURE	1.4% 1/71	0.00% 0/67	0.00% 0/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Hepatobiliary disorders HEPATOTOXICITY	0.00% 0/71	0.00% 0/67	0.00% 0/65	2.4% 1/42	0.00% 0/42	0.00% 0/44
Metabolism and nutrition disorders HYPOKALAEMIA	1.4% 1/71	0.00% 0/67	1.5% 1/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Blood and lymphatic system disorders LEUKOPENIA	1.4% 1/71	0.00% 0/67	1.5% 1/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
General disorders LOCALISED OEDEMA	0.00% 0/71	1.5% 1/67	0.00% 0/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG NEOPLASM MALIGNANT	5.6% 4/71	6.0% 4/67	7.7% 5/65	9.5% 4/42	14.3% 6/42	11.4% 5/44
Nervous system disorders MONOPLEGIA	0.00% 0/71	1.5% 1/67	0.00% 0/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Nervous system disorders NEUROPATHY PERIPHERAL	1.4% 1/71	0.00% 0/67	0.00% 0/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Nervous system disorders PERIPHERAL MOTOR NEUROPATHY	0.00% 0/71	0.00% 0/67	1.5% 1/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Nervous system disorders PERIPHERAL SENSORY NEUROPATHY	0.00% 0/71	1.5% 1/67	1.5% 1/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Injury, poisoning and procedural complications PROCEDURAL PAIN	1.4% 1/71	0.00% 0/67	0.00% 0/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
General disorders SUDDEN DEATH	0.00% 0/71	3.0% 2/67	0.00% 0/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Congenital, familial and genetic disorders TRACHEO-OESOPHAGEAL FISTULA	0.00% 0/71	1.5% 1/67	0.00% 0/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Metabolism and nutrition disorders ACIDOSIS	1.4% 1/71	0.00% 0/67	0.00% 0/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Hepatobiliary disorders BILE DUCT STENOSIS	0.00% 0/71	0.00% 0/67	1.5% 1/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
General disorders DISEASE PROGRESSION	7.0% 5/71	1.5% 1/67	6.2% 4/65	2.4% 1/42	0.00% 0/42	2.3% 1/44
General disorders DROWNING	1.4% 1/71	0.00% 0/67	0.00% 0/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Gastrointestinal disorders GASTRITIS EROSIVE	0.00% 0/71	0.00% 0/67	1.5% 1/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Gastrointestinal disorders GASTROINTESTINAL HAEMORRHAGE	0.00% 0/71	1.5% 1/67	0.00% 0/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Injury, poisoning and procedural complications HIP FRACTURE	0.00% 0/71	0.00% 0/67	1.5% 1/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Vascular disorders HYPERTENSION	0.00% 0/71	0.00% 0/67	1.5% 1/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Metabolism and nutrition disorders HYPOCALCAEMIA	1.4% 1/71	0.00% 0/67	0.00% 0/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Metabolism and nutrition disorders HYPONATRAEMIA	1.4% 1/71	0.00% 0/67	1.5% 1/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Congenital, familial and genetic disorders ICHTHYOSIS	1.4% 1/71	0.00% 0/67	0.00% 0/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Infections and infestations LOBAR PNEUMONIA	1.4% 1/71	0.00% 0/67	0.00% 0/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Respiratory, thoracic and mediastinal disorders LUNG DISORDER	0.00% 0/71	0.00% 0/67	1.5% 1/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Nervous system disorders OCCIPITAL NEURALGIA	0.00% 0/71	1.5% 1/67	0.00% 0/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Infections and infestations PLEURAL INFECTION BACTERIAL	1.4% 1/71	0.00% 0/67	0.00% 0/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Infections and infestations PNEUMONIA	7.0% 5/71	3.0% 2/67	3.1% 2/65	0.00% 0/42	0.00% 0/42	4.5% 2/44
Gastrointestinal disorders RECTAL HAEMORRHAGE	1.4% 1/71	0.00% 0/67	0.00% 0/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Cardiac disorders VENTRICULAR FIBRILLATION	0.00% 0/71	0.00% 0/67	0.00% 0/65	0.00% 0/42	0.00% 0/42	2.3% 1/44

Other adverse events

Other adverse events
Measure	Ipilimubab+Paclitaxel/Carboplatin (Concurrent) NSCLC n=71 participants at risk During induction, participants with nonsmall-cell lung cancer (NSCLC) received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered intravenously (IV) as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered intravenously (IV) over 90 minutes every 12 weeks starting 24 weeks after the first dose until immune-related progressive disease (irPD), drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.	Placebo/Ipilimumab+ Paclitaxel/Carboplatin (Sequential) NSCLC n=67 participants at risk During induction, participants with NSCLC received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.	Placebo + Paclitaxel/Carboplatin NSCLC n=65 participants at risk During induction, participants with NSCLC received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.	Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) SCLC n=42 participants at risk During induction, participants with small-cell lung cancer (SCLC) received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.	Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential) SCLC n=42 participants at risk During induction, participants with SCLC received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until progressive disease, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.	Placebo + Paclitaxel/Carboplatin SCLC n=44 participants at risk During induction, participants with SCLC received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
Blood and lymphatic system disorders ANAEMIA	31.0% 22/71	22.4% 15/67	29.2% 19/65	31.0% 13/42	28.6% 12/42	22.7% 10/44
Musculoskeletal and connective tissue disorders ARTHRALGIA	25.4% 18/71	16.4% 11/67	15.4% 10/65	31.0% 13/42	54.8% 23/42	34.1% 15/44
Nervous system disorders DIZZINESS	12.7% 9/71	10.4% 7/67	7.7% 5/65	2.4% 1/42	4.8% 2/42	4.5% 2/44
Respiratory, thoracic and mediastinal disorders HYPOXIA	7.0% 5/71	1.5% 1/67	1.5% 1/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Gastrointestinal disorders NAUSEA	31.0% 22/71	40.3% 27/67	33.8% 22/65	26.2% 11/42	31.0% 13/42	29.5% 13/44
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	9.9% 7/71	13.4% 9/67	7.7% 5/65	11.9% 5/42	14.3% 6/42	9.1% 4/44
Gastrointestinal disorders ABDOMINAL PAIN UPPER	5.6% 4/71	4.5% 3/67	3.1% 2/65	2.4% 1/42	2.4% 1/42	2.3% 1/44
Investigations ALANINE AMINOTRANSFERASE INCREASED	5.6% 4/71	9.0% 6/67	3.1% 2/65	9.5% 4/42	9.5% 4/42	0.00% 0/44
Metabolism and nutrition disorders DECREASED APPETITE	18.3% 13/71	14.9% 10/67	16.9% 11/65	21.4% 9/42	19.0% 8/42	25.0% 11/44
Metabolism and nutrition disorders DEHYDRATION	5.6% 4/71	7.5% 5/67	4.6% 3/65	2.4% 1/42	4.8% 2/42	6.8% 3/44
Respiratory, thoracic and mediastinal disorders EPISTAXIS	2.8% 2/71	3.0% 2/67	7.7% 5/65	2.4% 1/42	4.8% 2/42	0.00% 0/44
Vascular disorders HYPOTENSION	5.6% 4/71	1.5% 1/67	12.3% 8/65	0.00% 0/42	4.8% 2/42	0.00% 0/44
Investigations WEIGHT DECREASED	14.1% 10/71	14.9% 10/67	7.7% 5/65	14.3% 6/42	16.7% 7/42	6.8% 3/44
Gastrointestinal disorders CONSTIPATION	18.3% 13/71	14.9% 10/67	23.1% 15/65	11.9% 5/42	9.5% 4/42	20.5% 9/44
Gastrointestinal disorders DYSPHAGIA	1.4% 1/71	7.5% 5/67	4.6% 3/65	2.4% 1/42	2.4% 1/42	4.5% 2/44
Skin and subcutaneous tissue disorders ERYTHEMA	5.6% 4/71	3.0% 2/67	1.5% 1/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Investigations HAEMOGLOBIN DECREASED	4.2% 3/71	7.5% 5/67	3.1% 2/65	0.00% 0/42	2.4% 1/42	0.00% 0/44
Nervous system disorders HEADACHE	11.3% 8/71	13.4% 9/67	12.3% 8/65	7.1% 3/42	23.8% 10/42	11.4% 5/44
Metabolism and nutrition disorders HYPERGLYCAEMIA	5.6% 4/71	3.0% 2/67	1.5% 1/65	2.4% 1/42	0.00% 0/42	2.3% 1/44
Skin and subcutaneous tissue disorders PRURITUS	19.7% 14/71	10.4% 7/67	6.2% 4/65	23.8% 10/42	21.4% 9/42	4.5% 2/44
General disorders PYREXIA	23.9% 17/71	16.4% 11/67	10.8% 7/65	14.3% 6/42	14.3% 6/42	11.4% 5/44
Skin and subcutaneous tissue disorders RASH	33.8% 24/71	13.4% 9/67	9.2% 6/65	38.1% 16/42	28.6% 12/42	6.8% 3/44
Cardiac disorders TACHYCARDIA	5.6% 4/71	1.5% 1/67	0.00% 0/65	0.00% 0/42	0.00% 0/42	6.8% 3/44
Gastrointestinal disorders VOMITING	26.8% 19/71	20.9% 14/67	20.0% 13/65	11.9% 5/42	11.9% 5/42	9.1% 4/44
General disorders ASTHENIA	19.7% 14/71	29.9% 20/67	16.9% 11/65	9.5% 4/42	16.7% 7/42	18.2% 8/44
General disorders CHILLS	5.6% 4/71	1.5% 1/67	9.2% 6/65	4.8% 2/42	2.4% 1/42	0.00% 0/44
Respiratory, thoracic and mediastinal disorders COUGH	22.5% 16/71	26.9% 18/67	18.5% 12/65	21.4% 9/42	19.0% 8/42	18.2% 8/44
Metabolism and nutrition disorders HYPERCALCAEMIA	5.6% 4/71	0.00% 0/67	3.1% 2/65	0.00% 0/42	0.00% 0/42	0.00% 0/44
Blood and lymphatic system disorders NEUTROPENIA	15.5% 11/71	22.4% 15/67	23.1% 15/65	26.2% 11/42	19.0% 8/42	13.6% 6/44
General disorders OEDEMA PERIPHERAL	11.3% 8/71	9.0% 6/67	9.2% 6/65	0.00% 0/42	7.1% 3/42	9.1% 4/44
Gastrointestinal disorders ABDOMINAL PAIN	5.6% 4/71	1.5% 1/67	12.3% 8/65	0.00% 0/42	9.5% 4/42	2.3% 1/44
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	5.6% 4/71	7.5% 5/67	4.6% 3/65	9.5% 4/42	11.9% 5/42	0.00% 0/44
General disorders CHEST PAIN	12.7% 9/71	11.9% 8/67	16.9% 11/65	9.5% 4/42	28.6% 12/42	20.5% 9/44
Skin and subcutaneous tissue disorders DRY SKIN	5.6% 4/71	7.5% 5/67	1.5% 1/65	2.4% 1/42	0.00% 0/42	2.3% 1/44
Respiratory, thoracic and mediastinal disorders HAEMOPTYSIS	8.5% 6/71	6.0% 4/67	6.2% 4/65	9.5% 4/42	7.1% 3/42	9.1% 4/44
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL PAIN	4.2% 3/71	10.4% 7/67	10.8% 7/65	2.4% 1/42	4.8% 2/42	13.6% 6/44
General disorders PAIN	9.9% 7/71	11.9% 8/67	10.8% 7/65	7.1% 3/42	14.3% 6/42	11.4% 5/44
Respiratory, thoracic and mediastinal disorders PRODUCTIVE COUGH	4.2% 3/71	0.00% 0/67	0.00% 0/65	9.5% 4/42	0.00% 0/42	0.00% 0/44
Blood and lymphatic system disorders THROMBOCYTOPENIA	14.1% 10/71	19.4% 13/67	18.5% 12/65	11.9% 5/42	14.3% 6/42	15.9% 7/44
Psychiatric disorders ANXIETY	2.8% 2/71	3.0% 2/67	10.8% 7/65	2.4% 1/42	2.4% 1/42	2.3% 1/44
Gastrointestinal disorders DIARRHOEA	29.6% 21/71	29.9% 20/67	21.5% 14/65	28.6% 12/42	33.3% 14/42	15.9% 7/44
Nervous system disorders DYSGEUSIA	9.9% 7/71	3.0% 2/67	4.6% 3/65	0.00% 0/42	4.8% 2/42	2.3% 1/44
Gastrointestinal disorders DYSPEPSIA	7.0% 5/71	1.5% 1/67	6.2% 4/65	2.4% 1/42	0.00% 0/42	2.3% 1/44
Metabolism and nutrition disorders HYPOMAGNESAEMIA	7.0% 5/71	1.5% 1/67	9.2% 6/65	2.4% 1/42	4.8% 2/42	2.3% 1/44
Musculoskeletal and connective tissue disorders BONE PAIN	7.0% 5/71	7.5% 5/67	9.2% 6/65	9.5% 4/42	9.5% 4/42	13.6% 6/44
Psychiatric disorders DEPRESSION	5.6% 4/71	3.0% 2/67	3.1% 2/65	0.00% 0/42	0.00% 0/42	4.5% 2/44
Respiratory, thoracic and mediastinal disorders DYSPHONIA	5.6% 4/71	3.0% 2/67	3.1% 2/65	2.4% 1/42	9.5% 4/42	2.3% 1/44
Respiratory, thoracic and mediastinal disorders DYSPNOEA	29.6% 21/71	16.4% 11/67	26.2% 17/65	38.1% 16/42	28.6% 12/42	38.6% 17/44
General disorders FATIGUE	36.6% 26/71	35.8% 24/67	36.9% 24/65	35.7% 15/42	35.7% 15/42	43.2% 19/44
Metabolism and nutrition disorders HYPOKALAEMIA	5.6% 4/71	9.0% 6/67	7.7% 5/65	2.4% 1/42	4.8% 2/42	0.00% 0/44
Blood and lymphatic system disorders LEUKOPENIA	8.5% 6/71	6.0% 4/67	10.8% 7/65	14.3% 6/42	9.5% 4/42	4.5% 2/44
Nervous system disorders NEUROPATHY PERIPHERAL	16.9% 12/71	14.9% 10/67	29.2% 19/65	14.3% 6/42	28.6% 12/42	11.4% 5/44
Respiratory, thoracic and mediastinal disorders OROPHARYNGEAL PAIN	0.00% 0/71	1.5% 1/67	6.2% 4/65	4.8% 2/42	4.8% 2/42	2.3% 1/44
Nervous system disorders PERIPHERAL MOTOR NEUROPATHY	1.4% 1/71	0.00% 0/67	4.6% 3/65	0.00% 0/42	7.1% 3/42	2.3% 1/44
Nervous system disorders PERIPHERAL SENSORY NEUROPATHY	9.9% 7/71	20.9% 14/67	13.8% 9/65	23.8% 10/42	35.7% 15/42	31.8% 14/44
Skin and subcutaneous tissue disorders ALOPECIA	38.0% 27/71	47.8% 32/67	47.7% 31/65	57.1% 24/42	69.0% 29/42	63.6% 28/44
Musculoskeletal and connective tissue disorders BACK PAIN	15.5% 11/71	9.0% 6/67	13.8% 9/65	4.8% 2/42	7.1% 3/42	6.8% 3/44
Metabolism and nutrition disorders HYPONATRAEMIA	4.2% 3/71	3.0% 2/67	6.2% 4/65	2.4% 1/42	2.4% 1/42	0.00% 0/44
Psychiatric disorders INSOMNIA	11.3% 8/71	7.5% 5/67	7.7% 5/65	4.8% 2/42	7.1% 3/42	4.5% 2/44
Musculoskeletal and connective tissue disorders MYALGIA	15.5% 11/71	13.4% 9/67	3.1% 2/65	7.1% 3/42	11.9% 5/42	11.4% 5/44
Infections and infestations PNEUMONIA	9.9% 7/71	1.5% 1/67	1.5% 1/65	7.1% 3/42	2.4% 1/42	0.00% 0/44
Gastrointestinal disorders STOMATITIS	1.4% 1/71	1.5% 1/67	0.00% 0/65	9.5% 4/42	2.4% 1/42	6.8% 3/44
Eye disorders VISION BLURRED	7.0% 5/71	3.0% 2/67	1.5% 1/65	0.00% 0/42	0.00% 0/42	0.00% 0/44

Additional Information

BMS Study Director

Bristol-Myers Squibb

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Publication restrictions are in place

Restriction type: OTHER