Trial · NCT00527735
Outcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Immune-related Progression-free Survival (irPFS) in Participants With Nonsmall-cell Lung Cancer (NSCLC) Per Immune-related Response Criteria (irRC) | 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) | All participants with NSCLC who were randomized to a treatment group. | Months | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) in Participants With NSCLC Per Modified World Health Organization (mWHO) Criteria | Randomization date to date of progression or death (of censored, maximum reached: 13.6 months) | All NSCLC participants who were randomized to a treatment group. | Months | MEAN |
| SECONDARY | Overall Survival in Participants With NSCLC | Randomization date to date of death (of censored, maximum reached: 26.5 months) | All NSCLC participants who were randomized to a treatment group. | Months | MEDIAN |
| SECONDARY | Best Overall Response Rate (BORR) Per mWHO Criteria in Participants With NSCLC and SCLC | Tumor assessment at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance | All participants who were randomized to a treatment group. | Percentage of participants | NUMBER |
| SECONDARY | Immune-related Best Overall Response Rate (irBORR) Per irRC in Participants With NSCLC and Small-cell Lung Cancer (SCLC) | Tumor assessment at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance | All participants who were randomized to a treatment group. | Percentage of participants | NUMBER |
| SECONDARY | Immune-related Disease Control Rate (irDCR) Per irRC and Disease Control Rate (DCR) Per mWHO Criteria in Participants With NSCLC and SCLC | 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) | All participants who were randomized to a treatment group. | Percent of participants | NUMBER |
| SECONDARY | Immune-related Duration of Response (irDoR) Per irRC and DoR Per mWHO Criteria in Participants With NSCLC and SCLC | Date of irCR or irPR to date of irPD or death (maximum reached: 14.2 months) | All participants who were randomized to a treatment group. | Months | MEDIAN |
| SECONDARY | 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 | Weeks 4, 7, 10, 16, 19, and 24; at end of treatment; and at follow-up (70 days from last dose) | 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. | Participants | NUMBER |
| SECONDARY | Percentage of Participants With NSCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade | 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 | 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. | Percentage of participants | NUMBER |
| SECONDARY | irPFS in Participants With SCLC Per irRC | Randomization date to date of irPD or death (maximum reached: 22 months) | All participants with SCLC who were randomized to a treatment group. | Months | MEAN |
| SECONDARY | Number of Participants With NSCLC Who Have Abnormalities in On-Study Liver Function Test Results By Worst CTC Grade | 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 | 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. | Participants | NUMBER |
| SECONDARY | Number of Participants With NSCLC Who Had Abnormalities in Vital Sign Measurements and Physical Examination Findings | 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 | 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. | Participants | NUMBER |
| SECONDARY | Percentage of Participants With NSCLC Who Have Abnormalities in Pancreatic Enzyme Clinical Laboratory Test Results by Worst CTC Grade | At screening; predose Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and at end of treatment | 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. | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants With NSCLC Who Have Positive Human Antihuman Antibody (HAHA) Status Postbaseline | Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and at end of treatment | 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. | Participants | NUMBER |
| SECONDARY | 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 | Weeks 4, 7, 10, 16, 19, and 24; at end of treatment; and at follow-up (70 days from last dose) | All participants with SCLC who received at least 1 dose of blinded active or placebo ipilimumab with or without paclitaxel/carboplatin. | Participants | NUMBER |
| SECONDARY | Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade | At screening, predose Day 1, and Weeks 4, 7, 10, 13, 16, 19, 24, and at end of treatment | 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. | Participants | NUMBER |
| SECONDARY | Number of Participants With SCLC Who Have Abnormalities in Liver Function Test Results by Worst CTC Grade | At screening; predose Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and at end of treatment | 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. | Participants | NUMBER |
| SECONDARY | Percentage of Participants With SCLC Who Have Abnormalities in Pancreatic Enzyme and Other Clinical Laboratory Test Results by Worst CTC Grade | At screening, predose Day 1, and Weeks 4, 7, 10, 13, 16, 19, 24, and at end of treatment | 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. | Percentage of participants | NUMBER |
| SECONDARY | Progression-free Survival (PFS) in Participants With SCLC Per mWHO Criteria | Randomization date to date of progression or death (of censored, maximum reached: 22 months) | All participants with SCLC who were randomized to a treatment group. | Months | MEAN |
| SECONDARY | Number of Participants With SCLC Who Had Abnormalities in Vital Sign Measurements and Physical Examination Findings | Predose Day 1; Weeks 4, 7, 10, 13, 16, and 24; and every 12 weeks on maintenance until end of treatment | 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. | Participants | NUMBER |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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