Trial · NCT00527735
Phase II Study for Previously Untreated Subjects With Non Small Cell Lung Cancer (NSCLC) or Small Cell Lung Cancer (SCLC)
NCT00527735, Phase 2, Completed, Bristol-Myers Squibb; results first posted 2012-07-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase II Study for Previously Untreated Subjects With Non Small Cell Lung Cancer (NSCLC) or Small Cell Lung Cancer (SCLC). Trials, record NCT00527735. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00527735
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase II Study for Previously Untreated Subjects With Non Small Cell Lung Cancer (NSCLC) or Small Cell Lung Cancer (SCLC)
- NCT number
- NCT00527735
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 334 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Lung Cancer, Small Cell Lung Cancer, Carcinoma, Non-Small-Cell Lung
- Interventions
- Ipilimumab, Placebo, Paclitaxel, Carboplatin
- First posted
- 2007-09-11
- Last updated
- 2018-07-18
- Results first posted
- 2012-07-16
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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) | 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. |
| 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) | 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. |
| Secondary | Overall Survival in Participants With NSCLC | Randomization date to date of death (of censored, maximum reached: 26.5 months) | 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. |
| 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 | 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. |
| 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 | 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. |
| 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) | 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. |
| 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) | 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. |
| 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) | 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. |
| 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 | 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. |
| Secondary | irPFS in Participants With SCLC Per irRC | Randomization date to date of irPD or death (maximum reached: 22 months) | IRC performed TA. |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group339
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Immune-related Progression-free Survival (irPFS) in Participants With Nonsmall-cell Lung Cancer (NSCLC) Per Immune-related Response Criteria (irRC) | Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) | 5.52 | 95% Confidence Interval 4.17 to 6.74 | Months | |
| Immune-related Progression-free Survival (irPFS) in Participants With Nonsmall-cell Lung Cancer (NSCLC) Per Immune-related Response Criteria (irRC) | Ipilimumab + Paclitaxel/Carboplatin (Sequential) | 5.68 | 95% Confidence Interval 4.76 to 7.79 | Months | |
| Immune-related Progression-free Survival (irPFS) in Participants With Nonsmall-cell Lung Cancer (NSCLC) Per Immune-related Response Criteria (irRC) | Placebo + Paclitaxel/Carboplatin | 4.63 | 95% Confidence Interval 4.14 to 5.52 | Months | |
| Progression-free Survival (PFS) in Participants With NSCLC Per Modified World Health Organization (mWHO) Criteria | Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) | 4.11 | 95% Confidence Interval 2.76 to 5.32 | Months | |
| Progression-free Survival (PFS) in Participants With NSCLC Per Modified World Health Organization (mWHO) Criteria | Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential) | 5.13 | 95% Confidence Interval 4.17 to 5.72 | Months | |
| Progression-free Survival (PFS) in Participants With NSCLC Per Modified World Health Organization (mWHO) Criteria | Placebo + Paclitaxel/Carboplatin | 4.21 | 95% Confidence Interval 2.76 to 5.32 | Months | |
| Overall Survival in Participants With NSCLC | Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) | 9.69 | 95% Confidence Interval 7.59 to 12.48 | Months | |
| Overall Survival in Participants With NSCLC | Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential) | 12.22 | 95% Confidence Interval 9.26 to 14.39 | Months | |
| Overall Survival in Participants With NSCLC | Placebo + Paclitaxel/Carboplatin | 8.28 | 95% Confidence Interval 6.80 to 12.39 | Months | |
| Best Overall Response Rate (BORR) Per mWHO Criteria in Participants With NSCLC and SCLC | Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) | BORR (mWHO criteria) NSCLC cohort (n=70, 68, 66) | 21.4 | 95% Confidence Interval 12.5 to 32.29 | Percentage of participants |
1 to 10 of 339Source ClinicalTrials.gov
See all 339 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) | 113 | |
| Overall Study | STARTED | Ipilimumab + Paclitaxel/Carboplatin (Sequential) | 109 | |
| Overall Study | STARTED | Placebo + Paclitaxel/Carboplatin | 109 | |
| Overall Study | COMPLETED | Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) | 5 | |
| Overall Study | COMPLETED | Ipilimumab + Paclitaxel/Carboplatin (Sequential) | 2 | |
| Overall Study | COMPLETED | Placebo + Paclitaxel/Carboplatin | 2 | |
| Overall Study | NOT COMPLETED | Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) | 108 | |
| Overall Study | NOT COMPLETED | Ipilimumab + Paclitaxel/Carboplatin (Sequential) | 107 | |
| Overall Study | NOT COMPLETED | Placebo + Paclitaxel/Carboplatin | 107 |
Source ClinicalTrials.gov
Adverse events1,338
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | ANAEMIA | Blood and lymphatic system disorders | Ipilimubab+Paclitaxel/Carboplatin (Concurrent) NSCLC | 22 | 71 | |
| other | ANAEMIA | Blood and lymphatic system disorders | Placebo/Ipilimumab+ Paclitaxel/Carboplatin (Sequential) NSCLC | 15 | 67 | |
| other | ANAEMIA | Blood and lymphatic system disorders | Placebo + Paclitaxel/Carboplatin NSCLC | 19 | 65 | |
| other | ANAEMIA | Blood and lymphatic system disorders | Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) SCLC | 13 | 42 | |
| other | ANAEMIA | Blood and lymphatic system disorders | Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential) SCLC | 12 | 42 | |
| other | ANAEMIA | Blood and lymphatic system disorders | Placebo + Paclitaxel/Carboplatin SCLC | 10 | 44 | |
| other | ARTHRALGIA | Musculoskeletal and connective tissue disorders | Ipilimubab+Paclitaxel/Carboplatin (Concurrent) NSCLC | 18 | 71 | |
| other | ARTHRALGIA | Musculoskeletal and connective tissue disorders | Placebo/Ipilimumab+ Paclitaxel/Carboplatin (Sequential) NSCLC | 11 | 67 | |
| other | ARTHRALGIA | Musculoskeletal and connective tissue disorders | Placebo + Paclitaxel/Carboplatin NSCLC | 10 | 65 | |
| other | ARTHRALGIA | Musculoskeletal and connective tissue disorders | Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) SCLC | 13 | 42 |
1 to 10 of 1,338Source ClinicalTrials.gov
See all 1,338 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ipilimubab+Paclitaxel/Carboplatin (Concurrent) NSCLC | ||
| Total, all-cause mortality | Placebo/Ipilimumab+ Paclitaxel/Carboplatin (Sequential) NSCLC | ||
| Total, all-cause mortality | Placebo + Paclitaxel/Carboplatin NSCLC | ||
| Total, all-cause mortality | Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) SCLC | ||
| Total, all-cause mortality | Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential) SCLC | ||
| Total, all-cause mortality | Placebo + Paclitaxel/Carboplatin SCLC | ||
| Total, other adverse events | Ipilimubab+Paclitaxel/Carboplatin (Concurrent) NSCLC | 63 | 71 |
| Total, other adverse events | Placebo/Ipilimumab+ Paclitaxel/Carboplatin (Sequential) NSCLC | 63 | 67 |
| Total, other adverse events | Placebo + Paclitaxel/Carboplatin NSCLC | 59 | 65 |
| Total, other adverse events | Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) SCLC | 36 | 42 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) vs Ipilimumab + Paclitaxel/Carboplatin (Sequential): Number of Participants With NSCLC Who Have Positive Human Antihuman Antibody (HAHA) Status Postbaseline |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00527735
GET https://conductscience.org/api/trials/v1/NCT00527735/registered?page=2