Trial · NCT02481830
Effectiveness Study of Nivolumab Compared to Chemotherapy in Patients With Relapsed Small-cell Lung Cancer
NCT02481830, Phase 3, Completed, Bristol-Myers Squibb; results first posted 2020-01-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effectiveness Study of Nivolumab Compared to Chemotherapy in Patients With Relapsed Small-cell Lung Cancer. Trials, record NCT02481830. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02481830
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effectiveness Study of Nivolumab Compared to Chemotherapy in Patients With Relapsed Small-cell Lung Cancer
- NCT number
- NCT02481830
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 569 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Lung Cancer
- Interventions
- Nivolumab, Topotecan, Amrubicin
- First posted
- 2015-06-25
- Last updated
- 2023-07-27
- Other registries' IDs
- eudract:2015-001097-18
- Results first posted
- 2020-01-09
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) | OS was followed continuously while participants were on the study drug and every 3 months, minimum follow up for overall survival was 15.8 months | The time from randomization to the date of death, data was based on Kaplan-Meier Estimates. A participant who has not died will be censored at last known date alive. |
| Secondary | Progression Free Survival (PFS) | From randomization to the date of first documented tumor progression, or death due to any cause. Tumor response assessed every 6 weeks from first dose until week 30, and every 12 weeks (Up to approximately 80 months) | PFS is defined as the time from randomization to the date of the first documented tumor progression based on investigator assessment (per RECIST 1.1), or death due to any cause. Participants who die without a reported prior progression will be considered to have progressed on the date of their death. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment. Participants who did not have any on study tumor assessments and did not die will be censored on the date they were randomized. Participants who started any subsequent anti-cancer therapy without a prior reported progression will be censored at the last evaluable tumor assessment prior to initiation of the subsequent anti-cancer therapy. Progressive disease (PD)= At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. The sum must demonstrate an absolute increase of at least 5 mm. |
| Secondary | Objective Response Rate (ORR) | From randomization to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (Up to approximately 80 months) | ORR is defined as the percentage of randomized participants whose best overall response (BOR) from baseline is either a complete response (CR) or partial response (PR) based on investigator assessment per RECIST 1.1 criteria. For participants without documented progression or subsequent anti-cancer therapy, all available response designations will contribute to the BOR determination. For participants who continue nivolumab beyond progression, the BOR should be determined based on tumor assessments before initial RECIST 1.1 defined progression. CR= Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \<10 mm. PR= At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive disease (PD)= At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. The sum must demonstrate an absolute increase of at least 5 mm. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) | OS was followed continuously while participants were on the study drug and every 3 months, minimum follow up for overall survival was 15.8 months | All Randomized Participants | Months | MEDIAN |
| SECONDARY | Progression Free Survival (PFS) | From randomization to the date of first documented tumor progression, or death due to any cause. Tumor response assessed every 6 weeks from first dose until week 30, and every 12 weeks (Up to approximately 80 months) | All Randomized Participants | Months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) | From randomization to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (Up to approximately 80 months) | All Randomized Participants | Percentage of Participants | NUMBER |
| POST_HOC | Overall Survival (OS) - Extended Collection | OS was followed continuously while participants were on the study drug and every 3 months, minimum follow up for overall survival was 64 months (Up to approximately 80 months) | All Randomized Participants | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) | Group A | 7.46 | 95% Confidence Interval 5.65 to 9.20 | Months | |
| Overall Survival (OS) | Group B | 8.38 | 95% Confidence Interval 7.03 to 10.02 | Months | |
| Progression Free Survival (PFS) | Group A | 1.45 | 95% Confidence Interval 1.41 to 1.51 | Months | |
| Progression Free Survival (PFS) | Group B | 3.71 | 95% Confidence Interval 2.96 to 4.24 | Months | |
| Objective Response Rate (ORR) | Group A | 13.7 | 95% Confidence Interval 10.0 to 18.3 | Percentage of Participants | |
| Objective Response Rate (ORR) | Group B | 16.8 | 95% Confidence Interval 12.7 to 21.7 | Percentage of Participants | |
| Overall Survival (OS) - Extended Collection | Group A | 7.46 | 95% Confidence Interval 5.65 to 9.20 | Months | |
| Overall Survival (OS) - Extended Collection | Group B | 8.38 | 95% Confidence Interval 7.03 to 10.02 | Months |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Pre-treatment | STARTED | Group A | 284 | |
| Pre-treatment | STARTED | Group B | 285 | |
| Pre-treatment | COMPLETED | Group A | 282 | |
| Pre-treatment | COMPLETED | Group B | 265 | |
| Pre-treatment | NOT COMPLETED | Group A | 2 | |
| Pre-treatment | NOT COMPLETED | Group B | 20 | |
| Treatment | STARTED | Group A | 282 | |
| Treatment | STARTED | Group B | 265 | |
| Treatment | COMPLETED | Group A | 0 | |
| Treatment | COMPLETED | Group B | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events470
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 | Group A | 68 | 282 | |
| other | Anaemia | Blood and lymphatic system disorders | Group B | 163 | 265 | |
| other | Leukopenia | Blood and lymphatic system disorders | Group A | 12 | 282 | |
| other | Leukopenia | Blood and lymphatic system disorders | Group B | 41 | 265 | |
| other | Neutropenia | Blood and lymphatic system disorders | Group A | 17 | 282 | |
| other | Neutropenia | Blood and lymphatic system disorders | Group B | 93 | 265 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Group A | 19 | 282 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Group B | 78 | 265 | |
| other | Hypothyroidism | Endocrine disorders | Group A | 23 | 282 | |
| other | Hypothyroidism | Endocrine disorders | Group B | 1 | 265 |
1 to 10 of 470Source ClinicalTrials.gov
See all 470 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group A | 251 | 284 |
| Total, all-cause mortality | Group B | 256 | 285 |
| Total, other adverse events | Group A | 249 | 282 |
| Total, other adverse events | Group B | 248 | 265 |
| Total, serious adverse events | Group A | 183 | 282 |
| Total, serious adverse events | Group B | 171 | 265 |
Source ClinicalTrials.gov
Papers0
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Group A vs Group B: deaths from any cause | Trial comparisons |
| Group A vs Group B: serious adverse events | 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/NCT02481830
GET https://conductscience.org/api/trials/v1/NCT02481830/events?page=2