Trial · NCT02477826
An Investigational Immuno-therapy Trial of Nivolumab, or Nivolumab Plus Ipilimumab, or Nivolumab Plus Platinum-doublet Chemotherapy, Compared to Platinum Doublet Chemotherapy in Patients With Stage IV Non-Small Cell Lung Cancer (NSCLC)
NCT02477826, Phase 3, Completed, Bristol-Myers Squibb; results first posted 2025-10-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. An Investigational Immuno-therapy Trial of Nivolumab, or Nivolumab Plus Ipilimumab, or Nivolumab Plus Platinum-doublet Chemotherapy, Compared to Platinum Doublet Chemotherapy in Patients With Stage IV Non-Small Cell Lung Cancer (NSCLC). Trials, record NCT02477826. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02477826
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
An Investigational Immuno-therapy Trial of Nivolumab, or Nivolumab Plus Ipilimumab, or Nivolumab Plus Platinum-doublet Chemotherapy, Compared to Platinum Doublet Chemotherapy in Patients With Stage IV Non-Small Cell Lung Cancer (NSCLC)
- NCT number
- NCT02477826
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,747 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Non-Small Cell Lung Cancer
- Interventions
- Nivolumab, Ipilimumab, Carboplatin, Cisplatin, Gemcitabine, Pemetrexed, Paclitaxel
- First posted
- 2015-06-23
- Last updated
- 2025-10-30
- Other registries' IDs
- eudract:2014-003630-23
- Results first posted
- 2025-10-30
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival Per BICR | From randomization untill disease progression or death, whichever occurs first (up to approximately 481 weeks) | Progression-Free Survival then (PFS) is defined as the time between the date of randomization and the date of first documented disease progression, based on BICR assessments (per RECIST v1.1), or death due to any cause, whichever occurs first based on Kaplan-Meier estimates. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. |
| Primary | Overall Survival | From randomization untill death or last follow up whichever occurs first (up to approximately 481 weeks) | OS for all randomized participants is the time between randomization date and the date of death from any cause. |
| Secondary | Objective Response Rate (ORR) Per BICR | From randomization untill disease progression or death, whichever occurs first (up to approximately 481 weeks) | Objective response rate (ORR) is defined as the number of participants who achieve a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), based on blinded independent central review (BICR) assessments using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), divided by the number of all randomized participants. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\\< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
| Secondary | Percentage of Participants With Symptom Deterioration at Week 12 Assessed Via Lung Cancer Symptom Scale | Week 12 | The Lung Cancer Symptom Scale (LCSS) is a disease measure of quality of life which evaluates six major lung cancer symptoms and their effect on overall distress and symptom severity, impact on day-to-day activities, and overall quality of life. This patient reported outcome (PRO) questionnaire assesses the following 6 symptoms items (appetite loss, fatigue, cough, dyspnea, hemoptysis, pain) and 3 summary global items (symptom distress, activity level, overall quality of life) for patients using visual analogue scales (VAS) (100 mm horizontal line) ranging from 0 (best rating) to 100 (worst rating). The LCSS average total score is sum of items 1 to 9 divided by the total number of items ((sum of items 1 to 9)/9) ranging from 0 to 100 where high score represent worst outcome. Disease-Related Symptom Deterioration by Week 12 defined as a 10 points or more increase from baseline in LCSS average score at any time (on or off-treatment) up to 95 days from randomization date. |
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 | Progression-Free Survival Per BICR | From randomization untill disease progression or death, whichever occurs first (up to approximately 481 weeks) | All randomized participants | months | MEDIAN |
| PRIMARY | Overall Survival | From randomization untill death or last follow up whichever occurs first (up to approximately 481 weeks) | All randomized participants | months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) Per BICR | From randomization untill disease progression or death, whichever occurs first (up to approximately 481 weeks) | All randomized participants | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Symptom Deterioration at Week 12 Assessed Via Lung Cancer Symptom Scale | Week 12 | All randomized participants | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-Free Survival Per BICR | Part 1-Arm B: Nivo + Ipi | 5.06 | 95% Confidence Interval 4.07 to 6.31 | months | |
| Progression-Free Survival Per BICR | Part 1-Arm A: Nivolumab | 4.17 | 95% Confidence Interval 3.22 to 5.32 | months | |
| Progression-Free Survival Per BICR | Part 1-Arm C: Chemotherapy | 5.55 | 95% Confidence Interval 4.63 to 5.82 | months | |
| Progression-Free Survival Per BICR | Part 1-Arm D: Nivo + Ipi | 4.90 | 95% Confidence Interval 3.15 to 6.28 | months | |
| Progression-Free Survival Per BICR | Part 1-Arm G: Nivo + Chemo | 5.55 | 95% Confidence Interval 4.63 to 6.90 | months | |
| Progression-Free Survival Per BICR | Part 1-Arm F: Chemotherapy | 4.70 | 95% Confidence Interval 4.21 to 5.59 | months | |
| Progression-Free Survival Per BICR | Part 2 - Arm H: Nivolumab + Chemotherapy | 8.34 | 95% Confidence Interval 7.10 to 9.59 | months | |
| Progression-Free Survival Per BICR | Part 2 - Arm I: Chemotherapy | 5.52 | 95% Confidence Interval 4.47 to 5.85 | months | |
| Progression-Free Survival Per BICR | Part 3 -Arm J: Nivolumab + Ipilimumab | 5.78 | 95% Confidence Interval 4.14 to 8.34 | months | |
| Progression-Free Survival Per BICR | Part 3 - Arm K: Chemotherapy | 5.49 | 95% Confidence Interval 4.37 to 6.77 | months |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow60
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Pre-Treatment | STARTED | Part 1-Arm B: Nivo + Ipi | 396 | |
| Pre-Treatment | STARTED | Part 1-Arm A: Nivolumab | 396 | |
| Pre-Treatment | STARTED | Part 1-Arm C: Chemotherapy | 397 | |
| Pre-Treatment | STARTED | Part 1-Arm D: Nivo + Ipi | 187 | |
| Pre-Treatment | STARTED | Part 1-Arm G: Nivo + Chemo | 177 | |
| Pre-Treatment | STARTED | Part 1-Arm F: Chemotherapy | 186 | |
| Pre-Treatment | STARTED | Part 2 - Arm H: Nivolumab + Chemotherapy | 377 | |
| Pre-Treatment | STARTED | Part 2 - Arm I: Chemotherapy | 378 | |
| Pre-Treatment | STARTED | Part 3 -Arm J: Nivolumab + Ipilimumab | 126 | |
| Pre-Treatment | STARTED | Part 3 - Arm K: Chemotherapy | 127 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 participant flowAdverse events6,540
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 | Part 1-Arm B: Nivo + Ipi | 47 | 391 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 1-Arm A: Nivolumab | 51 | 391 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 1-Arm C: Chemotherapy | 159 | 387 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 1-Arm D: Nivo + Ipi | 25 | 185 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 1-Arm G: Nivo + Chemo | 80 | 172 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 1-Arm F: Chemotherapy | 76 | 183 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 2 - Arm H: Nivolumab + Chemotherapy | 174 | 375 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 2 - Arm I: Chemotherapy | 151 | 371 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 3 -Arm J: Nivolumab + Ipilimumab | 63 | 126 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 3 - Arm K: Chemotherapy | 93 | 123 |
1 to 10 of 6,540Source ClinicalTrials.gov
See all 6,540 adverse eventsAdverse event totals30
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part 1-Arm B: Nivo + Ipi | 316 | 391 |
| Total, all-cause mortality | Part 1-Arm A: Nivolumab | 333 | 391 |
| Total, all-cause mortality | Part 1-Arm C: Chemotherapy | 339 | 387 |
| Total, all-cause mortality | Part 1-Arm D: Nivo + Ipi | 159 | 185 |
| Total, all-cause mortality | Part 1-Arm G: Nivo + Chemo | 157 | 172 |
| Total, all-cause mortality | Part 1-Arm F: Chemotherapy | 174 | 183 |
| Total, all-cause mortality | Part 2 - Arm H: Nivolumab + Chemotherapy | 314 | 375 |
| Total, all-cause mortality | Part 2 - Arm I: Chemotherapy | 335 | 371 |
| Total, all-cause mortality | Part 3 -Arm J: Nivolumab + Ipilimumab | 95 | 126 |
| Total, all-cause mortality | Part 3 - Arm K: Chemotherapy | 94 | 123 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse event totalsPapers8
The papers the trial lists on ClinicalTrials.gov.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT02477826
GET https://conductscience.org/api/trials/v1/NCT02477826/results?page=2