Trial · NCT02998528
A Neoadjuvant Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Versus Chemotherapy Alone in Early Stage Non-Small Cell Lung Cancer (NSCLC)
NCT02998528, Phase 3, Completed, Bristol-Myers Squibb; results first posted 2022-09-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Neoadjuvant Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Versus Chemotherapy Alone in Early Stage Non-Small Cell Lung Cancer (NSCLC). Trials, record NCT02998528. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02998528
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Neoadjuvant Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Versus Chemotherapy Alone in Early Stage Non-Small Cell Lung Cancer (NSCLC)
- NCT number
- NCT02998528
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 505 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Non Small Cell Lung Cancer
- Interventions
- Nivolumab, Cisplatin, Vinorelbine, Gemcitabine, Docetaxel, Pemetrexed, Carboplatin, Paclitaxel, Ipilimumab
- First posted
- 2016-12-20
- Last updated
- 2026-01-06
- Other registries' IDs
- eudract:2016-003536-21
- Results first posted
- 2022-09-28
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Event-Free Survival (EFS) | From randomization to disease progression, reoccurrence, or death due to any cause. (Up to a median of 30 months) | Event-free survival (EFS) is defined as the length of time from randomization to any of the following events: any progression of disease precluding surgery, progression or recurrence disease based on blinded independent central review (BICR) assessment per response evaluation criteria in solid tumors (RECIST) 1.1 after surgery, or death due to any cause. Participants who don't undergo surgery for reason other than progression will be considered to have an event at progression or death. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). |
| Primary | Pathologic Complete Response (pCR) Rate | From randomization up to a median of 30 months after randomization. | Pathologic complete response (pCR) rate is defined as the number of randomized participants with absence of residual tumor in lung and lymph nodes as evaluated by blinded independent pathological review (BIPR). |
| Secondary | Major Pathologic Response (MPR) Rate | From randomization up to a median of 30 months after randomization. | Major pathologic response (MPR) rate is defined as number of randomized participants with \</= 10% residual tumor in lung and lymph nodes as evaluated by blinded independent pathological review (BIPR). Viable tumors in situ carcinoma should not be included in MPR calculation. |
| Secondary | Overall Survival (OS) | From randomization to the date of death (Up to approximately 93 months) | Overall survival (OS) is defined as the time between the date of randomization and the date of death. OS will be censored on the last date a participant was known to be alive. |
| Secondary | Time to Death or Distant Metastases (TTDM) | From randomization to the first date of distant metastasis or the date of death in the absence of distant metastasis (Up to approximately 84 months) | TTDM is defined as the time between the date of randomization and the first date of distant metastasis or the date of death in the absence of distant metastasis. Distant metastasis is defined as any new lesion that is outside of the thorax using blinded independent central review (BICR) according to response evaluation criteria in solid tumors (RECIST) 1.1. Patients who have not developed distant metastasis or died at the time of analysis will be censored on the date of their last evaluable tumor assessment. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Event-Free Survival (EFS) | From randomization to disease progression, reoccurrence, or death due to any cause. (Up to a median of 30 months) | All concurrently randomized participants in Arm C and Arm B | Months | MEDIAN |
| PRIMARY | Pathologic Complete Response (pCR) Rate | From randomization up to a median of 30 months after randomization. | All concurrently randomized participants in Arm C and Arm B | Participants | COUNT_OF_PARTICIPANTS |
| POST_HOC | Event-Free Survival (EFS) | From randomization to disease progression, reoccurrence, or death due to any cause. (Up to a median of 69 months) | All concurrently randomized participants in Arm C and Arm B | Months | MEDIAN |
| SECONDARY | Major Pathologic Response (MPR) Rate | From randomization up to a median of 30 months after randomization. | All concurrently randomized participants in Arm C and Arm B | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Survival (OS) | From randomization to the date of death (Up to approximately 93 months) | All concurrently randomized participants in Arm C and Arm B | Months | MEDIAN |
| SECONDARY | Time to Death or Distant Metastases (TTDM) | From randomization to the first date of distant metastasis or the date of death in the absence of distant metastasis (Up to approximately 84 months) | All concurrently randomized participants in Arm C and Arm B | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Event-Free Survival (EFS) | Arm B: Platinum Doublet Chemo | 20.80 | 95% Confidence Interval 14.03 to 26.71 | Months | |
| Event-Free Survival (EFS) | Arm C: Nivo 360 mg + Platinum Doublet Chemo | 31.57 | 95% Confidence Interval 30.16 to NA | Months | |
| Pathologic Complete Response (pCR) Rate | Arm B: Platinum Doublet Chemo | 4 | Participants | ||
| Pathologic Complete Response (pCR) Rate | Arm C: Nivo 360 mg + Platinum Doublet Chemo | 43 | Participants | ||
| Event-Free Survival (EFS) | Arm B: Platinum Doublet Chemo | 21.06 | 95% Confidence Interval 16.53 to 36.76 | Months | |
| Event-Free Survival (EFS) | Arm C: Nivo 360 mg + Platinum Doublet Chemo | 59.60 | 95% Confidence Interval 31.57 to NA | Months | |
| Major Pathologic Response (MPR) Rate | Arm B: Platinum Doublet Chemo | 16 | Participants | ||
| Major Pathologic Response (MPR) Rate | Arm C: Nivo 360 mg + Platinum Doublet Chemo | 66 | Participants | ||
| Overall Survival (OS) | Arm B: Platinum Doublet Chemo | 73.72 | 95% Confidence Interval 47.34 to NA | Months | |
| Overall Survival (OS) | Arm C: Nivo 360 mg + Platinum Doublet Chemo | NA | 95% Confidence Interval NA to NA | Months |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow33
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Randomization Period | STARTED | Arm A: Nivo 3 mg/kg + Ipi 1 mg/kg | 113 | |
| Randomization Period | STARTED | Arm B: Platinum Doublet Chemo | 213 | |
| Randomization Period | STARTED | Arm C: Nivo 360 mg + Platinum Doublet Chemo | 179 | |
| Randomization Period | All Concurrently Randomized Participants in Arms B and C | Arm A: Nivo 3 mg/kg + Ipi 1 mg/kg | 0 | |
| Randomization Period | All Concurrently Randomized Participants in Arms B and C | Arm B: Platinum Doublet Chemo | 179 | |
| Randomization Period | All Concurrently Randomized Participants in Arms B and C | Arm C: Nivo 360 mg + Platinum Doublet Chemo | 179 | |
| Randomization Period | COMPLETED | Arm A: Nivo 3 mg/kg + Ipi 1 mg/kg | 112 | |
| Randomization Period | COMPLETED | Arm B: Platinum Doublet Chemo | 207 | |
| Randomization Period | COMPLETED | Arm C: Nivo 360 mg + Platinum Doublet Chemo | 176 | |
| Randomization Period | NOT COMPLETED | Arm A: Nivo 3 mg/kg + Ipi 1 mg/kg | 1 |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 participant flowAdverse events531
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 | Arm A: Nivo 3 mg/kg + Ipi 1 mg/kg | 9 | 111 | |
| other | Anaemia | Blood and lymphatic system disorders | Arm B: Platinum Doublet Chemo | 78 | 208 | |
| other | Anaemia | Blood and lymphatic system disorders | Arm C: Nivo 360 mg + Platinum Doublet Chemo | 62 | 176 | |
| other | Leukopenia | Blood and lymphatic system disorders | Arm A: Nivo 3 mg/kg + Ipi 1 mg/kg | 0 | 111 | |
| other | Leukopenia | Blood and lymphatic system disorders | Arm B: Platinum Doublet Chemo | 17 | 208 | |
| other | Leukopenia | Blood and lymphatic system disorders | Arm C: Nivo 360 mg + Platinum Doublet Chemo | 18 | 176 | |
| other | Neutropenia | Blood and lymphatic system disorders | Arm A: Nivo 3 mg/kg + Ipi 1 mg/kg | 1 | 111 | |
| other | Neutropenia | Blood and lymphatic system disorders | Arm B: Platinum Doublet Chemo | 39 | 208 | |
| other | Neutropenia | Blood and lymphatic system disorders | Arm C: Nivo 360 mg + Platinum Doublet Chemo | 32 | 176 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Arm A: Nivo 3 mg/kg + Ipi 1 mg/kg | 0 | 111 |
1 to 10 of 531Source ClinicalTrials.gov
See all 531 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A: Nivo 3 mg/kg + Ipi 1 mg/kg | 46 | 112 |
| Total, all-cause mortality | Arm B: Platinum Doublet Chemo | 105 | 214 |
| Total, all-cause mortality | Arm C: Nivo 360 mg + Platinum Doublet Chemo | 66 | 179 |
| Total, other adverse events | Arm A: Nivo 3 mg/kg + Ipi 1 mg/kg | 102 | 111 |
| Total, other adverse events | Arm B: Platinum Doublet Chemo | 202 | 208 |
| Total, other adverse events | Arm C: Nivo 360 mg + Platinum Doublet Chemo | 160 | 176 |
| Total, serious adverse events | Arm A: Nivo 3 mg/kg + Ipi 1 mg/kg | 30 | 111 |
| Total, serious adverse events | Arm B: Platinum Doublet Chemo | 58 | 208 |
| Total, serious adverse events | Arm C: Nivo 360 mg + Platinum Doublet Chemo | 53 | 176 |
Source ClinicalTrials.gov
Papers6
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm B: Platinum Doublet Chemo vs Arm C: Nivo 360 mg + Platinum Doublet Chemo: Major Pathologic Response (MPR) Rate | Trial comparisons |
| Arm B: Platinum Doublet Chemo vs Arm C: Nivo 360 mg + Platinum Doublet Chemo: Pathologic Complete Response (pCR) Rate | 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/NCT02998528
GET https://conductscience.org/api/trials/v1/NCT02998528/flow?page=2