Trial · NCT04623775
A Study of Relatlimab Plus Nivolumab in Combination With Chemotherapy vs. Nivolumab in Combination With Chemotherapy as First Line Treatment for Participants With Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC)
NCT04623775, Phase 2, Completed, Bristol-Myers Squibb; results first posted 2025-03-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Relatlimab Plus Nivolumab in Combination With Chemotherapy vs. Nivolumab in Combination With Chemotherapy as First Line Treatment for Participants With Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC). Trials, record NCT04623775. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04623775
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Study of Relatlimab Plus Nivolumab in Combination With Chemotherapy vs. Nivolumab in Combination With Chemotherapy as First Line Treatment for Participants With Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC)
- NCT number
- NCT04623775
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 468 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Non-small Cell Lung Cancer, Recurrent Non-small Cell Lung Cancer, Metastatic Non-small Cell Lung Cancer
- Interventions
- Nivolumab, Relatlimab, Carboplatin, Cisplatin, Paclitaxel, Nab-Paclitaxel, Pemetrexed
- First posted
- 2020-11-10
- Last updated
- 2026-06-18
- Other registries' IDs
- eudract:2020-004026-31
- Results first posted
- 2025-03-18
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | TRAEs Leading to Discontinuation Within 12 Weeks of First Dose in Part 1 | from first dose to 12 weeks after first dose | Percentage of participants with treatment related adverse events (TRAEs) leading to discontinuation within 12 weeks of first dose. AE is defined as any new untoward medical occurrence or worsenig of a preexising medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Grading will be determined for severity according to the NCI CTCAE v5.0. |
| Primary | ORR Per RECISTS v1.1 by BICR in Part 2 | Approximately 14.8 Months | Objective Response Rate (ORR) per RECIST v1.1 by BICR is defined as the number of participants in the randomized population who achieve a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) based on BICR assessments (using RECIST v1.1) divided by the number of participants in the population. BOR is defined as the best response, as determined by the BICR, recorded between the date of randomization and the date of first objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurs first. |
| Secondary | TRAEs Leading to Discontinuation in Part 1 | From first dose to 30 days post last dose of study therapy (Approximately 32.8 Months) | Number of participants with treatment related adverse events (TRAEs) leading to discontinuation based on grade. AE is defined as any new untoward medical occurrence or worsenig of a preexising medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Grading will be determined for severity according to the NCI CTCAE v5.0 |
| Secondary | Number of Participants With a Treatment Related AEs in Part 1 | From first dose to 30 days post last dose of study therapy (Approximately 32.8 Months) | Number of participants with a treatment related AE in part 1. AE is defined as any new untoward medical occurrence or worsenig of a preexising medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Grading will be determined for severity according to the NCI CTCAE v5.0 |
| Secondary | Number of Participants With Treatment Releted SAEs in Part 1 | From first dose to 30 days post last dose of study therapy (Approximately 32.8 Months) | A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose, results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event (defined as a medical event(s) that may not be immediately life-threatening or result in death or hospitalization but, based upon appropriate medical and scientific judgment, may jeopardize the participant or may require intervention \[e.g., medical, surgical\] to prevent one of the other serious outcomes listed in the definition). Grading will be determined for severity according to the NCI CTCAE v5.0. |
| Secondary | Number of Participants With Treatment Releted Select AEs in Part 1 | From first dose to 30 days post last dose of study therapy (Approximately 32.8 Months) | AE is defined as any new untoward medical occurrence or worsenig of a preexising medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Select Adverse Events (AEs) will be determined for severity according to the NCI CTCAE v5.0. |
| Secondary | ORR by PD-L1 Expression Per RECISTS v1.1 by BICR in Part 2 | Approximately 14.8 Months | Objective Response Rate (ORR) per RECIST v1.1 by BICR is defined as the number of participants in the randomized population who achieve a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) based on BICR assessments (using RECIST v1.1) divided by the number of participants in the population. BOR is defined as the best response, as determined by the BICR, recorded between the date of randomization and the date of first objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurs first. |
| Secondary | DoR Per RECISTS v1.1 by BICR in Part 2 | Approximately up to 13.7 months | Duration of Response (DOR) will be assessed by BICR. It is defined as the time between the date of first documented response (CR or PR) that is subsequently confirmed, to the date of the first objectively documented tumor progression as determined by the BICR (per RECIST v1.1), or death due to any cause, whichever occurs first. |
| Secondary | Number of Participants With a AE in Part 2 | From first dose to 30 days post last dose of study therapy (Approximately 14.8 Months) | Number of participants with an adverse event (AE). AE is defined as any new untoward medical occurrence or worsenig of a preexising medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Grading will be determined for severity according to the NCI CTCAE v5.0. |
| Secondary | Number of Participants With a Treatment Related AEs in Part 2 | From first dose to 30 days post last dose of study therapy (Approximately 14.8 Months) | AE is defined as any new untoward medical occurrence or worsenig of a preexising medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Grading will be determined for severity according to the NCI CTCAE v5.0. |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | TRAEs Leading to Discontinuation Within 12 Weeks of First Dose in Part 1 | from first dose to 12 weeks after first dose | All Treated Dose-Safety Evaluable participants in part 1 | Percentage of Participants | NUMBER |
| PRIMARY | ORR Per RECISTS v1.1 by BICR in Part 2 | Approximately 14.8 Months | All randomized participants in Part 2 | Percentage of Participants | NUMBER |
| SECONDARY | TRAEs Leading to Discontinuation in Part 1 | From first dose to 30 days post last dose of study therapy (Approximately 32.8 Months) | All treated participants in Part 1 | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With a Treatment Related AEs in Part 1 | From first dose to 30 days post last dose of study therapy (Approximately 32.8 Months) | All treated participants in Part 1 | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Treatment Releted SAEs in Part 1 | From first dose to 30 days post last dose of study therapy (Approximately 32.8 Months) | All treated participants in Part 1 | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Treatment Releted Select AEs in Part 1 | From first dose to 30 days post last dose of study therapy (Approximately 32.8 Months) | All treated participants in Part 1 | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | ORR by PD-L1 Expression Per RECISTS v1.1 by BICR in Part 2 | Approximately 14.8 Months | All randomized participants in Part 2 | Percentage of Participants | NUMBER |
| SECONDARY | DoR Per RECISTS v1.1 by BICR in Part 2 | Approximately up to 13.7 months | All randomized participants in Part 2 | Months | MEDIAN |
| SECONDARY | Number of Participants With a AE in Part 2 | From first dose to 30 days post last dose of study therapy (Approximately 14.8 Months) | All treated participants in Part 2 | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With a Treatment Related AEs in Part 2 | From first dose to 30 days post last dose of study therapy (Approximately 14.8 Months) | All treated participants in Part 2 | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group70
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| TRAEs Leading to Discontinuation Within 12 Weeks of First Dose in Part 1 | Part 1: Treatment A | 5.6 | 95% Confidence Interval 1.6 to 13.8 | Percentage of Participants | |
| TRAEs Leading to Discontinuation Within 12 Weeks of First Dose in Part 1 | Part 1: Treatment B | 12.1 | 95% Confidence Interval 5.4 to 22.5 | Percentage of Participants | |
| ORR Per RECISTS v1.1 by BICR in Part 2 | Part 2: Treatment C | 50.6 | 90% Confidence Interval 43.8 to 57.4 | Percentage of Participants | |
| ORR Per RECISTS v1.1 by BICR in Part 2 | Part 2: Treatment D | 43.0 | 90% Confidence Interval 36.2 to 50.1 | Percentage of Participants | |
| TRAEs Leading to Discontinuation in Part 1 | Part 1: Treatment A | Any Grade | 21 | Participants | |
| TRAEs Leading to Discontinuation in Part 1 | Part 1: Treatment B | Any Grade | 18 | Participants | |
| TRAEs Leading to Discontinuation in Part 1 | Part 1: Treatment A | Grade 3 to 4 | 13 | Participants | |
| TRAEs Leading to Discontinuation in Part 1 | Part 1: Treatment B | Grade 3 to 4 | 12 | Participants | |
| TRAEs Leading to Discontinuation in Part 1 | Part 1: Treatment A | Grade 5 | 1 | Participants | |
| TRAEs Leading to Discontinuation in Part 1 | Part 1: Treatment B | Grade 5 | 0 | Participants |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Randomization | STARTED | Part 1: Treatment A | 79 | |
| Randomization | STARTED | Part 1: Treatment B | 80 | |
| Randomization | STARTED | Part 2: Treatment C | 158 | |
| Randomization | STARTED | Part 2: Treatment D | 151 | |
| Randomization | COMPLETED | Part 1: Treatment A | 77 | |
| Randomization | COMPLETED | Part 1: Treatment B | 79 | |
| Randomization | COMPLETED | Part 2: Treatment C | 158 | |
| Randomization | COMPLETED | Part 2: Treatment D | 149 | |
| Randomization | NOT COMPLETED | Part 1: Treatment A | 2 | |
| Randomization | NOT COMPLETED | Part 1: Treatment B | 1 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events1,136
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: Treatment A | 51 | 77 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 1: Treatment B | 43 | 79 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 2: Treatment C | 109 | 158 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 2: Treatment D | 92 | 149 | |
| other | Eosinophilia | Blood and lymphatic system disorders | Part 1: Treatment A | 4 | 77 | |
| other | Eosinophilia | Blood and lymphatic system disorders | Part 1: Treatment B | 0 | 79 | |
| other | Eosinophilia | Blood and lymphatic system disorders | Part 2: Treatment C | 3 | 158 | |
| other | Eosinophilia | Blood and lymphatic system disorders | Part 2: Treatment D | 3 | 149 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Part 1: Treatment A | 1 | 77 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Part 1: Treatment B | 1 | 79 |
1 to 10 of 1,136Source ClinicalTrials.gov
See all 1,136 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part 1: Treatment A | 47 | 77 |
| Total, all-cause mortality | Part 1: Treatment B | 46 | 79 |
| Total, all-cause mortality | Part 2: Treatment C | 79 | 158 |
| Total, all-cause mortality | Part 2: Treatment D | 70 | 149 |
| Total, other adverse events | Part 1: Treatment A | 74 | 77 |
| Total, other adverse events | Part 1: Treatment B | 78 | 79 |
| Total, other adverse events | Part 2: Treatment C | 151 | 158 |
| Total, other adverse events | Part 2: Treatment D | 145 | 149 |
| Total, serious adverse events | Part 1: Treatment A | 46 | 77 |
| Total, serious adverse events | Part 1: Treatment B | 52 | 79 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42918419 | DERIVED |
Source PubMed
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 |
|---|
| Part 1: Treatment A vs Part 1: Treatment B: Number of Participants With a Treatment Related AEs in Part 1 |
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.
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