Nivolumab in Combination With Ipilimumab (Part 1); Nivolumab Plus Ipilimumab in Combination With Chemotherapy (Part 2) as First Line Therapy in Stage IV Non-Small Cell Lung Cancer
CompletedPhase 2Results postedLast updated 5 April 2023
What this trial tests
Phase 2 trial testing Nivolumab in Non-Small-Cell Lung Cancer in 324 participants. Completed in 7 March 2022.
18 and older, any sex, with Non-Small-Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Objective Response Rate (ORR) by PD-L1 Positive and Negative Levels - Part 1Primary· From first dose to database lock (Up to 18 months)
Objective response rate (ORR) in PD-L1 positive (PD-L1 ≥1%) and PD-L1 negative (PD-L1 \<1%) participants was defined as the percentage of treated participants with confirmed complete response (CR) or partial response (PR) per RECIST 1.1 based on Blinded Independent Central Review (BICR) assessment.
PD-L1 ≥1%
Group
Value
95% CI
Nivolumab+Ipilimumab
41.3
33.0 – 50.0
PD-L1 <1%
Group
Value
95% CI
Nivolumab+Ipilimumab
14.9
8.9 – 22.8
Number of Participants With Dose Limiting Toxicities (DLTs) - Part 2Primary· 9 weeks after first dose
Dose limiting toxicities (DLTs) were defined as any of the items listed below.
1. Any Grade 2 drug-related uveitis or eye pain that does not respond to topical therapy and does not improve to Grade 1 severity within the re-treatment period OR requires systemic treatment.
2. Any Grade 2 drug-related pneumonitis or interstitial lung disease that does not resolve to dose delay and systemic steroids in 14 days.
3. Any Grade 3 non-skin drug-related adverse event with the exception of laboratory abnormalities that cannot be alleviated or controlled by appropriate care within 14 days.
4. Any Grade 4
Group
Value
95% CI
Nivolumab+Ipilimumab+Chemotherapy
1
Number of Participants With Adverse Events (AEs) - Part 2Primary· Deaths are from first dose to database lock (Up to 24 months). AEs and SAEs are from first dose to 30 days post last dose
Number of participants with adverse events (AEs) including serious adverse events (SAEs) and deaths graded by Common Terminology Criteria for Adverse Events (CTCAE v4.0) to determine the safety and tolerability of Nivolumab and Ipilimumab combined with chemotherapy.
Adverse Events (AEs)
Group
Value
95% CI
Nivolumab+Ipilimumab+Chemotherapy
36
Serious Adverse Events (SAEs)
Group
Value
95% CI
Nivolumab+Ipilimumab+Chemotherapy
26
Deaths due to Disease progression
Group
Value
95% CI
Nivolumab+Ipilimumab+Chemotherapy
9
Deaths due to Study drug toxicity
Group
Value
95% CI
Nivolumab+Ipilimumab+Chemotherapy
0
Deaths due to unknown causes
Group
Value
95% CI
Nivolumab+Ipilimumab+Chemotherapy
1
Deaths due to other causes
Group
Value
95% CI
Nivolumab+Ipilimumab+Chemotherapy
6
Number of Participants With Laboratory Abnormalities in Hepatic Tests - Part 2Primary· From first dose to 30 days post last dose
Number of participant with specific liver laboratory abnormalities graded by Common Terminology Criteria for Adverse Events (CTCAE v4.0) to determine the safety and tolerability of Nivolumab and Ipilimumab combined with chemotherapy.
ALT OR AST >3XULN
Group
Value
95% CI
Nivolumab+Ipilimumab+Chemotherapy
2
ALT OR AST >5XULN
Group
Value
95% CI
Nivolumab+Ipilimumab+Chemotherapy
2
ALT OR AST >10XULN
Group
Value
95% CI
Nivolumab+Ipilimumab+Chemotherapy
1
ALT OR AST >20XULN
Group
Value
95% CI
Nivolumab+Ipilimumab+Chemotherapy
1
TOTAL BILIRUBIN >2XULN
Group
Value
95% CI
Nivolumab+Ipilimumab+Chemotherapy
0
Concurrent ALT OR AST >3XULN & BILIRUBIN >2XULN within 1 day
Group
Value
95% CI
Nivolumab+Ipilimumab+Chemotherapy
0
Concurrent ALT OR AST >3XULN & BILIRUBIN >2XULN within 30 days
Group
Value
95% CI
Nivolumab+Ipilimumab+Chemotherapy
0
Number of Participants With Laboratory Abnormalities in Thyroid Tests - Part 2Primary· From first dose to 30 days post last dose
Number of participants with specific thyroid laboratory abnormalities graded by Common Terminology Criteria for Adverse Events (CTCAE v4.0) to determine the safety and tolerability of Nivolumab and Ipilimumab combined with chemotherapy.
TSH > ULN
Group
Value
95% CI
Nivolumab+Ipilimumab+Chemotherapy
10
TSH > ULN with TSH <= ULN at baseline
Group
Value
95% CI
Nivolumab+Ipilimumab+Chemotherapy
7
TSH > ULN with at least one FT3/FT4 test value < LLN
Group
Value
95% CI
Nivolumab+Ipilimumab+Chemotherapy
8
TSH > ULN with all other FT3/FT4 test values ≥ LLN
Group
Value
95% CI
Nivolumab+Ipilimumab+Chemotherapy
1
TSH > ULN with FT3/FT4 test missing
Group
Value
95% CI
Nivolumab+Ipilimumab+Chemotherapy
1
TSH < LLN
Group
Value
95% CI
Nivolumab+Ipilimumab+Chemotherapy
13
TSH < LLN with TSH >= LLN at baseline
Group
Value
95% CI
Nivolumab+Ipilimumab+Chemotherapy
12
TSH < LLN with at least one FT3/FT4 test value > ULN
Group
Value
95% CI
Nivolumab+Ipilimumab+Chemotherapy
7
Overall Survival (OS) - Part 1Secondary· From the date of first treatment to the date of death due to any cause (Up to approximately 72 months)
Overall survival (OS) was defined as the time from date of first treatment to the date of death due to any cause. A participant who has not died will be censored at the last known date alive.
Group
Value
95% CI
Nivolumab+Ipilimumab
20.83
14.46 – 25.20
Overall Survival (OS) - Part 2Secondary· From the date of first treatment to the date of death due to any cause (Up to approximately 59 months)
Overall survival (OS) was defined as the time from date of first treatment to the date of death due to any cause. A participant who has not died will be censored at the last known date alive.
Group
Value
95% CI
Nivolumab+Ipilimumab+Chemotherapy
19.35
6.54 – 35.42
Progression Free Survival (PFS) - Part 1Secondary· From first dose to the first date of documented progression, or death due to any cause, whichever occurred first (Up to approximately 72 months)
Progression Free Survival (PFS) was defined as the time between the date of first dose and the first date of documented progression, as determined by blinded independent central review (BICR), or death due to any cause, whichever occurred first. Progressive Disease (PD): 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.
Group
Value
95% CI
Nivolumab+Ipilimumab
5.19
3.06 – 5.82
Progression Free Survival (PFS) - Part 2Secondary· From first dose to the first date of documented progression, or death due to any cause, whichever occurred first (Up to approximately 59 months)
Progression Free Survival (PFS) was defined as the time between the date of first dose and the first date of documented progression, as determined by investigator (per RECIST 1.1), or death due to any cause, whichever occurred first. Progressive Disease (PD): 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.
Group
Value
95% CI
Nivolumab+Ipilimumab+Chemotherapy
10.81
5.26 – 16.13
Objective Response Rate (ORR) - Part 1Secondary· From first dose up to approximately 72 months
Objective response rate (ORR) was defined as the percentage of treated participants with confirmed complete response (CR) or partial response (PR) per RECIST 1.1 based on Blinded Independent Central Review (BICR) assessment.
CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) 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.
Group
Value
95% CI
Nivolumab+Ipilimumab
32.3
26.9 – 38.0
Objective Response Rate (ORR) - Part 2Secondary· From first dose up to approximately 59 months
Objective response rate (ORR) was defined as the percentage of treated participants with confirmed complete response (CR) or partial response (PR) per RECIST 1.1 based on investigator assessment.
CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) 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.
Group
Value
95% CI
Nivolumab+Ipilimumab+Chemotherapy
47.2
30.4 – 64.5
Overall Survival (OS) by PD-L1 Expression Levels - Part 1Secondary· From the date of first treatment to the date of death due to any cause (Up to approximately 72 months)
Overall survival (OS) by PD-L1 expression levels was defined as the time from date of first treatment to the date of death due to any cause. A participant who has not died will be censored at the last known date alive.
PD-L1 ≥1% = PD-L1 positive (membranous staining in ≥ 1% tumor cells) PD-L1 \<1% = PD-L1 negative (membranous staining in \<1% tumor cells)
PD-L1 ≥1%
Group
Value
95% CI
Nivolumab+Ipilimumab
26.51
17.12 – 43.17
PD-L1 <1%
Group
Value
95% CI
Nivolumab+Ipilimumab
13.70
10.71 – 21.91
Adverse events — posted to ClinicalTrials.gov
Time frame: Part 1: SAEs and AEs are assessed from first dose to 30 days post last dose (Up to approximately 25 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to approximately 72 months). Part 2: SAEs and AEs are assessed from first dose to 30 days post last dose (Up to approximately 25 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to approximately 59 months)..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Nivolumab+Ipilimumab
Serious: 171/288 (59%)
Deaths: 209/288
Nivolumab+Ipilimumab+Chemotherapy
Serious: 26/36 (72%)
Deaths: 28/36
Serious adverse events (162 terms)
Reaction
System
Nivolumab+Ipilimumab
Nivolumab+Ipilimumab+Chemo…
Pneumonia
Infections and infestations
—
—
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
The purpose of part 1 of this study is to determine the objective response rate (ORR) in stage IV NSCLC subjects treated with nivolumab in combination with ipilimumab as first line therapy.
The purpose of part 2 of this study is to determine the safety and tolerability of nivolumab and ipilimumab combined with a short course of chemotherapy in first line stage IV NSCLC.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07572123 — Evaluating the Addition of Maintenance Immunotherapy Compared to the Usual Treatment of Chemotherapy and Autologous Stem
· Phase 2, PHASE3
· not yet recruiting
NCT07444619 — A Phase I Study of Pazopanib in Combination With Trabectedin, Ipilimumab and Nivolumab (TraPIN) in Pediatric and Young A
· Phase 1
· not yet recruiting
NCT07383441 — Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer
· Phase 3
· not yet recruiting
NCT07420439 — Treatment in Patients With Advanced Non-Small Cell Lung Carcinoma and Interstitial Lung Disease
· Phase 2
· not yet recruiting
NCT07510334 — VSV-IFNβ-NIS With Ipilimumab and Nivolumab for the Treatment of Advanced or Metastatic Clear Cell Renal Cell Carcinoma
· Phase 2
· not yet recruiting
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NCT06476093 — SRT Combined With Anlotinib for the Treatment of Brain Metastases From Non-small Cell Lung Cancer
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NCT06343064 — Vebreltinib Plus PLB1004 in EGFR-mutated, Advanced NSCLC With MET Amplification or MET Overexpression Following EGFR-TKI
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Other Bristol-Myers Squibb trials
Trials by the same sponsor.
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NCT07459543 — A Study To Assess the Safety, and Tolerability of Nivolumab + Relatlimab Fixed-Dose Combination (FDC) In Untreated, Unre
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· not yet recruiting
NCT07285798 — A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism Spectrum Disorder
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NCT07284745 — A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bristol-Myers Squibb
Last refreshed: 5 April 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02659059.