Phase 2
N=324
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
Non-Small-Cell Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02659059 ↗Enrolled (actual)
324
Serious AEs
60.8%
Results posted
Jul 2021
Primary outcome: Primary: Objective Response Rate (ORR) by PD-L1 Positive and Negative Levels - Part 1 — 41.3; 14.9 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Nivolumab (Biological); Ipilimumab (Biological); Platinum Doublet Chemotherapy (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate (ORR) by PD-L1 Positive and Negative Levels - Part 1 |
41.3; 14.9 | — |
| PRIMARY Number of Participants With Dose Limiting Toxicities (DLTs) - Part 2 |
1 | — |
| PRIMARY Number of Participants With Adverse Events (AEs) - Part 2 |
36; 26; 9; 0; 1; 6 | — |
| PRIMARY Number of Participants With Laboratory Abnormalities in Hepatic Tests - Part 2 |
2; 2; 1; 1; 0; 0 | — |
| PRIMARY Number of Participants With Laboratory Abnormalities in Thyroid Tests - Part 2 |
10; 7; 8; 1; 1; 13 | — |
| SECONDARY Overall Survival (OS) - Part 1 |
20.83 | — |
| SECONDARY Overall Survival (OS) - Part 2 |
19.35 | — |
| SECONDARY Progression Free Survival (PFS) - Part 1 |
5.19 | — |
| SECONDARY Progression Free Survival (PFS) - Part 2 |
10.81 | — |
| SECONDARY Objective Response Rate (ORR) - Part 1 |
32.3 | — |
| SECONDARY Objective Response Rate (ORR) - Part 2 |
47.2 | — |
| SECONDARY Overall Survival (OS) by PD-L1 Expression Levels - Part 1 |
26.51; 13.70 | — |
| SECONDARY Progression Free Survival (PFS) by PD-L1 Expression Levels - Part 1 |
6.80; 2.92 | — |
| SECONDARY Objective Response Rate (ORR) by PD-L1 Expression Levels-Part 1 |
44.2; 17.1 | — |
| SECONDARY Overall Survival (OS) by Tumor Mutation Burden (TMB) Levels - Part 1 |
47.31; 11.33 | — |
| SECONDARY Progression Free Survival (PFS) by Tumor Mutation Burden (TMB) Levels - Part 1 |
10.84; 2.79 | — |
| SECONDARY Objective Response Rate (ORR) by Tumor Mutation Burden (TMB) Levels - Part 1 |
52.1; 16.0 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Men and Women ≥ 18 years of age
- Diagnosed with stage IV Non-Small Cell Lung Cancer
- Diagnosed with recurrent stage IIIB non-small cell lung cancer and failed previous concurrent chemoradiation with no further curative options.
Exclusion Criteria
- Subjects with untreated CNS metastases are excluded.
- Subjects with carcinomatous meningitis
- Subjects with an active, known or suspected autoimmune disease.
- Subjects with a condition requiring systemic treatment with either corticosteroids ( > 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first treatment.
- Women who are pregnant, plan to become pregnant, and/or breastfeed during the study.
Other protocol defined inclusion/exclusion criteria apply
Data sourced from ClinicalTrials.gov (NCT02659059). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.