Clinical trial · Interventional
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
A Study of Nivolumab in Combination With Ipilimumab (Part 1); and Nivolumab Plus Ipilimumab in Combination With Chemotherapy (Part 2) as First Line Therapy in Stage IV Non-Small Cell Lung Cancer (NSCLC)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small-Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ipilimumab | Biological | Ipilimumab | ALIAS |
| Nivolumab | Biological | Nivolumab | ALIAS |
| Platinum Doublet Chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Nivolumab+Ipilimumab
- description
- Part 1 Specified Dose on Specified Days
- interventionNames
- Biological: Nivolumab
- Biological: Ipilimumab
- type
- EXPERIMENTAL
- label
- Nivolumab+Ipilimumab + 2 cycles Platinum Doublet Chemotherapy
- description
- Part 2 Specified Dose on Specified Days
- interventionNames
- Biological: Nivolumab
- Biological: Ipilimumab
- Drug: Platinum Doublet Chemotherapy
Primary outcomes (5)
- measure
- Objective Response Rate (ORR) by PD-L1 Positive and Negative Levels - Part 1
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDReady N, Hellmann MD, Awad MM, Otterson GA, Gutierrez M, Gainor JF, Borghaei H, Jolivet J, Horn L, Mates M, Brahmer J, Rabinowitz I, Reddy PS, Chesney J, Orcutt J, Spigel DR, Reck M, O'Byrne KJ, Paz-Ares L, Hu W, Zerba K, Li X, Lestini B, Geese WJ, Szustakowski JD, Green G, Chang H, Ramalingam SS. First-Line Nivolumab Plus Ipilimumab in Advanced Non-Small-Cell Lung Cancer (CheckMate 568): Outcomes by Programmed Death Ligand 1 and Tumor Mutational Burden as Biomarkers. J Clin Oncol. 2019 Apr 20;37(12):992-1000. doi: 10.1200/JCO.18.01042. Epub 2019 Feb 20. PMID 30785829