Trial results for study NCT02477826, investigating nivolumab in various combinations for patients with Stage IV Non-Small Cell Lung Cancer (NSCLC), were posted on ClinicalTrials.gov on 2025-10-30. Among the findings, the combination of nivolumab plus chemotherapy demonstrated a median progression-free survival of 8.34 months compared to 5.52 months for chemotherapy alone in one part of the study.
Background
The study investigated nivolumab in patients with Stage IV Non-Small Cell Lung Cancer (NSCLC). The trial aimed to compare the efficacy of nivolumab alone, nivolumab plus ipilimumab, or nivolumab plus platinum-doublet chemotherapy against platinum-doublet chemotherapy alone.
Trial design
The study NCT02477826 was a Phase 3, multi-arm trial that enrolled 2747 participants with Stage IV Non-Small Cell Lung Cancer (NSCLC). The trial evaluated several treatment arms: nivolumab monotherapy, nivolumab plus ipilimumab, and nivolumab plus platinum-doublet chemotherapy (using agents such as carboplatin, cisplatin, and gemcitabine), compared to platinum-doublet chemotherapy alone.
Key results
The trial reported several outcome measurements for progression-free survival (PFS) per Blinded Independent Central Review (BICR) and overall survival (OS) across different treatment arms:
- For "Progression-Free Survival Per BICR":
- Part 1-Arm B: Nivo + Ipi showed a median PFS of 5.06 months.
- Part 1-Arm A: Nivolumab showed a median PFS of 4.17 months.
- Part 1-Arm C: Chemotherapy showed a median PFS of 5.55 months.
- Part 1-Arm D: Nivo + Ipi showed a median PFS of 4.90 months.
- Part 1-Arm G: Nivo + Chemo showed a median PFS of 5.55 months.
- Part 1-Arm F: Chemotherapy showed a median PFS of 4.70 months.
- Part 2 - Arm H: Nivolumab + Chemotherapy showed a median PFS of 8.34 months.
- Part 2 - Arm I: Chemotherapy showed a median PFS of 5.52 months.
- Part 3 -Arm J: Nivolumab + Ipilimumab showed a median PFS of 5.78 months.
- Part 3 - Arm K: Chemotherapy showed a median PFS of 5.49 months.
- For "Overall Survival":
- Part 1-Arm B: Nivo + Ipi showed a median OS of 17.12 months.
- Part 1-Arm A: Nivolumab showed a median OS of 15.70 months.
Key analyses also reported several Hazard Ratios (HRs):
- A Hazard Ratio (HR) of 0.79 (95.0% CI: 0.67 to 0.93).
- A Hazard Ratio (HR) of 0.95 (95.0% CI: 0.81 to 1.12).
- A Hazard Ratio (HR) of 0.85 (95.0% CI: 0.72 to 0.99).
- A Cox Proportional Hazard of 0.76 (95.0% CI: 0.6 to 0.97).
- A Hazard Ratio (HR) of 0.74 (95.0% CI: 0.59 to 0.93).
- A Hazard Ratio (HR) of 0.61 (95.0% CI: 0.52 to 0.72).
What this means
The results from this Phase 3 study provide insights into the efficacy of nivolumab in various combinations for Stage IV NSCLC. Notably, the combination of nivolumab plus chemotherapy in Part 2 demonstrated an extended median progression-free survival compared to chemotherapy alone. The reported hazard ratios suggest potential benefits for some nivolumab-containing regimens, indicating improved outcomes in terms of progression or survival compared to control arms. These findings contribute to the understanding of immuno-oncology approaches in advanced lung cancer.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT02477826, titled "An Investigational Immuno-therapy Trial of Nivolumab, or Nivolumab Plus Ipilimumab, or Nivolumab Plus Platinum-doublet Chemotherapy, Compared to Platinum Doublet Chemotherapy in Patients With Stage IV Non-Small Cell Lung Cancer (NSCLC)," were posted on 2025-10-30 on clinicaltrials.gov.