Trial results for a Phase 2 study (NCT03285321) comparing nivolumab alone versus nivolumab plus ipilimumab in unresectable Stage III Non-small Cell Lung Cancer (NSCLC) were posted on ClinicalTrials.gov on 2025-03-11. The study showed similar 18-month progression-free survival rates of 65.5% for nivolumab alone and 66.3% for the combination therapy.
Background
Nivolumab is an immunotherapy drug. This study investigated its use as consolidation immunotherapy following concurrent chemoradiation in patients with unresectable Stage III Non-small Cell Lung Cancer (NSCLC).
Trial design
The Phase 2 study (NCT03285321) was an open-label, multicenter, randomized trial that enrolled 105 participants with unresectable Stage III Non-small Cell Lung Cancer (NSCLC). The trial compared consolidation immunotherapy with nivolumab alone (Arm 1) against the combination of nivolumab and ipilimumab (Arm 2), both following concurrent chemoradiation.
Key results
The trial reported the following key measurements:
- For Progression Free Survival (PFS) at 18-month:
- Arm 1: Nivolumab showed 65.5% of participants.
- Arm 2: Nivolumab Plus Ipilimumab showed 66.3% of participants.
- For Overall Survival (OS):
- Arm 1: Nivolumab had a median OS of 32 Months.
- For Time to Metastatic Disease (TTMD) at 36 Month:
- Arm 1: Nivolumab showed 79.7% of participants.
- Arm 2: Nivolumab Plus Ipilimumab showed 77.5% of participants.
- Regarding the Number of Participants With Adverse Events:
- Arm 1: Nivolumab had 54 Participants with adverse events.
- Arm 2: Nivolumab Plus Ipilimumab had 51 Participants with adverse events.
What this means
The results suggest that in patients with unresectable Stage III NSCLC receiving consolidation immunotherapy, nivolumab alone demonstrated comparable 18-month progression-free survival and 36-month time to metastatic disease rates to the combination of nivolumab and ipilimumab. The number of participants experiencing adverse events was also similar between both treatment arms. These findings provide insights into the efficacy and safety profiles of these immunotherapy approaches in this specific patient population.
Source
The information for these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT03285321, titled "Unresectable Stage IIIA/IIIB Non-small Cell Lung Cancer (NSCLC)," were posted on 2025-03-11 on clinicaltrials.gov.