Trial results for a Phase 2 study (NCT03573947) investigating nivolumab in combination with ipilimumab and paclitaxel for untreated metastatic non-small cell lung cancer (NSCLC) were posted on ClinicalTrials.gov on 2025-10-14. The study reported a median progression-free survival (PFS) of 9.4 months for the combination therapy.

Background

This Phase 2 clinical trial evaluated the safety and efficacy of a triple combination regimen involving nivolumab, ipilimumab, and paclitaxel in patients with treatment-naïve metastatic non-small cell lung cancer (NSCLC).

Trial design

The study (NCT03573947) was an open-label, non-randomized, Phase 2 clinical trial. It enrolled 46 participants with untreated metastatic non-small cell lung cancer. The interventions investigated were nivolumab, ipilimumab, and paclitaxel administered in combination. The study's objectives included assessing progression-free survival and the safety profile of the combination.

Key results

The trial reported a median progression-free survival (PFS) of 9.4 months for the combination of nivolumab, ipilimumab, and paclitaxel, as determined by the investigator using RECIST 1.1 criteria.

Regarding the safety and adverse events of the combination, several participant counts were reported under the outcome "Description of the Safety and Adverse Events of the Combination Nivolumab, Ipilimumab, and Paclitaxel in Untreated, Metastatic NSCLC." Specific details of these events were not provided, but the reported participant counts were: 24, 17, 16, 15, 10, 10, 9, 8, 7, and 7 Participants.

For the outcome "Estimate the Overall Response Rate With the Study Combination," 2 Participants were reported.

What this means

The results from this Phase 2 trial provide preliminary efficacy and safety data for the combination of nivolumab, ipilimumab, and paclitaxel in patients with previously untreated metastatic non-small cell lung cancer. A median PFS of 9.4 months suggests potential clinical activity for this triple regimen in this patient population. While specific adverse event details are not provided in the posted results, the reported participant counts indicate that safety was assessed. These findings contribute to the understanding of combination immunotherapies in advanced NSCLC.

Source

The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT03573947, titled "Phase II Clinical Trial of NIVO-IPI-TAXANE in Untreated Metastatic NSCLC," were posted on 2025-10-14 on clinicaltrials.gov.