Nivolumab Trial Reports Pathologic Responses in Lung Cancer

ClinicalTrials.gov posted results on 27 August 2026 for a randomized, open-label Phase 2 study of neoadjuvant nivolumab and platinum doublet chemotherapy, with or without sub-ablative stereotactic body radiation therapy. The trial enrolled 17 participants with resectable stage IIA to IIIB non-small cell lung cancer. Complete pathological responses were reported in 3 participants receiving nivolumab plus chemotherapy and 4 participants receiving the combination with SBRT.

Background

The study evaluated nivolumab with platinum doublet chemotherapy before surgery in participants with resectable stage IIA to IIIB non-small cell lung cancer. The investigational comparison added sub-ablative stereotactic body radiation therapy to the nivolumab and chemotherapy regimen. The registry record listed the study as active, not recruiting when the results were posted.

Trial design

NCT05500092 was an open-label, randomized Phase 2 study. It enrolled 17 participants with resectable stage IIA to IIIB non-small cell lung cancer. The treatment groups were nivolumab plus platinum doublet chemotherapy, or the same regimen with SBRT delivered at 8 Gy × 3. The registered study summary described the treatment as neoadjuvant therapy, meaning it was administered before surgical treatment.

The available data listed pathological response outcomes, including complete pathological response and major pathological response. No primary outcome entries, statistical analyses, p-values, confidence intervals, or adverse-event summary were supplied in the data provided.

Key results

For complete pathological response, the nivolumab plus platinum doublet chemotherapy group reported 3 participants. The group receiving nivolumab, platinum doublet chemotherapy, and SBRT reported 4 participants.

For major pathological response, the chemotherapy-only combination group reported 4 participants, while the group that also received SBRT reported 5 participants. These were participant counts; the supplied record did not provide denominators, percentages, comparative analyses, or measures of variability.

What this means

The posted results document pathological responses in both treatment groups in this small Phase 2 study. The reported counts were numerically higher in the group that added SBRT for both complete and major pathological response, but the available data do not establish whether that difference was statistically meaningful or attributable to SBRT.

The results do not indicate a new approval, a change in nivolumab’s labeled use, or a comparative safety conclusion. Interpretation is limited by the enrollment of 17 participants and the absence of supplied statistical analyses and adverse-event findings.

Source

Source: ClinicalTrials.gov, registry record for NCT05500092, “An Open Label, Randomized Study of Neoadjuvant Nivolumab and Chemotherapy, With or Without Sub-ablative Stereotactic Body Radiation Therapy, for Resectable Stage IIA to IIIB Non-small Cell Lung Cancer,” with results posted on 27 August 2026. The record is available at clinicaltrials.gov/study/NCT05500092.