Nivolumab with SBRT Shows Low Lung Toxicity in Early Stage NSCLC Trial

By Hipa.ai Research · July 17, 2026

Synced daily from openFDA and ClinicalTrials.gov. Last sync: July 19, 2026.

Results from a PHASE1/PHASE2 study (NCT03383302) investigating Nivolumab with stereotactic body radiotherapy (SBRT) for early stage non-small cell lung cancer were posted on 2026-07-17. The trial reported that 0 participants experienced lung toxicity (pneumonitis) from the treatment combination, indicating favorable tolerability.

Background

Nivolumab was investigated in combination with stereotactic body radiotherapy (SBRT) for the treatment of Non-small Cell Lung Cancer Stage II and Non-small Cell Lung Cancer Stage I.

Trial design

The study, identified as NCT03383302, was a single-arm, multi-center, open-label PHASE1/PHASE2 trial that enrolled 36 participants with Non-small Cell Lung Cancer Stage I or Stage II. The intervention involved administering nivolumab after stereotactic body radiotherapy (SBRT).

Key results

The study assessed lung toxicity (pneumonitis) and reported that 0 participants experienced this outcome from treatment with Nivolumab after SBRT for early stage NSCLC.

Adverse events (toxicity) by worst grade in the Arm 1 Tolerability group were reported as:

Grade 1: 1 participant
Grade 2: 11 participants
Grade 3: 16 participants
Grade 4: 1 participant

The proportion of participants receiving specific numbers of Nivolumab doses within 16 weeks of commencing adjuvant Nivolumab after SBRT were:

1 dose: 1.00 proportion of participants
2 doses: 0.90 proportion of participants
3 doses: 0.83 proportion of participants
4 doses: 0.79 proportion of participants
5 doses: 0.79 proportion of participants
6 doses: 0.76 proportion of participants

The disease relapse rate was reported as 0.03 proportion of participants (95% Confidence Interval).

What this means

The results suggest that the combination of Nivolumab with SBRT for early stage non-small cell lung cancer demonstrates a favorable safety profile concerning lung toxicity, with no participants experiencing pneumonitis. The observed adverse event grades provide further characterization of the treatment's tolerability. The high proportion of participants completing multiple doses of Nivolumab within the initial 16 weeks indicates good adherence to the treatment regimen. A low disease relapse rate of 0.03 proportion of participants is also a notable finding from this study.

Source

This information was sourced from ClinicalTrials.gov, documenting the results of trial NCT03383302, which were posted on 2026-07-17. The study details are available on clinicaltrials.gov.