ClinicalTrials.gov recorded primary completion on 20 March 2023 for a completed Phase 3 trial evaluating nivolumab plus sitravatinib versus docetaxel in advanced non-squamous non-small cell lung cancer. Median overall survival was 12.22 months with nivolumab and sitravatinib, compared with 10.58 months with docetaxel.

Background

The study involved patients with metastatic non-squamous non-small cell lung cancer whose disease had progressed on or after platinum-based chemotherapy and checkpoint inhibitor therapy. Its stated purpose was to compare the efficacy of investigational sitravatinib combined with nivolumab against docetaxel in this treatment setting.

Trial design

This completed Phase 3 study, identified as NCT03906071, enrolled 577 participants. The listed interventions were nivolumab, sitravatinib, and docetaxel. Participants were assigned to a nivolumab-plus-sitravatinib group or a docetaxel group. The registry record listed overall survival as an outcome and reported no primary-outcome entries.

Key results

Median overall survival was 12.22 months in the nivolumab-and-sitravatinib group and 10.58 months in the docetaxel group. The record did not provide numerical values for the associated 95% confidence intervals.

Two log-rank analyses reported hazard ratios of 0.86 (95% CI, 0.70 to 1.05; p=0.144) and 0.85 (95% CI, 0.70 to 1.04; p=0.108). The registry supplied no outcome titles for these analyses, so the available data do not identify which specific reported comparison each analysis represents.

The record also listed treatment-emergent adverse-event participant counts for the two groups as 280 versus 272, 215 versus 216, 128 versus 102, 214 versus 136, and 187 versus 110, respectively. It did not specify the event categories associated with these counts in the supplied data.

What this means

The reported measurements showed a longer median overall survival with nivolumab plus sitravatinib than with docetaxel, although the listed hazard-ratio analyses had p-values of 0.144 and 0.108. The supplied record does not establish a definitive comparative efficacy conclusion or provide enough event labeling to interpret the adverse-event counts.

Source

Source: ClinicalTrials.gov, registry results for the completed Phase 3 study of sitravatinib plus nivolumab versus docetaxel in advanced non-squamous non-small cell lung cancer, with primary completion recorded 20 March 2023. Available at clinicaltrials.gov/study/NCT03906071.