ClinicalTrials.gov reported primary completion on 26 July 2023 for a Phase 3 trial of nivolumab plus chemotherapy in participants with surgically removable, early-stage non-small cell lung cancer. Among the reported results, pathologic complete response occurred in 25.3% of participants receiving nivolumab plus standard-of-care chemotherapy, compared with 4.7% receiving placebo plus chemotherapy.

The study evaluated treatment given before surgery and continued afterward, with the aim of determining whether this periadjuvant approach prolonged event-free survival. The registry listed the trial as active, not recruiting.

Background

The trial studied nivolumab in early-stage non-small cell lung cancer, or NSCLC, alongside chemotherapy. Registered chemotherapy interventions included carboplatin, cisplatin, paclitaxel, and pemetrexed. Participants underwent surgical removal after neoadjuvant treatment and then received adjuvant treatment with nivolumab or placebo.

Trial design

NCT04025879 was a Phase 3 study that enrolled 461 participants with carcinoma of the non-small cell lung. The comparison was nivolumab plus standard-of-care chemotherapy versus placebo plus standard-of-care chemotherapy, followed by surgery and adjuvant nivolumab or placebo. The main purpose was to examine event-free survival, assessed by blinded independent central review, in participants with surgically removable early-stage NSCLC.

Key results

Median event-free survival by blinded independent central review was not available for the nivolumab group in the supplied record and was 18.43 months for the placebo group. The listed Cox proportional-hazards analysis reported a hazard ratio of 0.58, with a 95% confidence interval of 0.43–0.78 and a log-rank p-value of 0.00025.

Pathologic complete response was 25.3% with nivolumab plus chemotherapy versus 4.7% with placebo plus chemotherapy. The reported difference was 20.5 percentage points, with a 95% confidence interval of 14.3–26.6; the listed odds ratio was 6.64, with a 95% confidence interval of 3.4–12.97.

Major pathologic response occurred in 35.4% of the nivolumab group and 12.1% of the placebo group. The difference was 23.2 percentage points, with a 95% confidence interval of 15.8–30.6; the odds ratio was 4.01, with a 95% confidence interval of 2.48–6.49.

  • Participants with adverse events: 222 with nivolumab plus chemotherapy and 225 with placebo plus chemotherapy.
  • Participants with serious adverse events: 96 with nivolumab and 71 with placebo.
  • Participants with select adverse events: 37 in each group.

What this means

In this registered trial, adding nivolumab to neoadjuvant chemotherapy was associated with higher pathologic complete and major pathologic response rates than chemotherapy plus placebo. The event-free survival analysis also favored the nivolumab group. The supplied record does not establish a new regulatory approval and does not provide a median event-free survival value for the nivolumab group.

Source

Source: ClinicalTrials.gov, trial-results record for NCT04025879, with the reported primary completion date of 26 July 2023. The registry record is available at clinicaltrials.gov/study/NCT04025879.