Study 3 (rolapitant, moderately emetogenic chemotherapy)

Study 3 was a randomised, double-blind, active-controlled phase 3 trial of oral rolapitant versus placebo, each with granisetron and dexamethasone, in patients receiving moderately emetogenic chemotherapy or anthracycline plus cyclophosphamide regimens at 170 centres in 23 countries. Patients received a single 180 mg oral dose of rolapitant or matching placebo one to two hours before cycle 1. The primary endpoint was complete response, meaning no vomiting and no rescue medication, in the delayed phase from more than 24 hours to 120 hours after the start of chemotherapy.

In the Lancet Oncology 2015 report, 1,369 patients were randomly assigned (684 rolapitant, 685 active control) and 666 per arm formed the modified intention-to-treat efficacy population. Delayed-phase complete response was achieved by 475 patients (71 percent) on rolapitant versus 410 (62 percent) on active control (odds ratio 1.6, 95 percent CI 1.2 to 2.0; p = 0.0002). Adverse events were similar between arms; neutropenia was the most common grade 3 to 4 event in cycle 1 (5 percent versus 3 percent), and no serious adverse event was treatment related.

The US Varubi label names the same study Study 3 and analyses the same 666 patients per arm alongside the two cisplatin-based studies, Studies 1 and 2. ClinicalTrials.gov lists organisation id TS-P04834 as a completed phase 3 with an actual enrolment of 1,369, matching the paper. The programme treats chemotherapy-induced nausea and vomiting rather than a named cancer, so the record carries no cancer ids.