Statistical analysis
DISEASE
The study planned to enroll approximately 29 patients in the cetuximab combination cohorts. This study was intended to obtain preliminary safety, pharmacokinetic and antitumor activity information and the sample sizes do not reflect any power and type I considerations. The data cutoff date was 01 April 2023 with an enrollment cutoff of 07 October 2022. This analysis included all patients who received at least one dose of divarasib and cetuximab. The response rate was reported for patients with measurable disease at baseline and summarized with 95% CIs calculated using the Clopper–Pearson method. The time-to-event end points, including time to response, duration of response and PFS, were reported descriptively and were summarized using the Kaplan–Meier method; median estimates were reported with 95% CIs.