drugset / Trial / NCT06068153

AMG510 (sotorasib) Plus Lenvatinib As Second-line Treatment in Patients with KRASG12C Mutant, Metastatic NSCLC

NCT06068153 ↗

NaSingle-groupOpen-labelTreatment

Summary

AMBER is a multicentre, single-arm phase II trial. The protocol treatment consists of of sotorasib plus lenvatinib, as a second-line treatment. The primary objective of the trial is to evaluate the clinical efficacy of sotorasib plus lenvatinib, in terms of objective response rate, for patients with KRASG12C-mutant, metastatic NSCLC.

Timeline

Start
2025-03
Primary completion
2026-09-30
Completion
2026-12-30

Outcome

Outcome not reported

Stopped: “In view of the recent developments in the field (the increasing number of trials with new KRAS inhibitors), the window of opportunity to answer the question raised in the AMBER trial was missed.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Lenvatinib Small molecule 20 mg Oral
Subject Sotorasib Small molecule 960 mg Oral