Trials / Withdrawn
WithdrawnNCT06068153
AMG510 (sotorasib) Plus Lenvatinib As Second-line Treatment in Patients with KRASG12C Mutant, Metastatic NSCLC
A Multicentre, Single-arm Phase II Trial of Sotorasib Plus Lenvatinib, As Second-line Treatment in Patients with KRASG12C-mutant, Metastatic NSCLC
- Status
- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- ETOP IBCSG Partners Foundation · Network
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Sotorasib | Sotorasib is administered at a dose of 960 mg (8x 120 mg) orally, once daily until progression or unacceptable toxicity. |
| DRUG | Lenvatinib | Lenvatinib is administered at a dose of 20 mg orally (2x 10 mg), once daily until progression or unacceptable toxicity. |
Timeline
- Start date
- 2025-03-01
- Primary completion
- 2026-09-30
- Completion
- 2026-12-30
- First posted
- 2023-10-05
- Last updated
- 2024-11-20
Locations
15 sites across 4 countries: Austria, Germany, Spain, Switzerland
Source: ClinicalTrials.gov record NCT06068153. Inclusion in this directory is not an endorsement.