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

Sponsor
ETOP IBCSG Partners Foundation
Study ID
NCT06068153
Phase
PHASE2
Status
Withdrawn

Conditions

  • KRAS G12C
  • Metastatic Non Small Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sotorasib — DRUG
    Sotorasib is administered at a dose of 960 mg (8x 120 mg) orally, once daily until progression or unacceptable toxicity.
  • Lenvatinib — DRUG
    Lenvatinib is administered at a dose of 20 mg orally (2x 10 mg), once daily until progression or unacceptable toxicity.

Study Details

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.

Key Dates

Start date
Mar 31, 2025
Status verified
Nov 2024
Primary completion
Sep 30, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Arm
    Sotorasib + Lenvatinib

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: From date of enrolment until 18 weeks post-enrolment. ]

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