Status: Active Trial | Marker: KRAS

Title

A Phase 3 Multicenter, Randomized, Open Label, Active-controlled, Study of AMG 510 Versus Docetaxel for the Treatment of Previously Treated Locally Advanced and Unresectable or Metastatic NSCLC Subjects With Mutated KRAS p.G12C

Study Number

NCT04303780

Indication

Histologically or pathologically documented, locally-advanced and unresectable or metastatic NSCLC with KRAS p.G12C mutation

Primary Objective

The safety and tolerability of AMG 510 compared to docetaxel will be assessed

In- and exclusion Criteria

• Have documentation of KRAS p.G12C mutation
• Subjects will have received and progressed or experienced disease recurrence on or after at least 1 prior systemic therapy for locally advanced and unresectable or metastatic disease. Prior treatment must include a platinum-based doublet chemotherapy and checkpoint inhibitor for advanced or metastatic disease, either given as one line of therapy or as individual lines of therapy unless the subject has a medical contraindication to one of the required therapies. If the subject has a medical contraindication to a required therapy, the subject may be enrolled only after the investigator discusses and obtains approval from the Amgen medical monitor

Study Design

Phase III, multicenter, randomized, two-arm study

Responsibilities

AMGEN INC
One Amgen Center Drive
Thousand Oaks, CA, 91320
Telephone Number: +1 805-447-1000

Trial Centre

University Hospital of Cologne
Dep. I of Internal Medicine
Phone: +49 221 478 87008
Fax: +49 221 478 87010
E-Mail: lungenkrebs@uk-koeln.de

Principal investigator

Prof. Dr. Jürgen Wolf

Letzte Änderung: 1. October 2020