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A Phase I/II Study of AMG 510 in Combination With MVASI in Patients With Advanced, Unresectable or Metastatic KRAS G12C Mutant NSCLC With Asymptomatic Brain Metastasis

NCT05180422 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2023-10-18

No results posted yet for this study

Summary

This is a multicenter, non-randomized, open-label, phase I/II study to evaluate the safety and tolerability of AMG 510 plus MVASI in subjects with advanced KRAS p.G12C mutant non-small cell lung cancer (NSCLC) with small, untreated brain metastases.

Conditions

  • Non Small Cell Lung Cancer

Interventions

DRUG

AMG 510

Continuous once daily (QD) oral dosing (Days 1-21 each cycle) with or without food.

DRUG

MVASI

Intravenous (i.v.) infusion every 21 days (i.e. Day 1 of each 21-day cycle).

Sponsors & Collaborators

  • Amgen

    collaborator INDUSTRY

  • Criterium, Inc.

    lead INDUSTRY

Principal Investigators

  • Wade Iams, MD, MSCI · Vanderbilt University Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-15
Primary Completion
2023-01-31
Completion
2023-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05180422 on ClinicalTrials.gov