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TerminatedPhase 1 / Phase 2NCT04165031
Official study title

A Study of LY3499446 in Participants With Advanced Solid Tumors With KRAS G12C Mutation

Study summary

The reason for this study is to see if the study drug LY3499446 is safe and effective in participants with solid tumors with KRAS G12C mutation.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedLY3499446 and Abemaciclib

Plus 3 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · KRAS

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Nov 24, 2021 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?6 U.S. locations

Locations may change over time.

Who runs it?Eli Lilly and Company

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1 / Phase 2
Sponsor
Eli Lilly and Company
Interventions being studied
Drug: LY3499446; Drug: Abemaciclib; Drug: Cetuximab; Drug: Erlotinib; Drug: Docetaxel
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Biomarkers
KRAS→
Treatment approach
Chemotherapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • Participants must have diagnosis of a solid tumor with KRAS G12C mutation that did not respond to at least 1 line of standard therapy and has spread to other part(s) of the body
  • For phase II, participants must be willing to have new tumor tissue biopsies (doctor removes a small amount of tissue) during the study if it does not cause undue risks to health
  • Participants must be willing to use highly effective birth control
  • Participants must have adequate organ function
  • Participants must be able to swallow capsules
Reasons someone may not be able to joinExclusion criteria
  • Participants must not have certain infections such as hepatitis or tuberculosis or HIV that is not well controlled
  • Participants must not have another serious medical condition including a serious heart condition, such as congestive heart failure, unstable angina pectoris, or heart attack within the last three months
  • Participants must not have cancer of the central nervous system that is not stable
  • Participants must not be pregnant or breastfeeding
  • Participants must not use herbal supplements

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Indiana Univ Melvin & Bren Simon Cancer CenterIndianapolis, Indiana
  • Memorial Sloan Kettering Cancer CenterMiddletown, New Jersey
  • Memorial Sloan Kettering Cancer CenterHarrison, New York
  • Memorial Sloan Kettering Cancer CenterNew York, New York
  • St Vincent's HospitalDarlinghurst, New South Wales
  • Linear Clinical Research LtdNedlands, Western Australia

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 24, 2021. Always confirm current availability with the study team.

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