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Active Not RecruitingPhase 1NCT06607185
Official study title

A Study of the Pan-KRAS Inhibitor LY4066434 in Participants With KRAS Mutant Solid Tumors

Study summary

The main purpose of the study is to assess whether the study drug, LY4066434, is safe and tolerable when administered to participants with locally advanced or metastatic solid tumors with certain KRAS mutations. LY4066434 will be given alone or in combination with other treatments. The study will have 2 parts: monotherapy dose escalation and dose optimization. The study is expected to last up to approximately 5 years.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedLY4066434. and Cetuximab

Plus 10 other study approaches.

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

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jul 20, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Active Not Recruiting

The study is underway but is not accepting new participants.

What kind of study?Phase 1

Interventional

Where is it offered?45 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
Sponsor
Eli Lilly and Company
Interventions being studied
Drug: LY4066434.; Drug: Cetuximab; Drug: Nab paclitaxel; Drug: Gemcitabine; Drug: Oxaliplatin; Drug: Leucovorin; Drug: Irinotecan; Drug: 5Fluorouracil; Drug: Carboplatin; Drug: Cisplatin; Drug: Pemetrexed; Drug: Pembrolizumab
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)→
Disease setting
Locally advanced→Metastatic or stage IV→
Biomarkers
KRAS→
Treatment approach
Immunotherapy→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
  • Have evidence of KRAS G12C, G12D, G12V, G12A, G12S, or G13D mutation in tumor tissue or circulating tumor DNA
  • Histological or cytologically proven diagnosis of a locally advanced, unresectable, and/or metastatic solid tumor cancer
  • Have measurable disease per RECIST 1.1
  • Have an ECOG performance status of ≤1
  • Must not be pregnant and/or planning to breastfeed during the trial or within 180 days of the last dose of trial intervention
  • Must be able to swallow tablets
  • Participants with asymptomatic or treated CNS disease may be eligible
Reasons someone may not be able to joinExclusion criteria
  • Have known active CNS metastases and/or carcinomatous meningitis
  • Have any unresolved toxicities from prior therapy greater than NCI CTCAE Version 5.0 Grade 1 at the time of starting trial treatment, except for alopecia, hearing loss, peripheral neuropathy and ongoing endocrinopathies controlled on appropriate replacement therapy
  • Have significant cardiovascular disease defined as unstable angina or acute coronary syndrome, history of myocardial infarction, known left ventricular ejection fraction or heart failure, uncontrolled or symptomatic arrhythmias.
  • Have known active hepatitis B virus (HBV), hepatitis C virus (HCV) or untreated HIV infection
  • Have other active malignancy unless in remission with life expectancy greater than 2 years.
  • Have active uncontrolled systemic bacterial, viral, fungal, or parasitic infection
  • Have history of non-infectious pneumonitis/interstitial lung disease that received steroids or has current clinically significant pneumonitis/interstitial lung disease

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

  • University of Alabama at BirminghamBirmingham, Alabama
  • Mayo ClinicPhoenix, Arizona
  • City of HopeDuarte, California
  • University of California, Los Angeles (UCLA)Santa Monica, California
  • Yale University School of Medicine - Yale Cancer CenterNew Haven, Connecticut
  • The University of Chicago Medical Center (UCMC)Chicago, Illinois
  • Indiana University (IU)Indianapolis, Indiana
  • Massachusetts General HospitalBoston, Massachusetts
  • Dana-Farber Cancer InstituteBoston, Massachusetts
  • South Texas Accelerated Research Therapeutics (START) MidwestGrand Rapids, Michigan
  • Columbia UniversityNew York, New York
  • David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer CenterNew York, New York

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 20, 2026. Always confirm current availability with the study team.

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