Recruiting
Phase 3

Olomorasib & Standard of Care

Sponsor:

Eli Lilly and Company

Code:

NCT06890598

Conditions

Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Olomorasib

Pembrolizumab

Durvalumab

Placebo

Study Details

Brief summary:

The main purpose of this study is to assess if olomorasib in combination with pembrolizumab is more effective than the pembrolizumab and placebo combination in part A in participants with resected KRAS G12C-mutant NSCLC and to assess if olomorasib in combination with durvalumab is more effective than the durvalumab and placebo combination in part B in participants with unresectable KRAS G12C-mutant non-small cell lung cancer. The study may last up to 3 years for each participant.

Conditions

Carcinoma, Non-Small-Cell Lung

Study ID

NCT06890598

Start date

Mar 27, 2025

Status verified date

Aug, 2026

Completion date

Feb, 2032

Anticipated

Primary completion date

May, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Histological or cytological confirmation of NSCLC.

  • Part A

1. Clinical Stage II-IIIB (N0, N1, N2) treated with presurgical chemoimmunotherapy, with residual tumor present at time of surgery. Patients with a pathologic complete response are not eligible.
2. Pathologic Stage II-IIIB (N0, N1, N2) NSCLC treated with initial upfront resection.
  • Part B - Clinical Stage III, unresectable NSCLC, without progression on concurrent platinum-based chemoradiotherapy.
  • Must have disease with evidence of KRAS G12C mutation.
  • Must have known programmed death-ligand 1 (PD-L1) expression
  • Must have an ECOG performance status of 0 or 1.
  • Able to swallow oral medication.
  • Must have adequate laboratory parameters.
  • Contraceptive use should be consistent with local regulations for those participating in clinical studies.
  • Women of childbearing potential must

  • Have a negative pregnancy test.
  • Not be breastfeeding during treatment

Exclusion Criteria:

  • Have known, actionable changes in the EGFR or ALK genes.
  • Have another type of cancer that is progressing or required active treatment within the past 2 years before screening.
  • Have an active autoimmune disease that required systemic treatment in the past 2 years. Endocrine replacement therapy is allowed.
  • Had any immune-related side effect or allergic reaction (Grade 3 or higher) from a previous immunotherapy medicine, or any immune-related side effect greater than Grade 1 that has not resolved. This does not apply for people with hormone-related diseases who are now on stable hormone replacement therapy.

Study Design

Enrollment

700 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part A: Olomorasib + Pembrolizumab

Participants will receive olomorasib administered orally in combination with pembrolizumab intravenously (IV) for up to 1 year followed by olomorasib alone for up to 3 years of total treatment.

placebo comparator: Part A: Placebo + Pembrolizumab

Participants will receive placebo administered orally in combination with pembrolizumab administered IV for up to 1 year followed by placebo alone for up to 3 years of total treatment.

experimental: Part B: Olomorasib + Durvalumab

Participants will receive olomorasib administered orally in combination with durvalumab administered IV for up to 1 year followed by olomorasib alone for up to 3 years of total treatment.

placebo comparator: Part B: Placebo + Durvalumab

Participants will receive placebo administered orally in combination with durvalumab administered IV for up to 1 year followed by placebo alone for up to 3 years of total treatment.

Interventions

Olomorasib

Administered orally.

Pembrolizumab

Administered intravenously (IV).

Durvalumab

Administered IV.

Placebo

Administered orally.

Primary outcome measure

  • Part A: Disease-Free Survival (DFS) by Investigator Assessment [ Time Frame: Randomization to disease recurrence or death from any cause (Estimated as approximately 4 years). ]
  • Part B: Progression-Free Survival (PFS) by BICR [ Time Frame: Randomization to disease progression or death from any cause (Estimated as approximately 3 years). ]

Central Contacts and Locations

Central contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

Locations

Clearview Cancer Institute

Recruiting

Huntsville, Alabama, United States, 35805

Principal Investigator:

Jorge Diaz

The University of Arizona Cancer Center - North Campus

Recruiting

Tucson, Arizona, United States, 85719

Contacts

520-626-3434

Principal Investigator:

Linda Garland

Highlands Oncology Group

Recruiting

Springdale, Arkansas, United States, 72762

Contacts

479-872-8130

Principal Investigator:

Eric Schaefer

Profound Research LLC

Recruiting

Oceanside, California, United States, 92056

Principal Investigator:

Catherine Quinn

Stanford Cancer Center

Recruiting

Palo Alto, California, United States, 94304

Contacts

650-725-3081

Principal Investigator:

Joel Neal

Kaiser Permanente San Diego Mission Road

Recruiting

San Diego, California, United States, 92108

Principal Investigator:

Eric McGary

BASS Cancer Center

Recruiting

Walnut Creek, California, United States, 94598

Principal Investigator:

Jewel Johl

Hartford Hospital (HH)

Recruiting

Hartford, Connecticut, United States, 06102

Principal Investigator:

Wylie Hosmer

Sibley Memorial Hospital

Recruiting

Washington D.C., District of Columbia, United States, 20016

Principal Investigator:

Kristen Marrone

Boca Raton Regional Hospital

Recruiting

Boca Raton, Florida, United States, 33486

Principal Investigator:

Samuel Kareff

Florida Cancer Specialists - South

Recruiting

Fort Myers, Florida, United States, 33901

Principal Investigator:

Fadi Kayali

University of Florida - Jacksonville

Recruiting

Jacksonville, Florida, United States, 32209

Principal Investigator:

Pablo Santana

Miami Cancer Institute at Baptist Health, Inc.

Recruiting

Miami, Florida, United States, 33176

Principal Investigator:

Bruna Pellini

Ocala Oncology Center PL DBA Florida Cancer Affiliates - Ocala

Recruiting

Ocala, Florida, United States, 34474

Contacts

352-732-4032

Principal Investigator:

Ketan Doshi

Florida Cancer Specialists North

Recruiting

St. Petersburg, Florida, United States, 33701-4553

Principal Investigator:

Ernesto Bustinza-Linares

Comprehensive Hematology Oncology

Recruiting

St. Petersburg, Florida, United States, 33709

Contacts

727-344-6569

Principal Investigator:

Neeharika Makani

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Contacts

813-745-2677

Principal Investigator:

Jhanelle Gray

Florida Cancer Specialists East

Recruiting

West Palm Beach, Florida, United States, 33401

Principal Investigator:

Eric Michael Harris

Winship Cancer Institute

Recruiting

Atlanta, Georgia, United States, 30322

Principal Investigator:

Jennifer Carlisle

University of Illinois at Chicago

Recruiting

Chicago, Illinois, United States, 60612

Principal Investigator:

Frank Weinberg

University of Chicago Medical Center

Recruiting

Chicago, Illinois, United States, 60637

Contacts

773-834-5387

Principal Investigator:

Marina Garassino

Captain James A. Lovell Federal Health Care Center

Recruiting

North Chicago, Illinois, United States, 60064

Principal Investigator:

Mukta Pant-Purohit

Springfield Clinic Main Campus

Recruiting

Springfield, Illinois, United States, 62703

Principal Investigator:

Preet Singh

Parkview Research Center at Parkview Regional Medical Center

Recruiting

Fort Wayne, Indiana, United States, 46845

Principal Investigator:

patricia Rich

Franciscan Health

Recruiting

Indianapolis, Indiana, United States, 46237

Contacts

317-528-5173

Principal Investigator:

Michael Eaton

Baptist Health Lexington

Recruiting

Lexington, Kentucky, United States, 40503

Principal Investigator:

Firas Badin

Baptist Health Hamburg

Recruiting

Lexington, Kentucky, United States, 40509

Principal Investigator:

Firas Badin

CHI Saint Joseph Cancer Center - East

Recruiting

Lexington, Kentucky, United States, 40509

Principal Investigator:

Nicola Jabbour

Mary Bird Perkins Cancer Center

Recruiting

Baton Rouge, Louisiana, United States, 70809

Contacts

225-215-1185

Principal Investigator:

Victor Lin

Ochsner Health Ochsner Cancer Center - Baton Rouge

Recruiting

Baton Rouge, Louisiana, United States, 70816

Contacts

504-842-3910

Principal Investigator:

Ralph Millett

Ochsner Clinic Foundation

Recruiting

New Orleans, Louisiana, United States, 70121

Contacts

504-842-3910

Principal Investigator:

Ralph Millett

New England Cancer Specialists

Recruiting

Westbrook, Maine, United States, 04092

Contacts

207-303-3300

Principal Investigator:

Christian Thomas

University of Maryland

Recruiting

Baltimore, Maryland, United States, 21201

Principal Investigator:

Samuel Rosner

Johns Hopkins Bayview Medical Center

Recruiting

Baltimore, Maryland, United States, 21224

Principal Investigator:

Kristen Marrone

Reliant Medical Group

Recruiting

Worcester, Massachusetts, United States, 01606

Contacts

508-556-5400

Principal Investigator:

Bradley Switzer

Karmanos Cancer Institute

Recruiting

Detroit, Michigan, United States, 48201

Principal Investigator:

Khalil Choucair

Missouri Baptist Medical Center

Recruiting

St Louis, Missouri, United States, 63131

Principal Investigator:

Bryan Faller

Jefferson Health - Cherry Hill

Recruiting

Cherry Hill, New Jersey, United States, 08002

Principal Investigator:

Sarah Gordon

Sidney Kimmel Cancer Center - Washington Township

Recruiting

Sewell, New Jersey, United States, 08080

Principal Investigator:

Sarah Gordon

Columbia University Irving Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

212-305-3997

Principal Investigator:

Benjamin Herzberg

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

646-608-3761

Principal Investigator:

Jamie Chaft

Aultman Hospital

Recruiting

Canton, Ohio, United States, 44710

Contacts

330-438-6333

Principal Investigator:

Raza Khan

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Principal Investigator:

Lukas Delasos

OhioHealth Riverside Methodist Hospital

Recruiting

Columbus, Ohio, United States, 43214

Principal Investigator:

Elizabeth Kander

Providence Portland Medical Center

Recruiting

Portland, Oregon, United States, 97213

Principal Investigator:

Rachel Sanborn

Providence St. Vincent Medical Center

Recruiting

Portland, Oregon, United States, 97225

Principal Investigator:

Rachel Sanborn

Kaiser Permanente Interstate Medical Office Central

Recruiting

Portland, Oregon, United States, 97227

Contacts

503-249-3315

Principal Investigator:

Sandeep Mashru

Oregon Health and Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

971-262-9000

Principal Investigator:

naga praneeth raja

Thomas Jefferson University, Sidney Kimmel Cancer Center - Clinical Trials Office

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Principal Investigator:

Sarah Gordon

Jefferson Hospital Northeast

Recruiting

Philadelphia, Pennsylvania, United States, 19114

Principal Investigator:

Sarah Gordon

AHN Allegheny General Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15212

Principal Investigator:

Ariel Lopez-Chavez

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Principal Investigator:

Mariam Alexander

Lexington Medical Center

Recruiting

West Columbia, South Carolina, United States, 29169

Contacts

803-794-7511

Principal Investigator:

Scott Graupner

Avera Cancer Institute- Research

Recruiting

Sioux Falls, South Dakota, United States, 57105

Contacts

605-322-6900

Principal Investigator:

Benjamin Solomon

Tennessee Oncology Chattanooga

Recruiting

Chattanooga, Tennessee, United States, 37404

Principal Investigator:

Wade Iams

University of Tennessee Medical Center

Recruiting

Knoxville, Tennessee, United States, 37920

Contacts

865-305-8780

Principal Investigator:

Ardy Davarifar

Sarah Cannon Research Institute

Recruiting

Nashville, Tennessee, United States, 37203

Principal Investigator:

SMO Sarah Cannon Research Inst.

SCRI Oncology Partners

Recruiting

Nashville, Tennessee, United States, 37203

Principal Investigator:

Melissa Johnson

Tennessee Oncology

Recruiting

Nashville, Tennessee, United States, 37203

Principal Investigator:

Wade Iams

The Center for Cancer and Blood Disorders

Recruiting

Fort Worth, Texas, United States, 76104

Contacts

817-759-7000

Principal Investigator:

Ray Page

Houston Methodist Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

713-441-9948

Principal Investigator:

Jun Zhang

University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

713-792-6363

Principal Investigator:

Marcelo Vailati Negrao

USO - Texas Oncology - San Antonio

Recruiting

San Antonio, Texas, United States, 78240

Principal Investigator:

Krishna Alluri

USO - Texas Oncology Gulf Coast

Recruiting

Sugar Land, Texas, United States, 77479

Principal Investigator:

Caesar Tin-U

USO - US Oncology Research Network

Recruiting

The Woodlands, Texas, United States, 77380

Principal Investigator:

SMO Sarah Cannon Research Inst.

The University of Vermont Medical Center Inc.

Recruiting

Burlington, Vermont, United States, 05405

Principal Investigator:

Rohit Singh

University of Virginia Health System

Recruiting

Charlottesville, Virginia, United States, 22903

Contacts

434-924-4251

Principal Investigator:

Ryan Gentzler

VCU Health Adult Outpatient Pavillion

Recruiting

Richmond, Virginia, United States, 23219

Contacts

804-828-7999

Principal Investigator:

Renato Martins

Swedish Cancer Institute - Edmonds

Recruiting

Edmonds, Washington, United States, 98026

Principal Investigator:

Perrin Romine

Swedish Medical Center

Recruiting

Seattle, Washington, United States, 98104

Principal Investigator:

Perrin Romine

Cancer Care Northwest - Vercler

Recruiting

Spokane Valley, Washington, United States, 99216

Principal Investigator:

Maury Blitman

Northwest Cancer Specialists PC

Recruiting

Vancouver, Washington, United States, 98684

Principal Investigator:

Anthony Van Ho

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Principal Investigator:

Hui-Zi Chen

More Information

Sponsor

Eli Lilly and Company

Last update posted

Aug 24, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-08-24.