Study of Olomorasib (LY3537982) in Combination With Standard of Care in Participants With Resected or Unresectable KRAS G12C-mutant Non-Small Cell Lung Cancer

Purpose

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.

Condition

  • Carcinoma, Non-Small-Cell Lung

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Histological or cytological confirmation of NSCLC. - Part A 1. Clinical Stage II-IIIB (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 (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 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

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)
Masking Description
Both Part A and B are randomized, double-blind, placebo-controlled.

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Drug: Olomorasib
    Administered orally.
    Other names:
    • LY3537982
  • Drug: Pembrolizumab
    Administered intravenously (IV).
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.
  • Drug: Pembrolizumab
    Administered intravenously (IV).
  • Drug: Placebo
    Administered orally.
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.
  • Drug: Olomorasib
    Administered orally.
    Other names:
    • LY3537982
  • Drug: Durvalumab
    Administered IV.
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.
  • Drug: Durvalumab
    Administered IV.
  • Drug: Placebo
    Administered orally.

Recruiting Locations

Clearview Cancer Institute
Huntsville, Alabama 35805

The University of Arizona Cancer Center - North Campus
Tucson, Arizona 85719
Contact:
520-626-3434

Highlands Oncology Group
Springdale, Arkansas 72762
Contact:
479-872-8130

Profound Research LLC
Oceanside, California 92056

Stanford Cancer Center
Palo Alto, California 94304
Contact:
650-725-3081

Kaiser Permanente San Diego Mission Road
San Diego, California 92108

BASS Cancer Center
Walnut Creek, California 94598

Hartford Hospital (HH)
Hartford, Connecticut 06102

Boca Raton Regional Hospital
Boca Raton, Florida 33486

Florida Cancer Specialists - South
Fort Myers, Florida 33901

University of Florida - Jacksonville
Jacksonville, Florida 32209

Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida 33176

Florida Cancer Specialists North
St. Petersburg, Florida 33701-4553

Comprehensive Hematology Oncology
St. Petersburg, Florida 33709
Contact:
727-344-6569

Moffitt Cancer Center
Tampa, Florida 33612
Contact:
813-745-2677

Florida Cancer Specialists East
West Palm Beach, Florida 33401

University of Illinois at Chicago
Chicago, Illinois 60612

University of Chicago Medical Center
Chicago, Illinois 60637
Contact:
773-834-5387

Captain James A. Lovell Federal Health Care Center
North Chicago, Illinois 60064

Springfield Clinic Main Campus
Springfield, Illinois 62703

Parkview Research Center at Parkview Regional Medical Center
Fort Wayne, Indiana 46845

Franciscan Health
Indianapolis, Indiana 46237
Contact:
317-528-5173

Baptist Health Lexington
Lexington, Kentucky 40503

Baptist Health Hamburg
Lexington, Kentucky 40509

CHI Saint Joseph Cancer Center - East
Lexington, Kentucky 40509

Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana 70809
Contact:
225-215-1185

Ochsner Health Ochsner Cancer Center - Baton Rouge
Baton Rouge, Louisiana 70816
Contact:
504-842-3910

Ochsner Clinic Foundation
New Orleans, Louisiana 70121
Contact:
504-842-3910

New England Cancer Specialists
Westbrook, Maine 04092
Contact:
207-303-3300

University of Maryland
Baltimore, Maryland 21201

Reliant Medical Group
Worcester, Massachusetts 01606
Contact:
508-556-5400

Missouri Baptist Medical Center
St Louis, Missouri 63131

Jefferson Health - Cherry Hill
Cherry Hill, New Jersey 08002

Sidney Kimmel Cancer Center - Washington Township
Sewell, New Jersey 08080

Columbia University Irving Medical Center
New York, New York 10032
Contact:
212-305-3997

Memorial Sloan Kettering Cancer Center
New York, New York 10065
Contact:
646-608-3761

Cleveland Clinic
Cleveland, Ohio 44195

Providence Portland Medical Center
Portland, Oregon 97213

Providence St. Vincent Medical Center
Portland, Oregon 97225

Kaiser Permanente Interstate Medical Office Central
Portland, Oregon 97227
Contact:
503-249-3315

Oregon Health and Science University
Portland, Oregon 97239
Contact:
971-262-9000

Thomas Jefferson University, Sidney Kimmel Cancer Center - Clinical Trials Office
Philadelphia, Pennsylvania 19107

Jefferson Hospital Northeast
Philadelphia, Pennsylvania 19114

AHN Allegheny General Hospital
Pittsburgh, Pennsylvania 15212

Lexington Medical Center
West Columbia, South Carolina 29169
Contact:
803-794-7511

Tennessee Oncology Chattanooga
Chattanooga, Tennessee 37404

University of Tennessee Medical Center
Knoxville, Tennessee 37920
Contact:
865-305-8780

Sarah Cannon Research Institute
Nashville, Tennessee 37203

SCRI Oncology Partners
Nashville, Tennessee 37203

Tennessee Oncology
Nashville, Tennessee 37203

The Center for Cancer and Blood Disorders
Fort Worth, Texas 76104
Contact:
817-759-7000

Houston Methodist Hospital
Houston, Texas 77030
Contact:
713-441-9948

University of Texas MD Anderson Cancer Center
Houston, Texas 77030
Contact:
713-792-6363

USO - Texas Oncology - San Antonio
San Antonio, Texas 78240

USO - Texas Oncology Gulf Coast
Sugar Land, Texas 77479

USO - US Oncology Research Network
The Woodlands, Texas 77380

The University of Vermont Medical Center Inc.
Burlington, Vermont 05405

University of Virginia Health System
Charlottesville, Virginia 22903
Contact:
434-924-4251

VCU Health Adult Outpatient Pavillion
Richmond, Virginia 23219
Contact:
804-828-7999

Swedish Cancer Institute - Edmonds
Edmonds, Washington 98026

Swedish Medical Center
Seattle, Washington 98104

Cancer Care Northwest - Vercler
Spokane Valley, Washington 99216

Northwest Cancer Specialists PC
Vancouver, Washington 98684

Medical College of Wisconsin
Milwaukee, Wisconsin 53226

More Details

Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
LillyTrials@Lilly.com