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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

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 3 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 4068590, Alabama 4829764 35805

The University of Arizona Cancer Center - North Campus
Tucson 5318313, Arizona 5551752 85719
Contact:
520-626-3434

Highlands Oncology Group
Springdale 4132093, Arkansas 4099753 72762
Contact:
479-872-8130

Profound Research LLC
Oceanside 5378771, California 5332921 92056

Stanford Cancer Center
Palo Alto 5380748, California 5332921 94304
Contact:
650-725-3081

Kaiser Permanente San Diego Mission Road
San Diego 5391811, California 5332921 92108

BASS Cancer Center
Walnut Creek 5406990, California 5332921 94598

Boca Raton Regional Hospital
Boca Raton 4148411, Florida 4155751 33486

Florida Cancer Specialists - South
Fort Myers 4155995, Florida 4155751 33901

University of Florida - Jacksonville
Jacksonville 4160021, Florida 4155751 32209

Florida Cancer Specialists North
St. Petersburg 4171563, Florida 4155751 33701-4553

Comprehensive Hematology Oncology
St. Petersburg 4171563, Florida 4155751 33709
Contact:
727-344-6569

Moffitt Cancer Center
Tampa 4174757, Florida 4155751 33612
Contact:
813-745-2677

Florida Cancer Specialists East
West Palm Beach 4177887, Florida 4155751 33401

University of Illinois at Chicago
Chicago 4887398, Illinois 4896861 60612

University of Chicago Medical Center
Chicago 4887398, Illinois 4896861 60637
Contact:
773-834-5387

Springfield Clinic Main Campus
Springfield 4250542, Illinois 4896861 62703

Parkview Research Center at Parkview Regional Medical Center
Fort Wayne 4920423, Indiana 4921868 46845

Franciscan Health
Indianapolis 4259418, Indiana 4921868 46237
Contact:
317-528-5173

Baptist Health Lexington
Lexington 4297983, Kentucky 6254925 40503

Baptist Health Hamburg
Lexington 4297983, Kentucky 6254925 40509

CHI Saint Joseph Cancer Center - East
Lexington 4297983, Kentucky 6254925 40509

Mary Bird Perkins Cancer Center
Baton Rouge 4315588, Louisiana 4331987 70809
Contact:
225-215-1185

New England Cancer Specialists
Westbrook 4982753, Maine 4971068 04092
Contact:
207-303-3300

Reliant Medical Group
Worcester 4956184, Massachusetts 6254926 01606
Contact:
508-556-5400

Missouri Baptist Medical Center
St Louis 4407066, Missouri 4398678 63131

Jefferson Health - Cherry Hill
Cherry Hill 4501198, New Jersey 5101760 08002

Sidney Kimmel Cancer Center - Washington Township
Sewell 4504048, New Jersey 5101760 08080

Columbia University Irving Medical Center
New York 5128581, New York 5128638 10032
Contact:
212-305-3997

Memorial Sloan Kettering Cancer Center
New York 5128581, New York 5128638 10065
Contact:
646-608-3761

Cleveland Clinic
Cleveland 5150529, Ohio 5165418 44195

Providence Portland Medical Center
Portland 5746545, Oregon 5744337 97213

Providence St. Vincent Medical Center
Portland 5746545, Oregon 5744337 97225

Kaiser Permanente Interstate Medical Office Central
Portland 5746545, Oregon 5744337 97227
Contact:
503-249-3315

Thomas Jefferson University, Sidney Kimmel Cancer Center - Clinical Trials Office
Philadelphia 4560349, Pennsylvania 6254927 19107

Jefferson Hospital Northeast
Philadelphia 4560349, Pennsylvania 6254927 19114

AHN Allegheny General Hospital
Pittsburgh 5206379, Pennsylvania 6254927 15212

Lexington Medical Center
West Columbia 4600541, South Carolina 4597040 29169
Contact:
803-794-7511

Tennessee Oncology Chattanooga
Chattanooga 4612862, Tennessee 4662168 37404

University of Tennessee Medical Center
Knoxville 4634946, Tennessee 4662168 37920
Contact:
865-305-8780

SCRI Oncology Partners
Nashville 4644585, Tennessee 4662168 37203

Tennessee Oncology
Nashville 4644585, Tennessee 4662168 37203

The Center for Cancer and Blood Disorders
Fort Worth 4691930, Texas 4736286 76104
Contact:
817-759-7000

Houston Methodist Hospital
Houston 4699066, Texas 4736286 77030
Contact:
713-441-9948

University of Texas MD Anderson Cancer Center
Houston 4699066, Texas 4736286 77030
Contact:
713-792-6363

USO - Texas Oncology - San Antonio
San Antonio 4726206, Texas 4736286 78240

USO - Texas Oncology Gulf Coast
Sugar Land 4734825, Texas 4736286 77479

University of Virginia Health System
Charlottesville 4752031, Virginia 6254928 22903
Contact:
434-924-4251

VCU Health Adult Outpatient Pavillion
Richmond 4781708, Virginia 6254928 23219
Contact:
804-828-7999

Cancer Care Northwest - Vercler
Spokane Valley 5811729, Washington 5815135 99216

Northwest Cancer Specialists PC
Vancouver 5814616, Washington 5815135 98684

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.