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

Description

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

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Study Overview

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Study Details

Study overview

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.

A Phase 3, Multicenter, Double-Blind, Placebo-controlled Study Assessing the Efficacy and Safety of Olomorasib in Combination With Standard of Care Immunotherapy in Participants With Resected or Unresectable KRAS G12C-Mutant, Non-Small Cell Lung Cancer - SUNRAY-02

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

Condition
Carcinoma, Non-Small-Cell Lung
Intervention / Treatment

-

Contacts and Locations

Huntsville

Clearview Cancer Institute, Huntsville, Alabama, United States, 35805

Tucson

The University of Arizona Cancer Center - North Campus, Tucson, Arizona, United States, 85719

Springdale

Highlands Oncology Group, Springdale, Arkansas, United States, 72762

Los Angeles

UCLA Hematology/Oncology - Santa Monica, Los Angeles, California, United States, 90404

Oceanside

Profound Research LLC, Oceanside, California, United States, 92056

Palo Alto

Stanford Cancer Center, Palo Alto, California, United States, 94304

San Diego

Kaiser Permanente San Diego Mission Road, San Diego, California, United States, 92108

Fort Myers

Florida Cancer Specialists - South, Fort Myers, Florida, United States, 33901

Jacksonville

University of Florida - Jacksonville, Jacksonville, Florida, United States, 32209

Saint Petersburg

Florida Cancer Specialists North, Saint Petersburg, Florida, United States, 33705

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Eli Lilly and Company,

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

2031-12