RECRUITING

Study of LY3537982 in Cancer Patients With a Specific Genetic Mutation (KRAS G12C)

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Conditions

Carcinoma, Non-Small-Cell LungColorectal NeoplasmsEndometrial NeoplasmsOvarian NeoplasmsPancreatic NeoplasmsBiliary Tract NeoplasmsFrontline1LFirst Line

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to find out whether the study drug, LY3537982, is safe and effective in cancer patients who have a specific genetic mutation (KRAS G12C). Patients must have already received or were not able to tolerate the standard of care, except for specific groups who have not had cancer treatment. The study will last up to approximately 4 years.

Official Title

A Phase 1/2 Study of LY3537982 in Patients With KRAS G12C-Mutant Advanced Solid Tumors

Quick Facts

Study Start:2021-07-19
Study Completion:2026-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04956640

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients have measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
  2. * Patients must have disease with evidence of KRAS G12C mutation in tumor tissue or circulating tumor deoxyribonucleic acid (DNA).
  3. * Participants must have a histological or a cytologically proven diagnosis of locally advanced, unresectable, and/or metastatic cancer and meet cohort-specific criteria.
  4. * Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  5. * Have adequate organ function.
  6. * Have discontinued all previous treatments for cancer with resolution of any significant ongoing adverse events (AEs), (except in certain scenarios).
  7. * Must be able to swallow capsule/tablet.
  8. * Agree and adhere to contraceptive use, if applicable.
  9. * For some parts of the study, (i.e., one of the two arms with LY3537982 in combination with pembrolizumab and the arm of LY3537982 in combination with pembrolizumab, pemetrexed, and platinum therapy) histologically or cytologically confirmed Stage IIIB-IIIC or Stage IV NSCLC that is previously untreated in the advanced/metastatic setting and not suitable for curative intent radical surgery or radiation therapy. Previously untreated patients who received adjuvant and neoadjuvant therapy are eligible if the last dose of the systemic treatment was completed at least 6 months prior to enrollment. For untreated patients in the arm with LY3537982 in combination with pembrolizumab noted above, a single cycle of pembrolizumab may be initiated within 21 days prior to enrollment. For untreated patients in the arm of LY3537982 in combination with pembrolizumab, pemetrexed, and platinum therapy, a single cycle of any or all of the drugs other than LY3537982 may be initiated within 21 days prior to enrollment. Start of study treatment may be delayed to allow sufficient time for recovery from treatment-related toxicity.
  10. * For one part of the study, participants must have received at least one prior oxaliplatin- or irinotecan-containing regimen for advanced or metastatic CRC.
  1. * Disease suitable for local therapy administered with curative intent.
  2. * Have an active, ongoing, or untreated infection.
  3. * Have a serious pre-existing medical condition(s) that, in the judgment of the investigator, would preclude participation in this study.
  4. * Have a serious cardiac condition.
  5. * Have a second active primary malignancy or have been diagnosed and/or treated for an additional malignancy within 3 years prior to enrollment.
  6. * For some parts of the study only: have untreated active central nervous system (CNS) metastases and/or leptomeningeal disease. Patients with treated CNS metastases are eligible for this study if their disease is asymptomatic, radiographically stable for at least 30 days, and they do not require treatment with steroids in the two-week period prior to study treatment. Patients with active CNS metastases are eligible for one part of the study.
  7. * Have received prior treatment with any KRAS G12C small molecule inhibitor, except in certain scenarios where such prior therapy is allowed as per protocol.
  8. * The following patients will be excluded from some parts of the study:
  9. * Experienced certain serious side effects with prior immunotherapy.
  10. * Have an active autoimmune disease that has required systemic anti-autoimmune treatment in the past 2 years.
  11. * Have received a live vaccine within 30 days prior to the first dose of study drug.
  12. * Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial through 180 days after the last dose of study medication.
  13. * Known allergic reaction against any of the components of the study treatments.

Contacts and Locations

Study Contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
CONTACT
13176154559
ClinicalTrials.gov@lilly.com

Principal Investigator

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

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35233
United States
USC Norris Cancer Hospital
Los Angeles, California, 90033
United States
Chao Family Comprehensive Cancer Ctr.
Orange, California, 92868
United States
Yale-New Haven Hospital
New Haven, Connecticut, 06510
United States
AdventHealth Orlando
Orlando, Florida, 32803
United States
Florida Cancer Specialists
Sarasota, Florida, 34236
United States
Indiana Univ Melvin & Bren Simon Cancer Center
Indianapolis, Indiana, 46202
United States
Community Health Network
Indianapolis, Indiana, 46250
United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
United States
NYU Langone Health- Long Island
Mineola, New York, 11501
United States
NYU Langone
New York, New York, 10016
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
United States
Novant Health Cancer Institute - Elizabeth
Charlotte, North Carolina, 28204
United States
Novant Health Cancer Institute - Forsyth
Winston-Salem, North Carolina, 27103
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111-2497
United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
United States
Sarah Cannon Cancer Center
Nashville, Tennessee, 37203
United States
Vanderbilt Univeristy School of Medicine
Nashville, Tennessee, 37212-6303
United States
South Texas Accelerated Research Therapeutics (START)
San Antonio, Texas, 78229-3307
United States
START Mountain Region
West Valley City, Utah, 84119
United States
Inova Health System IRB
Fairfax, Virginia, 22031
United States
USO-Virginia Cancer Specialists, PC
Fairfax, Virginia, 22031
United States
University of Wisconsin-Madison Hospital and Health Clinic
Madison, Wisconsin, 53792-4108
United States

Collaborators and Investigators

Sponsor: Eli Lilly and Company

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-07-19
Study Completion Date2026-06

Study Record Updates

Study Start Date2021-07-19
Study Completion Date2026-06

Terms related to this study

Keywords Provided by Researchers

  • Frontline
  • 1L
  • First Line

Additional Relevant MeSH Terms

  • Carcinoma, Non-Small-Cell Lung
  • Colorectal Neoplasms
  • Endometrial Neoplasms
  • Ovarian Neoplasms
  • Pancreatic Neoplasms
  • Biliary Tract Neoplasms