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Looking for participantsPhase3

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

Sponsor: Eli Lilly and Company

NCT ID: NCT06890598

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Olomorasib (drug), Pembrolizumab (drug), Durvalumab (drug), Placebo (drug)
How long the study runs
Study runs about 83 months (dates as stated)
About the drug or intervention
Olomorasib — drug: Administered orally. · Pembrolizumab — drug: Administered intravenously (IV). · Durvalumab — drug: Administered IV. · Placebo — drug: Administered orally.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
700
Started
2025-03-27
Last checked
2026-10

Plain English Summary

What is this study?

  • • Testing a new treatment for carcinoma, non-small-cell lung
  • • Phase3 - 700 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with carcinoma, non-small-cell lung

Where?

  • • Birmingham - Heartlands Hospital
  • • East Sussex - University Hospitals Sussex NHS Foundation Trust
  • • Huddersfield - Huddersfield Royal Infirmary
  • • London - Royal Marsden Hospital (Sutton)
  • • +3 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Carcinoma, Non-Small-Cell Lung

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

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  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders
  • How fit you need to be: ECOG 0 or better

Biomarkers mentioned

KRASPD-L1Have a negativeEGFRALK

Treatment history

Treatments you must have had:

  • ✓ disease with evidence of KRAS G12C mutation
  • ✓ known programmed death-ligand 1 (PD-L1) expression
  • ✓ an ECOG performance status of 0 or 1
  • ✓ adequate laboratory parameters

What the study is looking for

  • ✓Histological or cytological confirmation of NSCLC.
  • ✓Part A
  • ✓Clinical Stage II-IIIB (N0, N1, N2) treated with presurgical chemoimmunotherapy, with residual tumor present at time...
  • ✓disease 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.

Who cannot take part

  • ✗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...
See the full criteria
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.

Where Is This Study? (7 UK sites)

Heartlands Hospital

Birmingham B9 5SS, United Kingdom

Recruiting
Site contact (verified)
Shobhit BaijalPrincipal Investigator

University Hospitals Sussex NHS Foundation Trust

East Sussex BN2 5BE, United Kingdom

Recruiting
Site contact (verified)
Kam ZakiPrincipal Investigator

Huddersfield Royal Infirmary

Huddersfield HD3 3EA, United Kingdom

Recruiting
Site contact (verified)
Emma RathbonePrincipal Investigator

Royal Marsden Hospital (Sutton)

London SM2 5PT, United Kingdom

Recruiting
Site contact (verified)
Sanjaykumar PopatPrincipal Investigator

Royal Marsden Hospital (Chelsea)

London SW3 6JJ, United Kingdom

Recruiting
Site contact (verified)
Sanjaykumar PopatPrincipal Investigator

The Christie NHS Foundation Trust

Manchester M20 4BX, United Kingdom

Recruiting
Site contact (verified)
Colin LindsayPrincipal Investigator

Torbay Hospital

Torquay TQ2 7AA, United Kingdom

Recruiting
Site contact (verified)
Louise MedleyPrincipal Investigator

How to Get in Touch

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

Sponsor contact

CONTACT

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

Physicians interested in becoming principal investigators please contact

Sponsor contact

CONTACT

clinical_inquiry_hub@lilly.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-10