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Looking for participantsPhase3

A Study of First-Line Olomorasib (LY3537982) and Pembrolizumab With or Without Chemotherapy in Patients With Advanced KRAS G12C-Mutant Non-small Cell Lung Cancer

Sponsor: Eli Lilly and Company

NCT ID: NCT06119581

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
LY3537982 (drug), Pembrolizumab (drug), Placebo (drug), Cisplatin (drug)
How long the study runs
Study runs about 85 months (dates as stated)
About the drug or intervention
LY3537982 — drug: Administered orally. · Pembrolizumab — drug: Administered IV. · Placebo — drug: Administered orally. · Cisplatin — drug: Administered IV. · Carboplatin — drug: Administered IV. · Pemetrexed — drug: Administered IV.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
1,264
Started
2023-12-21
Last checked
2026-10

Plain English Summary

What is this study?

  • • Testing a new treatment for carcinoma, non-small-cell lung
  • • Phase3 - 1,264 participants
  • • The purpose of this study is to assess if adding LY3537982 (olomorasib) in combination with standard of care anti-cancer drugs is more effective than standard of care in participants with untreated advanced NSCLC

Who can take part?

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

Where?

  • • Aberdeen - Aberdeen Royal Infirmary
  • • Dundee - Ninewells Hospital and Medical School
  • • Huddersfield - Huddersfield Royal Infirmary
  • • Leeds - St James's University Hospital
  • • +4 more UK sites

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

About This Trial

The purpose of this study is to assess if adding LY3537982 (olomorasib) in combination with standard of care anti-cancer drugs is more effective than standard of care in participants with untreated advanced NSCLC. NSCLC must have a change in a gene called KRAS G12C. Study participation, including follow-up, could last up to 3 years, depending on how you and your lung cancer are doing.

More detail

Dose Optimization, Part A, and Part B are randomized. Safety Lead-In for Part B is single arm, non-randomized. Part C is non-randomized.

Carcinoma, Non-Small-Cell LungNeoplasm Metastasis

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:

  • • Tell us your age for better matching
  • • 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 negativeEGFRALKBRAFHER2MET

Treatment history

Treatments you must have had:

  • ✓ disease with evidence of KRAS G12C mutation
  • ✓ known programmed death-ligand 1 (PD-L1) expression
  • ✓ measurable disease per RECIST v1
  • ✓ an ECOG performance status of 0 or 1

What the study is looking for

  • ✓confirmed by testing a sample NSCLC with Stage IIIB-IIIC or Stage IV disease, not suitable for curative...
  • ✓Part B and Safety Lead-In Part B: the histology of the tumor must be predominantly non-squamous (in line with...
  • ✓Must have disease with evidence of KRAS G12C mutation.
  • ✓Must have known programmed death-ligand 1 (PD-L1) expression
  • ✓Part A: Greater than or equal to (≥)50 percent (%).

Who cannot take part

  • ✗Have had any of the following prior to randomization:
  • ✗\-- Prior treatment that goes through your whole body (drug treatment, treatment that helps your immune system fight cancer, treatment that targets specific changes in the cancer, or biological therapy) for advanced or...
  • ✗\--- 1 cycle of standard-of-care treatment prior to study enrollment will be allowed for cases where immediate...
  • ✗Have known active central nervous system metastases and/or carcinomatous meningitis.
  • ✗Exclusion Criteria for Participants receiving Pemetrexed and Platinum (Part B and Safety Lead-In Part B)
See the full criteria
Inclusion Criteria: * Histologically or cytologically confirmed NSCLC with Stage IIIB-IIIC or Stage IV disease, not suitable for curative intent radical surgery or radiation therapy. * Part B and Safety Lead-In Part B: the histology of the tumor must be predominantly non-squamous (in line with pemetrexed label). * Must have disease with evidence of KRAS G12C mutation. * Must have known programmed death-ligand 1 (PD-L1) expression * Part A: Greater than or equal to (≥)50 percent (%). * Part B: 0% to 100%. * Part C: \<50%. * Must have measurable disease per RECIST v1.1. * Must have an ECOG performance status of 0 or 1. * Estimated life expectancy ≥12 weeks. * Ability to swallow capsules. * 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 a documented additional validated targetable oncogenic driver mutation or alteration in genes such as epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), BRAF (V600E), human epidermal growth factor receptor 2 (HER2), MET (exon 14), ROS1, rearranged during transfection (RET), or neurotrophic tyrosine receptor kinase (NTRK)1/2/3. * Have had any of the following prior to randomization: \-- Prior systemic therapy (chemotherapy, immunotherapy, targeted therapy, or biological therapy) for advanced or metastatic NSCLC. \--- 1 cycle of standard-of-care treatment prior to study enrollment will be allowed for cases where immediate treatment is clinically indicated: * Have known active central nervous system metastases and/or carcinomatous meningitis. Exclusion Criteria for Participants receiving Pemetrexed and Platinum (Part B and Safety Lead-In Part B) * Have predominantly squamous cell histology for NSCLC * Only for participants with mild to moderate renal insufficiency: Unable to avoid aspirin, ibuprofen, or other nonsteroidal anti-inflammatory drugs (NSAIDs) two days before (5 days for long acting NSAIDs), day of, and two days after administration of pemetrexed * Is unable or unwilling to take folic acid or vitamin B12 supplementation.

Where Is This Study? (8 UK sites)

Aberdeen Royal Infirmary

Aberdeen AB25 2ZN, United Kingdom

Recruiting
Site contact (verified)
Andrew DuncanPrincipal Investigator

Ninewells Hospital and Medical School

Dundee DD1 9SY, United Kingdom

Recruiting
Site contact (verified)
Hannah LordPrincipal Investigator

Huddersfield Royal Infirmary

Huddersfield HD3 3EA, United Kingdom

Recruiting
Site contact (verified)
Emma RathbonePrincipal Investigator

St James's University Hospital

Leeds LS9 7TF, United Kingdom

Recruiting
Site contact (verified)
Katy ClarkePrincipal Investigator

The Christie NHS Foundation Trust

Manchester M20 4BX, United Kingdom

Recruiting
Site contact (verified)
Colin LindsayPrincipal Investigator

Mount Vernon Hospital

Northwood HA6 2RN, United Kingdom

Recruiting
Site contact (verified)
Andreas PolychronisPrincipal Investigator

Weston Park Hospital

Sheffield S10 2SJ, United Kingdom

Recruiting
Site contact (verified)
Tathagata DasPrincipal Investigator

New Cross Hospital

Wolverhampton WV10 0QP, United Kingdom

Recruiting
Site contact (verified)
Talha HafeezPrincipal 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