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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
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
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
Where Is This Study? (8 UK sites)
Aberdeen Royal Infirmary
Aberdeen AB25 2ZN, United Kingdom
Ninewells Hospital and Medical School
Dundee DD1 9SY, United Kingdom
Huddersfield Royal Infirmary
Huddersfield HD3 3EA, United Kingdom
St James's University Hospital
Leeds LS9 7TF, United Kingdom
The Christie NHS Foundation Trust
Manchester M20 4BX, United Kingdom
Mount Vernon Hospital
Northwood HA6 2RN, United Kingdom
Weston Park Hospital
Sheffield S10 2SJ, United Kingdom
New Cross Hospital
Wolverhampton WV10 0QP, United Kingdom
How to Get in Touch
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Sponsor contactCONTACT
Physicians interested in becoming principal investigators please contact
Sponsor contactCONTACT
