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.
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
- ✓ 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
Where Is This Study? (7 UK sites)
Heartlands Hospital
Birmingham B9 5SS, United Kingdom
University Hospitals Sussex NHS Foundation Trust
East Sussex BN2 5BE, United Kingdom
Huddersfield Royal Infirmary
Huddersfield HD3 3EA, United Kingdom
Royal Marsden Hospital (Sutton)
London SM2 5PT, United Kingdom
Royal Marsden Hospital (Chelsea)
London SW3 6JJ, United Kingdom
The Christie NHS Foundation Trust
Manchester M20 4BX, United Kingdom
Torbay Hospital
Torquay TQ2 7AA, 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
