Clinical trial for Carcinoma, Non-Small-Cell Lung
Official title 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
ClinicalTrials.gov ID: NCT06119581
What this study is testing
What is LY3537982 (Olomorasib)?
An investigational oral medicine being studied as a potential treatment for advanced non‑small‑cell lung cancer with a KRAS G12C mutation.
Also referred to as Olomorasib.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see if adding olomorasib to standard cancer treatments works better than standard treatments alone for people who have not yet been treated for advanced non‑small‑cell lung cancer with a KRAS G12C mutation.
- Who it's for
- It is looking for adults who have untreated advanced non‑small‑cell lung cancer that has a KRAS G12C gene change.
- What's involved
- Participants may receive olomorasib, chemotherapy, and/or a drug called pembrolizumab, and will have regular doctor visits and tests to monitor their cancer and health.
- Time commitment
- The study could last up to 3 years, with multiple visits and follow‑up appointments as needed.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically or cytologically confirmed NSCLC with Stage IIIB-IIIC or Stage IV disease, not suitable for curative intent radical surgery or...
- 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 (%).
You likely can't join if
- Have a documented additional validated targetable oncogenic driver mutation or alteration in genes such as epidermal growth factor receptor (EGFR)...
- Have known active central nervous system metastases and/or carcinomatous meningitis.
- 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...
- Is unable or unwilling to take folic acid or vitamin B12 supplementation.
See the full eligibility 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
- 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...
- 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...
- Is unable or unwilling to take folic acid or vitamin B12 supplementation.
The study team makes the final eligibility decision.
Where it is enrolling
- Huntsville, Alabama, United States
- Gilbert, Arizona, United States
- Phoenix, Arizona, United States
- Tucson, Arizona, United States
- Springdale, Arkansas, United States
- Los Angeles, California, United States
- Walnut Creek, California, United States
- Lone Tree, Colorado, United States
- New Haven, Connecticut, United States
- Washington D.C., District of Columbia, United States
- Hollywood, Florida, United States
- Miami, Florida, United States
- Ocala, Florida, United States
- Orlando, Florida, United States
- St. Petersburg, Florida, United States
- Athens, Georgia, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Springfield, Illinois, United States
- Fort Wayne, Indiana, United States
+ 314 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Huntsville, Alabama, United States; Gilbert, Arizona, United States; Phoenix, Arizona, United States; Tucson, Arizona, United States; Springdale, Arkansas, United States; Los Angeles, California, United States and 328 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.