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New treatment option for Carcinoma, Non-Small-Cell Lung
Official title Study of Olomorasib (LY3537982) in Combination With Standard of Care in Participants With Resected or Unresectable KRAS G12C-mutant Non-Small Cell Lung Cancer
ClinicalTrials.gov ID: NCT06890598
What this study is testing
What is Olomorasib?
Olomorasib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for carcinoma, non-small-cell lung.
Also referred to as LY3537982.
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 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
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
- 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 of surgery. Patients with a...
- 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.
You likely can't join if
- 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...
See the full eligibility criteria
- 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 of surgery. Patients with a pathologic complete response are not eligible.
- 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
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Huntsville, Alabama, United States
- Mobile, Alabama, United States
- Phoenix, Arizona, United States
- Tucson, Arizona, United States
- Springdale, Arkansas, United States
- Los Angeles, California, United States
- Oceanside, California, United States
- Orange, California, United States
- Palo Alto, California, United States
- San Diego, California, United States
- Walnut Creek, California, United States
- Hartford, Connecticut, United States
- Washington D.C., District of Columbia, United States
- Boca Raton, Florida, United States
- Fort Meyers, Florida, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Ocala, Florida, United States
- St. Petersburg, Florida, United States
- Tampa, Florida, United States
+ 269 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 - 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?
Study sites include Huntsville, Alabama, United States; Mobile, Alabama, United States; Phoenix, Arizona, United States; Tucson, Arizona, United States; Springdale, Arkansas, United States; Los Angeles, California, United States and 283 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.