Olomorasib and Pembrolizumab for Lung Cancer Treatment
Study of Olomorasib (LY3537982) in Combination With Standard of Care in Participants With Resected or Unresectable KRAS G12C-mutant Non-Small Cell Lung Cancer
Recruiting
Phase 3Interventional Study
Carcinoma, Non-Small-Cell Lung
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
700 (estimated)
Sponsor
Eli Lilly and Company · Industry
Who this trial is looking for
This trial is looking for participants with a specific type of lung cancer. If you join, you'll receive olomorasib along with other treatments to see how well they work together.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with non-small cell lung cancer.
I have a KRAS G12C mutation.
I have good overall health with an ECOG performance status of 0 or 1.
I can take oral medications.
I am using birth control according to local guidelines.
I have a negative pregnancy test if I am a woman of childbearing potential.
I have not had breastfed during treatment.
I have had adequate lab test results.
You may not be able to join if
I have known changes in the EGFR or ALK genes.
I have another type of cancer that is active or being treated.
I have an active autoimmune disease that needed treatment in the last 2 years.
I had severe side effects from previous immunotherapy.
I had any unresolved immune-related side effects.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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-mutan…
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.
Trial Locations
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City
State
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Status
Eligibility Criteria
Inclusion Criteria:
* Histological or cytological confirmation of NSCLC.
* Part A
1. 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.
2. Patholo…
Inclusion Criteria:
* Histological or cytological confirmation of NSCLC.
* Part A
1. 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.
2. 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
Exclusion Criteria:
* 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 people with hormone-related diseases who are now on stable hormone replacement therapy.
Contacts
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
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