Olomorasib and Pembrolizumab for Advanced Lung Cancer

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

Recruiting Phase 3 Interventional Study
Carcinoma, Non-Small-Cell Lung Neoplasm Metastasis
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
1,264 (estimated)
Sponsor
Eli Lilly and Company · Industry
Who this trial is looking for

This trial is looking for people with advanced lung cancer that has a specific gene mutation called KRAS G12C. Participants will receive a combination of new and standard treatments and will be followed for up to 3 years.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have been diagnosed with advanced non-small cell lung cancer.
  • I have a KRAS G12C mutation.
  • I have measurable disease according to RECIST criteria.
  • I have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • I expect to live at least 12 more weeks.
  • I can swallow capsules.
  • I can use birth control if needed.
  • I have a known level of PD-L1 expression.

You may not be able to join if

  • I have another targetable gene mutation.
  • I have had previous treatment for advanced lung cancer.
  • I have active brain metastases or cancer in my cerebrospinal fluid.
  • I have predominantly squamous cell lung cancer.
  • I can't take aspirin or similar medications as required.
  • I am unable or unwilling to take folic acid or vitamin B12 supplements.

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?

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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.

Trial Locations
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Eligibility Criteria
Inclusion 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 peme…
Contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559

LillyTrials@Lilly.com

CONTACT

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

CONTACT