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NCT06119581 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Carcinoma, Non-Small Cell Lung and Neoplasm Metastasis, sponsored by Eli Lilly and Company.

Recruiting
Registry status
Phase 3
Development phase
1,264
Enrollment target
20
Study locations

NCT06119581: Recruiting Phase 3 study of Carcinoma, Non-Small Cell Lung and Neoplasm Metastasis, sponsored by Eli Lilly and Company.

NCT06119581 is a Phase 3 study of Carcinoma, Non-Small Cell Lung and Neoplasm Metastasis that is actively recruiting participants, run by Eli Lilly and Company. The registered enrollment target is 1,264 participants, above the 314-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (303% higher). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06119581, a Phase 3 study of Carcinoma, Non-Small Cell Lung and Neoplasm Metastasis, is actively recruiting participants, sponsored by Eli Lilly and Company.

RECRUITING
Registry status
Phase 3
Development phase
1,264 participants
Enrollment target
20
Study locations

Study Summary

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.

Primary Outcome

Dose Optimization and Safety Lead-In Part B: Number of Participants with a TEAE

Conditions Studied

Carcinoma, Non-Small Cell Lung Neoplasm Metastasis

Interventions

  • DRUG Pembrolizumab
  • DRUG Carboplatin
  • DRUG Placebo
  • DRUG Cisplatin
  • DRUG LY3537982

Study Locations (20)

Florida

  • Millennium Oncology Research Clinic - Hollywood
  • University of Florida - Jacksonville - Jacksonville
  • Miami Cancer Institute at Baptist Health, Inc. - Miami
  • Ocala Oncology Center PL DBA Florida Cancer Affiliates - Ocala - Ocala
  • Comprehensive Hematology Oncology - St. Petersburg

California

  • Cedars-Sinai Medical Center - Los Angeles
  • Mercy Cancer Center - Merced
  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center - Torrance
  • BASS Cancer Center - Walnut Creek

Arizona

  • Banner MD Anderson Cancer Center - Gilbert
  • Banner University Medical Center Phoenix - Phoenix
  • The University of Arizona Cancer Center - North Campus - Tucson

Georgia

  • University Cancer & Blood Center, LLC - Athens
  • Emory University School of Medicine- Grady Campus - Atlanta
  • Winship Cancer Institute, Emory University - Atlanta

Alabama

  • Clearview Cancer Institute - Huntsville

Arkansas

  • Highlands Oncology Group - Springdale

Colorado

  • USO - Rocky Mountain Cancer Centers - Lone Tree

Connecticut

  • Yale University School of Medicine - New Haven

Trial Details

FieldValue
Enrollment Target 1,264 participants
Start Date 2023-12-21
Est. Completion 2031-01
Phase Phase 3
Eli Lilly and Company

1,341 total trials

What NCT06119581 shows while recruiting

NCT06119581 is an interventional study that assigns participants to a tested intervention. Its 1,264 participants enrollment target places it among the larger protocols in the corpus, above the 314-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (303% higher).

The record links to 2 conditions, with Carcinoma, Non-Small Cell Lung appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.

NCT06119581 names 20 study sites across 9 states, led by Florida, California, Arizona.

Frequently Asked Questions

What is clinical trial NCT06119581 about?

NCT06119581 is a clinical study titled "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". 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 fo...

What is the current status of trial NCT06119581?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 1,264 participants. The study started on 2023-12-21. Estimated completion is 2031-01.

What conditions does trial NCT06119581 study?

This clinical trial studies the following conditions: Carcinoma, Non-Small Cell Lung, Neoplasm Metastasis.

What interventions are being tested in trial NCT06119581?

The interventions under investigation include: Pembrolizumab (DRUG), Carboplatin (DRUG), Placebo (DRUG), Cisplatin (DRUG), LY3537982 (DRUG).

Who is sponsoring clinical trial NCT06119581?

This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06119581 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Carcinoma, Non-Small Cell Lung

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06119581's enrollment target sits among peer trials

1,264 3rd of 130 higher than 128 of 130 other Carcinoma, Non-Small Cell Lung trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Carcinoma, Non-Small Cell Lung trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT06119581

Source: ClinicalTrials.gov NCT06119581, the US trial registry maintained by the National Library of Medicine. NCT06119581 (large enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.